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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-001133-15 | EudraCT Number | ||
| MK-8616-031 | Other Identifier | Merck Protocol Number | |
| 19.4.209A | Other Identifier | Organon Protocol Number |
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The objective of the trial was to establish the dose-response relation of sugammadex (Org 25969) given as a reversal agent of rocuronium or vecuronium at 1-2 PTC during sevoflurane anesthesia for Japanese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex 0.5 mg/kg (Rocuronium) | Experimental | After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered intravenously (IV), followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the second twitch (T2) response to Train-of-four (TOF) stimulation, a single dose of 0.5 mg/kg sugammadex was administered IV. |
|
| Sugammadex 1.0 mg/kg (Rocuronium) | Experimental | After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 1.0 mg/kg sugammadex was administered IV. |
|
| Sugammadex 2.0 mg/kg (Rocuronium) | Experimental | After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 2.0 mg/kg sugammadex was administered IV. |
|
| Sugammadex 4.0 mg/kg (Rocuronium) | Experimental | After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 4.0 mg/kg sugammadex was administered IV. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | After induction of anesthesia an intubation dose of a neuromuscular blocking agent (NMBA) was administered IV: either 0.9 mg/kg rocuronium (arms 1-5) or 0.1 mg/kg vecuronium (arms 6-10). Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex (0.5 to 8.0 mg/kg) IV was administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.9 for Train-Of-Four (TOF) Stimulation | Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and 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. | Up to 269:45 (min:sec) |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.7 for TOF Stimulation | Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and 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 |
|---|---|---|---|
| 25693333 | Background | Takeda J, Iwasaki H, Otagiri T, Katoh T, Shingu K, Obara H, Nakatsuka H, Tomiyama Y, Kasaba T. [Efficacy and safety of sugammadex (Org 25969) in reversing deep neuromuscular block induced by rocuronium or vecuronium in Japanese patients]. Masui. 2014 Oct;63(10):1083-8. Japanese. |
| Label | URL |
|---|---|
| Click here to access a synopsis of the study results. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugammadex 0.5 mg/kg (Rocuronium) | Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 Post-tetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary |
| FG001 | Sugammadex 1.0 mg/kg (Rocuronium) | Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary |
| FG002 | Sugammadex 2.0 mg/kg (Rocuronium) | Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary |
| FG003 | Sugammadex 4.0 mg/kg (Rocuronium) | Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary |
| FG004 | Sugammadex 8.0 mg/kg (Rocuronium) | Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary |
| FG005 | Sugammadex 0.5 mg/kg (Vecuronium) | Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary |
| FG006 | Sugammadex 1.0 mg/kg (Vecuronium) | Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary |
| FG007 | Sugammadex 2.0 mg/kg (Vecuronium) | Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary |
| FG008 | Sugammadex 4.0 mg/kg (Vecuronium) | Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary |
| FG009 | Sugammadex 8.0 mg/kg (Vecuronium) | Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated Participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sugammadex 0.5 mg/kg (Rocuronium) | Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 Post-tetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary |
| BG001 | Sugammadex 1.0 mg/kg (Rocuronium) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.9 for Train-Of-Four (TOF) Stimulation | Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and 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 analysis population consisted of all randomized participants who were given at least one administration of sugammadex and had at least one post-baseline efficacy measurement, without any major protocol violation. | Posted | Mean | Standard Deviation | Minutes | Up to 269:45 (min:sec) |
|
Up to 7 post-operative days
All randomized participants who received at least one dose of study treatment and had follow-up.
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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 | Sugammadex 0.5 mg/kg (Rocuronium) | Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 Post-tetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
Not provided
| 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 |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
Not provided
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| Sugammadex 8.0 mg/kg (Rocuronium) | Experimental | After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV, followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 0.8 mg/kg sugammadex was administered IV. |
|
| Sugammadex 0.5 mg/kg (Vecuronium) | Experimental | After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 0.5 mg/kg sugammadex was administered IV. |
|
| Sugammadex 1.0 mg/kg (Vecuronium) | Experimental | After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 1.0 mg/kg sugammadex was administered IV. |
|
| Sugammadex 2.0 mg/kg (Vecuronium) | Experimental | After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 2.0 mg/kg sugammadex was administered IV. |
|
| Sugammadex 4.0 mg/kg (Vecuronium) | Experimental | After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 4.0 mg/kg sugammadex was administered IV. |
|
| Sugammadex 8.0 mg/kg (Vecuronium) | Experimental | After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV, followed by maintenance doses of 0.02-0.4 mg/kg vecuronium IV if necessary. At reappearance of the T2 response to TOF stimulation, a single dose of 8.0 mg/kg sugammadex was administered IV. |
|
|
|
| Up to 152:30 (min:sec) |
| Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.8 for TOF Stimulation | Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and 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. | Up to 194:45 (min:sec) |
Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary |
| BG002 | Sugammadex 2.0 mg/kg (Rcocuronium) | Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary |
| BG003 | Sugammadex 4.0 mg/kg (Rocuronium) | Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary |
| BG004 | Sugammadex 8.0 mg/kg (Rocuronium) | Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary |
| BG005 | Sugammadex 0.5 mg/kg (Vecuronium) | Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary |
| BG006 | Sugammadex 1.0 mg/kg (Vecuronium) | Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary |
| BG007 | Sugammadex 2.0 mg/kg (Vecuronium) | Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary |
| BG008 | Sugammadex 4.0 mg/kg (Vecuronium) | Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary |
| BG009 | Sugammadex 8.0 mg/kg (Vecuronium) | Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary |
| BG010 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG000 | Sugammadex 0.5 mg/kg (Rocuronium) | Sugammadex 0.5 mg/kg administered as a single-bolus intravenous (IV) dose at 1-2 Post-tetanic count (PTC) after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary |
| OG001 | Sugammadex 1.0 mg/kg (Rocuronium) | Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary |
| OG002 | Sugammadex 2.0 mg/kg (Rocuronium) | Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary |
| OG003 | Sugammadex 4.0 mg/kg (Rocuronium) | Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary |
| OG004 | Sugammadex 8.0 mg/kg (Rocuronium) | Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary |
| OG005 | Sugammadex 0.5 mg/kg (Vecuronium) | Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary |
| OG006 | Sugammadex 1.0 mg/kg (Vecuronium) | Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary |
| OG007 | Sugammadex 2.0 mg/kg (Vecuronium) | Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary |
| OG008 | Sugammadex 4.0 mg/kg (Vecuronium) | Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary |
| OG009 | Sugammadex 8.0 mg/kg (Vecuronium) | Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary |
|
|
| Secondary | Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.7 for TOF Stimulation | Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and 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 analysis population was the Per-Protocol (PP) group, which consisted of all randomized participants who were given at least one administration of sugammadex and had at least one post-baseline efficacy measurement, without any major protocol violation. | Posted | Mean | Standard Deviation | Minutes | Up to 152:30 (min:sec) |
|
|
|
| Secondary | Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.8 for TOF Stimulation | Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and 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 analysis population consisted of all randomized participants who were given at least one administration of sugammadex and had at least one post-baseline efficacy measurement, without any major protocol violation. | Posted | Mean | Standard Deviation | Minutes | Up to 194:45 (min:sec) |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 9 |
| 9 |
| EG001 | Sugammadex 1.0 mg/kg (Rocuronium) | Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary | 0 | 9 | 1 | 9 | 9 | 9 |
| EG002 | Sugammadex 2.0 mg/kg (Rocuronium) | Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary | 0 | 10 | 0 | 10 | 10 | 10 |
| EG003 | Sugammadex 4.0 mg/kg (Rocuronium) | Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary | 0 | 11 | 0 | 11 | 11 | 11 |
| EG004 | Sugammadex 8.0 mg/kg (Rocuronium) | Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary | 0 | 10 | 0 | 10 | 10 | 10 |
| EG005 | Sugammadex 0.5 mg/kg (Vecuronium) | Sugammadex 0.5 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary | 0 | 10 | 0 | 10 | 10 | 10 |
| EG006 | Sugammadex 1.0 mg/kg (Vecuronium) | Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary | 0 | 10 | 0 | 10 | 9 | 10 |
| EG007 | Sugammadex 2.0 mg/kg (Vecuronium) | Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary | 0 | 10 | 1 | 10 | 10 | 10 |
| EG008 | Sugammadex 4.0 mg/kg (Vecuronium) | Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary | 0 | 10 | 1 | 10 | 9 | 10 |
| EG009 | Sugammadex 8.0 mg/kg (Vecuronium) | Sugammadex 8.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.04 mg/kg if necessary | 0 | 10 | 0 | 10 | 10 | 10 |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA 9.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Palatal oedema | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Albumin urine present | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Beta 2 microglobulin urine increased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Corneal oedema | Eye disorders | MedDRA 9.1 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 9.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Application site erythema | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Postoperative fever | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Beta 2 microglobulin increased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pharyngolaryngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA 9.1 | Systematic Assessment |
|
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA 9.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 9.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Tooth socket haemorrhage | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Peripheral coldness | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Operative haemorrhage | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Joint warmth | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Musculoskeltal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Sputum retention | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pruritus genital | Reproductive system and breast disorders | MedDRA 9.1 | Systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
Any scientific paper, presentation, or other communication concerning the clinical trial described in the protocol will first be submitted to Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |