DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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.


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)


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017