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

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Rocuronium 0.6 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: Rocuronium 0.9 mg/kg intubating dose; Drug: Vecuronium 0.1 mg/kg intubating dose; Drug: Vecuronium 0.025 mg/kg maintenance dose

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rocuronium 0.6 INT, 0.1 MNT; 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; Rocuronium 0.6 mg/kg intubating dose; Other Names: Zemuron; Org 9426; Drug: Rocuronium 0.1 mg/kg maintenance dose; Rocuronium 0.1 mg/kg maintenance dose following the intubating dose.; Other Names: Zemuron; Org 9426
Experimental: Rocuronium 0.6 INT, 0.15 MNT; 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; Rocuronium 0.6 mg/kg intubating dose; Other Names: Zemuron; Org 9426; Drug: Rocuronium 0.15 mg/kg maintenance dose; Rocuronium 0.15 mg/kg maintenance dose following the intubating dose; Other Names: Zemuron; Org 9426
Experimental: Rocuronium 0.6 INT, 0.2 MNT; 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; Rocuronium 0.6 mg/kg intubating dose; Other Names: Zemuron; Org 9426; Drug: Rocuronium 0.2 mg/kg maintenance; Rocuronium 0.2 mg/kg maintenance dose following the intubating dose; Other Names: Zemuron; Org 9426
Experimental: Rocuronium 0.9 INT, 0.1 MNT; 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 0.1 mg/kg maintenance dose; Rocuronium 0.1 mg/kg maintenance dose following the intubating dose.; Other Names: Zemuron; Org 9426; Drug: Rocuronium 0.9 mg/kg intubating dose; 0.9 mg/kg intubating dose of rocuronium; Other Names: Zemuron; Org 9426
Experimental: Rocuronium 0.9 INT, 0.15 MNT; 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 0.15 mg/kg maintenance dose; Rocuronium 0.15 mg/kg maintenance dose following the intubating dose; Other Names: Zemuron; Org 9426; Drug: Rocuronium 0.9 mg/kg intubating dose; 0.9 mg/kg intubating dose of rocuronium; Other Names: Zemuron; Org 9426
Experimental: Rocuronium 0.9 INT, 0.2 MNT; 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 0.2 mg/kg maintenance; Rocuronium 0.2 mg/kg maintenance dose following the intubating dose; Other Names: Zemuron; Org 9426; Drug: Rocuronium 0.9 mg/kg intubating dose; 0.9 mg/kg intubating dose of rocuronium; Other Names: Zemuron; Org 9426
Active Comparator: Vecuronium 0.1 INT, 0.025 MNT; 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; Vecuronium 0.1 mg/kg intubating dose; Other Names: Norcuron; Drug: Vecuronium 0.025 mg/kg maintenance dose; Vecuronium 0.025 mg/kg maintenance dose following the intubating dose; Other Names: Norcuron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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%

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2003
• Primary Completion (Actual): February 1, 2004
• Study Completion (Actual): February 1, 2004

Study Registration Dates

• First Submitted: July 23, 2009
• First Submitted That Met QC Criteria: September 1, 2009
• First Posted (Estimate): September 2, 2009

Study Record Updates

• Last Update Posted (Estimate): April 17, 2015
• Last Update Submitted That Met QC Criteria: April 16, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Neuromuscular Agents; Nicotinic Antagonists; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium; Vecuronium Bromide
• Other Study ID Numbers: P05975; 71101