Skip to main content
OpenTrials
Completed

NCT Number: NCT00970762

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocuronium 0.6 mg/kg intubating dose

Drug

Rocuronium 0.6 mg/kg intubating dose

Other names: Zemuron, Org 9426

Rocuronium 0.9 mg/kg intubating dose

Drug

0.9 mg/kg intubating dose of rocuronium

Other names: Zemuron, Org 9426

Rocuronium 0.1 mg/kg maintenance dose

Drug

Rocuronium 0.1 mg/kg maintenance dose following the intubating dose.

Other names: Zemuron, Org 9426

Rocuronium 0.15 mg/kg maintenance dose

Drug

Rocuronium 0.15 mg/kg maintenance dose following the intubating dose

Other names: Zemuron, Org 9426

Rocuronium 0.2 mg/kg maintenance

Drug

Rocuronium 0.2 mg/kg maintenance dose following the intubating dose

Other names: Zemuron, Org 9426

Vecuronium 0.1 mg/kg intubating dose

Drug

Vecuronium 0.1 mg/kg intubating dose

Other names: Norcuron

Vecuronium 0.025 mg/kg maintenance dose

Drug

Vecuronium 0.025 mg/kg maintenance dose following the intubating dose

Other names: Norcuron

Primary outcomes

  1. 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.

    Time frame: Day of Surgery, after injection of study drug until maximal depression of first twitch achieved

Secondary outcomes

  1. 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

    Time frame: Day of Surgery, after injection of study drug until maximal depression of first twice achieved

  2. 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.

    Time frame: Day of Surgery, after injection of study drug until return of first twitch to 25%

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Sep 2, 2009
Registry last updated
Apr 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.