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.

Trial Health

100

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Feb 2003

Shorter than P25 for phase_3

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1 year study duration

Study Start

First participant enrolled

February 1, 2003

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed

5.5 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2009

Completed

1 month until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed

Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

1 year

First QC Date

July 23, 2009

Last Update Submit

April 16, 2015

Conditions

Anesthesia

Outcome Measures

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.
Day of Surgery, after injection of study drug until maximal depression of first twitch achieved

Secondary Outcomes (2)

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%

Study Arms (7)

Rocuronium 0.6 INT, 0.1 MNT

EXPERIMENTAL

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 doseDrug: Rocuronium 0.1 mg/kg maintenance dose

Rocuronium 0.6 INT, 0.15 MNT

EXPERIMENTAL

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 doseDrug: Rocuronium 0.15 mg/kg maintenance dose

Rocuronium 0.6 INT, 0.2 MNT

EXPERIMENTAL

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 doseDrug: Rocuronium 0.2 mg/kg maintenance

Rocuronium 0.9 INT, 0.1 MNT

EXPERIMENTAL

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 0.9 mg/kg intubating doseDrug: Rocuronium 0.1 mg/kg maintenance dose

Rocuronium 0.9 INT, 0.15 MNT

EXPERIMENTAL

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 0.9 mg/kg intubating doseDrug: Rocuronium 0.15 mg/kg maintenance dose

Rocuronium 0.9 INT, 0.2 MNT

EXPERIMENTAL

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 0.9 mg/kg intubating doseDrug: Rocuronium 0.2 mg/kg maintenance

Vecuronium 0.1 INT, 0.025 MNT

ACTIVE COMPARATOR

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 doseDrug: Vecuronium 0.025 mg/kg maintenance dose