Comparison of Recovery From Rocuronium 1.2 mg/kg Followed By Org 25969 16 mg/kg at 3 Minutes With Recovery From Succinylcholine 1.0 mg/kg (19.4.303)(P05946)(COMPLETED)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anesthesia, General
Intervention: Sugammadex (Drug); succinylcholine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
Summary
The purpose of the trial is to demonstrate a faster recovery from neuromuscular block
induced by 1. 2 mg/kg ZemuronŽ 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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Recovery of T1 to 10% from start of rocuronium or succinylcholine administration
Secondary outcome: Recovery of T1 to 90% from start of rocuronium or succinylcholine administration and clinical signs of recovery (level of consciousness, 5-second head lift, general muscle weakness)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- ASA Class 1 or 2;
- 18 to 65 years of age (inclusive);
- Scheduled for elective surgical procedure under general anesthesia requiring a short
duration of neuromuscular block with the use of rocuronium or succinylcholine and
requiring endotracheal intubation;
- Scheduled for surgery in supine position;
- Body mass index (BMI) < 30;
- Given written informed consent.
Exclusion Criteria:
- Subjects with ischemic heart disease or history of myocardial infarction within the
last year;
- Subjects in whom a difficult intubation is expected due to anatomical malformations;
- Subjects known or suspected to have neuromuscular disorders impairing neuromuscular
blockade and/or significant renal dysfunction;
- Subjects known or suspected to have a (family) history of malignant hyperthermia;
- Subjects known or suspected to have an allergy to narcotics, muscle relaxants,
midazolam, anesthetics or other medications used during surgery;
- Subjects receiving medication known to interfere with neuromuscular blocking agents
such as anticonvulsants, antibiotics and Mg2+;
- Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
- Female subjects who are pregnant or breast-feeding;
- Females subjects of childbearing potential not using an acceptable method of birth
control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD,
abstinence];
- Subjects who had already participated in a Org 25969 trial including Protocol
19. 4.303;
Locations and Contacts
Additional Information
Starting date: February 2006
Last updated: June 5, 2015
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