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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970762
• Other study ID #: P05975
• Secondary ID: 71101
• Status: Completed
• Phase: Phase 3
• First received: July 23, 2009
• Last updated: April 16, 2015
• Start date: February 2003
• Est. completion date: February 2004

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Rocuronium 0.6 mg/kg intubating dose
Rocuronium 0.6 mg/kg intubating dose
• Rocuronium 0.9 mg/kg intubating dose
0.9 mg/kg intubating dose of rocuronium
• Rocuronium 0.1 mg/kg maintenance dose
Rocuronium 0.1 mg/kg maintenance dose following the intubating dose.
• Rocuronium 0.15 mg/kg maintenance dose
Rocuronium 0.15 mg/kg maintenance dose following the intubating dose
• Rocuronium 0.2 mg/kg maintenance
Rocuronium 0.2 mg/kg maintenance dose following the intubating dose
• Vecuronium 0.1 mg/kg intubating dose
Vecuronium 0.1 mg/kg intubating dose
• Vecuronium 0.025 mg/kg maintenance dose
Vecuronium 0.025 mg/kg maintenance dose following the intubating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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%	No