Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Organon |
---|---|
Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00474253 |
The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced by 1.2 mg/kg Zemuron® after reversal at 3 minutes by 16.0 mg/kg of Org 25969 compared with recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.
Condition | Intervention | Phase |
---|---|---|
Anesthesia, General |
Drug: Sugammadex Drug: succinylcholine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Parallel Group, Comparative, Active-Controlled, Safety-Assessor Blinded, Phase IIIa, Trial, in Adult Subjects Comparing Recovery From 1.2 mg.kg-1 Rocuronium Followed by 16 mg.kg-1 Org 25969 at 3 Minutes With Recovery From 1.0 mg.kg-1 Succinylcholine |
Enrollment: | 115 |
Study Start Date: | February 2006 |
Study Completion Date: | August 2006 |
Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
rocuronium plus Org 25969
|
Drug: Sugammadex
Subjects were to receive an intubating dose of 1.2 mg/kg rocuronium followed by 16.0 mg/kg Org 25969 three minutes after the start of rocuronium administration.
|
2: Active Comparator
succinylcholine
|
Drug: succinylcholine
Subjects were to receive an intubation dose of 1.0 mg/kg succinylcholine and allowed to recovery spontaneously from neuromuscular blockade.
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | NV Organon, part of Schering-Plough Corporation ( Study Director ) |
Study ID Numbers: | 19.4.303 |
Study First Received: | May 15, 2007 |
Last Updated: | August 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00474253 |
Health Authority: | United States: Food and Drug Administration |
Succinylcholine Rocuronium |
Neuromuscular Nondepolarizing Agents Physiological Effects of Drugs Neuromuscular Depolarizing Agents Neuromuscular Agents |
Neuromuscular Blocking Agents Peripheral Nervous System Agents Pharmacologic Actions |