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

Condition(s) targeted: Anesthesia

Intervention: 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 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

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

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.

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

Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Starting date: February 2003
Last updated: April 16, 2015