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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-003819-23 | EudraCT Number | ||
| 19.4.306 | Other Identifier | Organon Protocol Number | |
| MK-8616-034 | Other Identifier | Merck Protocol Number | |
| P05961 | Other Identifier | Schering-Plough Protocol Number |
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The purpose of this study is:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex 0.5 mg/kg | Experimental | Participants are to receive an intravenous (IV) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex is to be given. |
|
| Sugammadex 1 mg/kg | Experimental | Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex is to be given. |
|
| Sugammadex 2 mg/kg | Experimental | Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex is to be given. |
|
| Sugammadex 4 mg/kg | Experimental | Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex is to be given. |
|
| Placebo | Placebo Comparator | Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single 3-mL bolus dose of placebo (sodium chloride 0.9% solution) is to be given. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex 0.5 mg/kg | Drug | IV infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 & T4 refer to the magnitudes (heights) of the first & fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached ≥0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB. | From start of sugammadex or palcebo administration to recovery of T4/T1 ratio to 0.9 (ranging from ~0.5 minutes to ~30 minutes from sugammadex or placebo administration) |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 & T4 refer to the magnitudes (heights) of the first & fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19194156 | Result | Plaud B, Meretoja O, Hofmockel R, Raft J, Stoddart PA, van Kuijk JH, Hermens Y, Mirakhur RK. Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. Anesthesiology. 2009 Feb;110(2):284-94. doi: 10.1097/ALN.0b013e318194caaa. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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One adolescent participant was inadvertently randomized to Children: Sugammadex 4 mg/kg, but was included in Adolescents: Sugammadex 4 mg/kg for safety analyses. One participant was randomized to Adolescents: Sugammadex 0.5 mg/kg, but received sugammadex 5.0 mg/kg & was included in the Adolescents: Sugammadex 4 mg/kg for safety analyses.
Recruited participants were stratified between Infants (28 days-23 months of age), Children (2-11 years of age), Adolescents (12-17 years of age) and Adults (18-65 years of age). For Participant Flow, participants are included in the treatment group to which they were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Infants: Placebo | Infant participants received an intravenous (IV) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. |
| FG001 | Infants: Sugammadex 0.5 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Sugammadex 1 mg/kg | Drug | IV infusion |
|
|
| Sugammadex 2 mg/kg | Drug | IV infusion |
|
|
| Sugammadex 4 mg/kg | Drug | IV infusion |
|
|
| Placebo | Drug | IV infusion |
|
|
| Rocuronium bromide | Drug | IV infusion |
|
|
| From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.7 (ranging from ~0.4 minutes to ~20 minutes from sugammadex or placebo administration) |
| Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 & T4 refer to the magnitudes (heights) of the first & fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB. | From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.8 (ranging from ~0.5 minutes to ~25 minutes from sugammadex or placebo administration) |
Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. |
| FG002 | Infants: Sugammadex 1 mg/kg | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered. |
| FG003 | Infants: Sugammadex 2 mg/kg | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. |
| FG004 | Infants: Sugammadex 4 mg/kg | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
| FG005 | Children: Placebo | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. |
| FG006 | Children: Sugammadex 0.5 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. |
| FG007 | Children: Sugammadex 1 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered |
| FG008 | Children: Sugammadex 2 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. |
| FG009 | Children: Sugammadex 4 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
| FG010 | Adolescents: Placebo | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. |
| FG011 | Adolescents: Sugammadex 0.5 mg/kg | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. |
| FG012 | Adolescents: Sugammadex 1 mg/kg | Adolescents participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered. |
| FG013 | Adolescents: Sugammadex 2 mg/kg | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. |
| FG014 | Adolescents: Sugammadex 4 mg/kg | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
| FG015 | Adults: Placebo | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. |
| FG016 | Adults: Sugammadex 0.5 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. |
| FG017 | Adults: Sugammadex 1 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered. |
| FG018 | Adults: Sugammadex 2 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. |
| FG019 | Adults: Sugammadex 4 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The All-Participants-Treated (APT) population consisted of all treated participants. Three additional participants withdrew from the study before receiving treatment & were not included in the Baseline Analysis Population. For the APT population, participants with incorrect randomization are included under the actual dose group they received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Infants: Placebo | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. |
| BG001 | Infants: Sugammadex 0.5 mg/kg | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. |
| BG002 | Infants: Sugammadex 1 mg/kg | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered. |
| BG003 | Infants: Sugammadex 2 mg/kg | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. |
| BG004 | Children: Placebo | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. |
| BG005 | Children: Sugammadex 0.5 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. |
| BG006 | Children: Sugammadex 1 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered |
| BG007 | Children: Sugammadex 2 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. |
| BG008 | Children: Sugammadex 4 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
| BG009 | Adolescents: Placebo | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. |
| BG010 | Adolescents: Sugammadex 0.5 mg/kg | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. |
| BG011 | Adolescents: Sugammadex 1 mg/kg | Adolescents participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered. |
| BG012 | Adolescents: Sugammadex 2 mg/kg | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. |
| BG013 | Adolescents: Sugammadex 4 mg/kg | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
| BG014 | Adults: Placebo | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. |
| BG015 | Adults: Sugammadex 0.5 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. |
| BG016 | Adults: Sugammadex 1 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered. |
| BG017 | Adults: Sugammadex 2 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. |
| BG018 | Adults: Sugammadex 4 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
| BG019 | Infants: Sugammadex 4 mg/kg | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
| BG020 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 & T4 refer to the magnitudes (heights) of the first & fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached ≥0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB. | The Per Protocol (PP) population consisted of all randomized participants who received a dose of study treatment (sugammadex or placebo) & had ≥1 post-baseline efficacy measurement for this outcome measure & had no protocol violations. For efficacy, participants with incorrect randomization were included under the planned dose group. | Posted | Mean | Standard Deviation | Minutes | From start of sugammadex or palcebo administration to recovery of T4/T1 ratio to 0.9 (ranging from ~0.5 minutes to ~30 minutes from sugammadex or placebo administration) |
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| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 & T4 refer to the magnitudes (heights) of the first & fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB. | The PP population consisted of all randomized participants who received a dose of study treatment (sugammadex or placebo) & had ≥1 post-baseline efficacy measurement for this outcome measure & had no protocol violations. For efficacy, participants with incorrect randomization were included under the planned dose group. | Posted | Mean | Standard Deviation | Minutes | From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.7 (ranging from ~0.4 minutes to ~20 minutes from sugammadex or placebo administration) |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 & T4 refer to the magnitudes (heights) of the first & fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB. | The PP population consisted of all randomized participants who received a dose of study treatment (sugammadex or placebo) & had ≥1 post-baseline efficacy measurement for this outcome measure & had no protocol violations. For efficacy, participants with incorrect randomization were included under the planned dose group. | Posted | Mean | Standard Deviation | Minutes | From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.8 (ranging from ~0.5 minutes to ~25 minutes from sugammadex or placebo administration) |
|
Through postoperative Day 7 (Up to 8 days)
The APT population consisted of all randomized participants who received a dose of study treatment (sugammadex or placebo). With respect to the APT population, participants with incorrect randomization were included under the actual dose group they received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infants: Placebo | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG001 | Infants: Sugammadex .0.5 mg/kg | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. | 0 | 2 | 1 | 2 | 1 | 2 |
| EG002 | Infants: Sugammadex 1 mg/kg | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG003 | Infants: Sugammadex 2 mg/kg | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG004 | Infants: Sugammadex 4 mg/kg | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG005 | Children: Placebo | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered | 0 | 4 | 0 | 4 | 3 | 4 |
| EG006 | Children: Sugammadex 0.5 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG007 | Children: Sugammadex 1 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered. | 0 | 5 | 0 | 5 | 2 | 5 |
| EG008 | Children: Sugammadex 2 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. | 0 | 5 | 0 | 5 | 2 | 5 |
| EG009 | Children: Sugammadex 4 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. | 0 | 4 | 1 | 4 | 4 | 4 |
| EG010 | Adolescents: Placebo | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered | 0 | 6 | 0 | 6 | 5 | 6 |
| EG011 | Adolescents: Sugammadex 0.5 mg/kg | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. | 0 | 5 | 0 | 5 | 3 | 5 |
| EG012 | Adolescents: Sugammadex 1 mg/kg | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG013 | Adolescents: Sugammadex 2 mg/kg | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG014 | Adolescents: Sugammadex 4 mg/kg | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG015 | Adults: Placebo | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered | 0 | 6 | 0 | 6 | 3 | 6 |
| EG016 | Adults: Sugammadex 0.5 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG017 | Adults: Sugammadex 1 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered. | 0 | 5 | 0 | 5 | 5 | 5 |
| EG018 | Adults: Sugammadex 2 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG019 | Adults: Sugammadex 4 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. | 0 | 6 | 0 | 6 | 3 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis viral | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Haematuria traumatic | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Postoperative fever | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Hyperkinesia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
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| Excitability | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
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| Scrotal oedema | Reproductive system and breast disorders | MedDRA 9.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
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Organon recognizes the right of the investigator(s) to publish, but all publications must be based on data validated by Organon. Any such scientific paper, presentation, or other communication concerning the clinical trial described in this protocol will first be submitted to Organon, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D012965 | Sodium Chloride |
| D012996 | Solutions |
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D004364 | Pharmaceutical Preparations |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
| Male |
|
Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered
| OG007 | Children: Sugammadex 2 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. |
| OG008 | Children: Sugammadex 4 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
| OG009 | Adolescents: Placebo | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. |
| OG010 | Adolescents: Sugammadex 0.5 mg/kg | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. |
| OG011 | Adolescents: Sugammadex 1 mg/kg | Adolescents participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered. |
| OG012 | Adolescents: Sugammadex 2 mg/kg | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. |
| OG013 | Adolescents: Sugammadex 4 mg/kg | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
| OG014 | Adults: Placebo | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. |
| OG015 | Adults: Sugammadex 0.5 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. |
| OG016 | Adults: Sugammadex 1 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered. |
| OG017 | Adults: Sugammadex 2 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. |
| OG018 | Adults: Sugammadex 4 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
| OG019 | Infants: Sugammadex 4 mg/kg | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
| OG002 | Infants: Sugammadex 1 mg/kg | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered. |
| OG003 | Infants: Sugammadex 2 mg/kg | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. |
| OG004 | Children: Placebo | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. |
| OG005 | Children: Sugammadex 0.5 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. |
| OG006 | Children: Sugammadex 1 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered |
| OG007 | Children: Sugammadex 2 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. |
| OG008 | Children: Sugammadex 4 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
| OG009 | Adolescents: Placebo | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. |
| OG010 | Adolescents: Sugammadex 0.5 mg/kg | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. |
| OG011 | Adolescents: Sugammadex 1 mg/kg | Adolescents participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered. |
| OG012 | Adolescents: Sugammadex 2 mg/kg | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. |
| OG013 | Adolescents: Sugammadex 4 mg/kg | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
| OG014 | Adults: Placebo | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. |
| OG015 | Adults: Sugammadex 0.5 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. |
| OG016 | Adults: Sugammadex 1 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered. |
| OG017 | Adults: Sugammadex 2 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. |
| OG018 | Adults: Sugammadex 4 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
| OG019 | Infants: Sugammadex 4 mg/kg | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
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|
| OG002 | Infants: Sugammadex 1 mg/kg | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered. |
| OG003 | Infants: Sugammadex 2 mg/kg | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. |
| OG004 | Children: Placebo | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. |
| OG005 | Children: Sugammadex 0.5 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. |
| OG006 | Children: Sugammadex 1 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered |
| OG007 | Children: Sugammadex 2 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. |
| OG008 | Children: Sugammadex 4 mg/kg | Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
| OG009 | Adolescents: Placebo | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. |
| OG010 | Adolescents: Sugammadex 0.5 mg/kg | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. |
| OG011 | Adolescents: Sugammadex 1 mg/kg | Adolescents participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered. |
| OG012 | Adolescents: Sugammadex 2 mg/kg | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. |
| OG013 | Adolescents: Sugammadex 4 mg/kg | Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
| OG014 | Adults: Placebo | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. |
| OG015 | Adults: Sugammadex 0.5 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex was administered. |
| OG016 | Adults: Sugammadex 1 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex was administered. |
| OG017 | Adults: Sugammadex 2 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex was administered. |
| OG018 | Adults: Sugammadex 4 mg/kg | Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
| OG019 | Infants: Sugammadex 4 mg/kg | Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex was administered. |
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