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

Phase 3

Completed

• Conditions: Anesthesia
• Interventions: Drug: Vecuronium 0.1 mg/kg intubating dose; Drug: Rocuronium 0.6 mg/kg intubating dose; Drug: Rocuronium 0.9 mg/kg intubating dose; Drug: Vecuronium 0.025 mg/kg maintenance dose; Drug: Rocuronium 0.1 mg/kg maintenance dose; Drug: Rocuronium 0.2 mg/kg maintenance; Drug: Rocuronium 0.15 mg/kg maintenance dose

• Registration Number: NCT00970762
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

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

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

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Exclusion Criteria

• certain medical conditions or medical histories
• receiving certain medications or treatments

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vecuronium 0.1 INT, 0.025 MNT	Vecuronium 0.1 mg/kg intubating dose	Participants in this group received a 0.1 mg/kg intubating dose of vecuronium followed by 0.025 mg/kg maintenance dose of vecuronium.
Vecuronium 0.1 INT, 0.025 MNT	Vecuronium 0.025 mg/kg maintenance dose	Participants in this group received a 0.1 mg/kg intubating dose of vecuronium followed by 0.025 mg/kg maintenance dose of vecuronium.
Rocuronium 0.6 INT, 0.2 MNT	Rocuronium 0.6 mg/kg intubating dose	Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium.
Rocuronium 0.9 INT, 0.15 MNT	Rocuronium 0.9 mg/kg intubating dose	Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium.
Rocuronium 0.6 INT, 0.1 MNT	Rocuronium 0.1 mg/kg maintenance dose	Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium.
Rocuronium 0.9 INT, 0.2 MNT	Rocuronium 0.2 mg/kg maintenance	Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium.
Rocuronium 0.9 INT, 0.1 MNT	Rocuronium 0.1 mg/kg maintenance dose	Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium.
Rocuronium 0.9 INT, 0.15 MNT	Rocuronium 0.15 mg/kg maintenance dose	Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium.
Rocuronium 0.6 INT, 0.2 MNT	Rocuronium 0.2 mg/kg maintenance	Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium.
Rocuronium 0.6 INT, 0.15 MNT	Rocuronium 0.15 mg/kg maintenance dose	Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium.
Rocuronium 0.6 INT, 0.15 MNT	Rocuronium 0.6 mg/kg intubating dose	Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium.
Rocuronium 0.9 INT, 0.1 MNT	Rocuronium 0.9 mg/kg intubating dose	Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium.
Rocuronium 0.9 INT, 0.2 MNT	Rocuronium 0.9 mg/kg intubating dose	Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium.
Rocuronium 0.6 INT, 0.1 MNT	Rocuronium 0.6 mg/kg intubating dose	Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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%