Comparative Study of Rocuronium With Vecuronium (Study 71101)(COMPLETED)

Study Overview
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Brief Summary
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This study was conducted to determine and compare the safety and effectiveness of two neuromuscular blockers (rocuronium and vecuronium) at various doses in adults who are undergoing general elective surgery with sevoflurane anesthesia. Study participants received an intubating dose of a neuromuscular blocker (to enable insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation). The intubating dose was followed by repeated bolus maintenance doses as needed, to maintain muscle relaxation. The time it takes to reach maximal effect of the neuromuscular blocker (onset time) after the intubating dose was measured and compared as the primary outcome.

Detailed Description
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The TOF Watch-SX (acceleration transducer) was used in the measurement of neuromuscular blocking action.

Official Title
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Comparative Study of Org 9426 With Vecuronium Bromide (Phase III)

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Rocuronium 0.6 mg/kg intubating dose
* Drug: Rocuronium 0.9 mg/kg intubating dose
* Drug: Rocuronium 0.1 mg/kg maintenance dose
* Drug: Rocuronium 0.15 mg/kg maintenance dose
* Drug: Rocuronium 0.2 mg/kg maintenance
* Drug: Vecuronium 0.1 mg/kg intubating dose
* Drug: Vecuronium 0.025 mg/kg maintenance dose


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: at least 20 but under 65 years of age American Society of Anesthesiologists (ASA) Class 1, 2 or 3 for general elective surgery not considered to be pregnant scheduled for elective surgery under sevoflurane or propofol anesthesia with an anticipated duration of about 1.5-3 hours normal laboratory values Exclusion Criteria: certain medical conditions or medical histories receiving certain medications or treatments

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rocuronium 0.6 INT, 0.1 MNT<br>Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium. | Drug: Rocuronium 0.6 mg/kg intubating dose<br>* Rocuronium 0.6 mg/kg intubating dose<br>* Other names: Org 9426;Drug: Rocuronium 0.1 mg/kg maintenance dose<br>* Rocuronium 0.1 mg/kg maintenance dose following the intubating dose.<br>* Other names: Org 9426;|
| Experimental: Rocuronium 0.6 INT, 0.15 MNT<br>Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium. | Drug: Rocuronium 0.6 mg/kg intubating dose<br>* Rocuronium 0.6 mg/kg intubating dose<br>* Other names: Org 9426;Drug: Rocuronium 0.15 mg/kg maintenance dose<br>* Rocuronium 0.15 mg/kg maintenance dose following the intubating dose<br>* Other names: Org 9426;|
| Experimental: Rocuronium 0.6 INT, 0.2 MNT<br>Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium. | Drug: Rocuronium 0.6 mg/kg intubating dose<br>* Rocuronium 0.6 mg/kg intubating dose<br>* Other names: Org 9426;Drug: Rocuronium 0.2 mg/kg maintenance<br>* Rocuronium 0.2 mg/kg maintenance dose following the intubating dose<br>* Other names: Org 9426;|
| Experimental: Rocuronium 0.9 INT, 0.1 MNT<br>Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium. | Drug: Rocuronium 0.9 mg/kg intubating dose<br>* 0.9 mg/kg intubating dose of rocuronium<br>* Other names: Org 9426;Drug: Rocuronium 0.1 mg/kg maintenance dose<br>* Rocuronium 0.1 mg/kg maintenance dose following the intubating dose.<br>* Other names: Org 9426;|
| Experimental: Rocuronium 0.9 INT, 0.15 MNT<br>Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium. | Drug: Rocuronium 0.9 mg/kg intubating dose<br>* 0.9 mg/kg intubating dose of rocuronium<br>* Other names: Org 9426;Drug: Rocuronium 0.15 mg/kg maintenance dose<br>* Rocuronium 0.15 mg/kg maintenance dose following the intubating dose<br>* Other names: Org 9426;|
| Experimental: Rocuronium 0.9 INT, 0.2 MNT<br>Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium. | Drug: Rocuronium 0.9 mg/kg intubating dose<br>* 0.9 mg/kg intubating dose of rocuronium<br>* Other names: Org 9426;Drug: Rocuronium 0.2 mg/kg maintenance<br>* Rocuronium 0.2 mg/kg maintenance dose following the intubating dose<br>* Other names: Org 9426;|
| Active Comparator: Vecuronium 0.1 INT, 0.025 MNT<br>Participants in this group received a 0.1 mg/kg intubating dose of vecuronium followed by 0.025 mg/kg maintenance dose of vecuronium. | Drug: Vecuronium 0.1 mg/kg intubating dose<br>* Vecuronium 0.1 mg/kg intubating dose<br>* Other names: Norcuron;Drug: Vecuronium 0.025 mg/kg maintenance dose<br>* Vecuronium 0.025 mg/kg maintenance dose following the intubating dose<br>* Other names: Norcuron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset time of intubating dose. DESCRIPTION: The time interval between the completion of injection of the study drug (rocuronium or vecuronium) and the maximal depression of first twitch--measured via TOF Watch Sx(R)-- was defined as the onset time. |  | Day of Surgery, after injection of study drug until maximal depression of first twitch achieved | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects who achieved maximal block >=90% after the intubating dose. DESCRIPTION: Reaching a 90% depression of first twitch--measured via TOF Watch Sx(R)--was defined as achieving 90% block |  | Day of Surgery, after injection of study drug until maximal depression of first twice achieved | 
| Clinical duration after first maintenance dose. DESCRIPTION: The time interval between the completion of injection of study drug and return of first twitch to 25%(as measured by TOF Watch Sx(R)) was defined as the clinical duration. |  | Day of Surgery, after injection of study drug until return of first twitch to 25% |