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| ID | Type | Description | Link |
|---|---|---|---|
| 21048 |
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The primary purpose of this study is to determine the dose requirements of rocuronium bromide when administered as a bolus dose (a single, large dose) for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) and when administered by either continuous infusion or bolus doses for maintenance of muscle relaxation in term neonates (birth to <28 days old), infants (28 days to <=3 months) and toddlers (>3 months to <=2 years), children (2 years to less than or equal to 11 years of age), and adolescents (>11 years to less than or equal to 17 years of age).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rocuronium bolus maintenance | Experimental | Rocuronium bolus maintenance |
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| Rocuronium continuous infusion maintenance | Experimental | Rocuronium continuous infusion maintenance |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium bolus maintenance | Drug | Subjects received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation |
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| Measure | Description | Time Frame |
|---|---|---|
| Total Dose of Zemuron (Rocuronium) Administered | Total dose from administration of intubating dose to reappearance of T3 (the third twitch of a Train of Four [TOF] stimulation) after the last maintenance bolus dose or discontinuation of Zemuron (rocuronium) infusion (Per protocol [PP] data set) | during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70% | The time it takes for the the T4 to T1 ratio to reach 70%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%). | after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Bhattacharya ST, Jeffrey Koh J, Martin L, Suresh S, Frietsch T. Randomized, Multicenter Trial of Rocuronium in Neonates, Infants, Toddlers, Children & Adolescents [abstract]. Anesthesiology. 2009;111(5):A841. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rocuronium Bolus Maintenance - Neonate (BN) | Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation |
| FG001 | Rocuronium Bolus Maintenance - Infants (BI) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| rocuronium continuous infusion maintenance | Drug | Subjects received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
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| Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80% | The time it takes for the the T4 to T1 ratio to reach 80%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%). | after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium) |
| Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90% | The time it takes for the the T4 to T1 ratio to reach 90%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%). | after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium) |
Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
| FG002 | Rocuronium Bolus Maintenance - Toddlers (BT) | Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation |
| FG003 | Rocuronium Bolus Maintenance -Children (BC) | Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation |
| FG004 | Rocuronium Bolus Maintenance - Adolescents (BA) | Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation |
| FG005 | Rocuronium Continuous Infusion Maintenance - Neonates (IN) | Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| FG006 | Rocuronium Continuous Infusion Maintenance - Infants (II) | Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| FG007 | Rocuronium Continuous Infusion Maintenance - Toddlers (IT) | Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| FG008 | Rocuronium Continuous Infusion Maintenance - Children (IC) | Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| FG009 | Rocuronium Continuous Infusion Maintenance - Adolescents (IA) | Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rocuronium Bolus Maintenance - Neonate (BN) | Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation |
| BG001 | Rocuronium Bolus Maintenance - Infants (BI) | Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation |
| BG002 | Rocuronium Bolus Maintenance - Toddlers (BT) | Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation |
| BG003 | Rocuronium Bolus Maintenance -Children (BC) | Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation |
| BG004 | Rocuronium Bolus Maintenance - Adolescents (BA) | Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation |
| BG005 | Rocuronium Continuous Infusion Maintenance - Neonates (IN) | Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| BG006 | Rocuronium Continuous Infusion Maintenance - Infants (II) | Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| BG007 | Rocuronium Continuous Infusion Maintenance - Toddlers (IT) | Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| BG008 | Rocuronium Continuous Infusion Maintenance - Children (IC) | Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| BG009 | Rocuronium Continuous Infusion Maintenance - Adolescents (IA) | Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| BG010 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Total of 137 subjects include all subjects who received rocuronium | Count of Participants | Participants |
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| Sex: Female, Male | Total of 137 subjects include all subjects who received rocuronium | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Total Dose of Zemuron (Rocuronium) Administered | Total dose from administration of intubating dose to reappearance of T3 (the third twitch of a Train of Four [TOF] stimulation) after the last maintenance bolus dose or discontinuation of Zemuron (rocuronium) infusion (Per protocol [PP] data set) | Per protocol population | Posted | Mean | Standard Deviation | mg/kg | during surgery |
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| Secondary | Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70% | The time it takes for the the T4 to T1 ratio to reach 70%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%). | per-protocol population | Posted | Mean | Standard Deviation | minutes | after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium) |
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| Secondary | Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80% | The time it takes for the the T4 to T1 ratio to reach 80%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%). | per-protocol population | Posted | Mean | Standard Deviation | minutes | after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium) |
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| Secondary | Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90% | The time it takes for the the T4 to T1 ratio to reach 90%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%). | per-protocol population | Posted | Mean | Standard Deviation | minutes | after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium) |
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All subjects who received rocuronium were included in the safety analyses.
Information regarding adverse events were obtained by questioning or examining the subject. At each visit during the treatment period, all new complaints and symptoms were recorded.
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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 | Rocuronium Bolus Maintenance | Subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents). | 1 | 64 | 10 | 64 | ||
| EG001 | Rocuronium Continuous Infusion Maintenance | Subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents) | 0 | 73 | 9 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| postoperative wound infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| procedural pain | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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Any scientific paper, presentation, or other communication concerning the clinical trial described in the protocol will first be submitted to Organon, at least 6 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. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation |
| OG004 | Rocuronium Bolus Maintenance - Adolescents (BA) | Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation |
| OG005 | Rocuronium Continuous Infusion Maintenance - Neonates (IN) | Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| OG006 | Rocuronium Continuous Infusion Maintenance - Infants (II) | Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| OG007 | Rocuronium Continuous Infusion Maintenance - Toddlers (IT) | Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| OG008 | Rocuronium Continuous Infusion Maintenance - Children (IC) | Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| OG009 | Rocuronium Continuous Infusion Maintenance - Adolescents (IA) | Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
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Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation |
| OG004 | Rocuronium Bolus Maintenance - Adolescents (BA) | Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation |
| OG005 | Rocuronium Continuous Infusion Maintenance - Neonates (IN) | Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| OG006 | Rocuronium Continuous Infusion Maintenance - Infants (II) | Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| OG007 | Rocuronium Continuous Infusion Maintenance - Toddlers (IT) | Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| OG008 | Rocuronium Continuous Infusion Maintenance - Children (IC) | Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| OG009 | Rocuronium Continuous Infusion Maintenance - Adolescents (IA) | Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
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Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation |
| OG004 | Rocuronium Bolus Maintenance - Adolescents (BA) | Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation |
| OG005 | Rocuronium Continuous Infusion Maintenance - Neonates (IN) | Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| OG006 | Rocuronium Continuous Infusion Maintenance - Infants (II) | Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| OG007 | Rocuronium Continuous Infusion Maintenance - Toddlers (IT) | Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| OG008 | Rocuronium Continuous Infusion Maintenance - Children (IC) | Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
| OG009 | Rocuronium Continuous Infusion Maintenance - Adolescents (IA) | Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation |
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