Comparison of Rocuronium and Org 25969 With Cisatracurium and Neostigmine (19.4.310)(P05931)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Anesthesia, General

Treatments

Drug: neostigmine

Drug: Sugammadex

Study type

Interventional

Funder types

Industry

Identifiers

NCT00451100

Crystal Trial

P05931

19.4.310

Details and patient eligibility

About

The purpose of this study was to demonstrate in adult patients a faster recovery from a neuromuscular block with 2.0 mg/kg Org 25969 (sugammadex) after rocuronium as compared to 50 ug/kg neostigmine after cisatracurium when administered at reappearance of T2

Enrollment

84 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects of ASA 1 - 4;
Subjects above or equal to the age of 18;
Scheduled for surgical procedures with a general anesthesia requiring neuromuscular relaxation with the use of rocuronium or cisatracurium;
Scheduled for surgical procedures in supine position;
Given written informed consent.

Exclusion criteria

Subjects in whom a difficult intubation because of anatomical malformations was expected;
Subjects known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) 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 or other medication used during general anesthesia;
Subjects receiving medication in a dose and/or at a time point known to interfere with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+;
Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
Subjects who had already participated in an Org25969 trial;
Subjects who had participated in another clinical trial (not pre-approved by NV Organon) within 30 days of entering into CT 19.4.310.
Female subjects who are pregnant:
Female subjects of childbearing potential not using any method of birth control: condom or using only hormonal contraception as birth control;
Female subjects who were breast -feeding.