A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971)

PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 20, 2005

Primary Completion Date

August 31, 2006

Study Completion Date

August 31, 2006

Conditions
Anesthesia, General
Interventions
DRUG

Sugammadex

"After induction of anesthesia an intubation dose of (Neuromuscular blocking agent) NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.~Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.~At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered"

DRUG

Placebo

"After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arm 1) or 0.1 mg/kg vecuronium (arm 6).~Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.~At reappearance of T2 the randomized single dose of Placebo IV was administered"

DRUG

Rocuronium

"After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV.~Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary."

DRUG

Vecuronium

After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV. Maintenance doses of 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00552617 - A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971) | Biotech Hunter | Biotech Hunter