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

Phase 3

Completed

• Conditions: Anesthesia, General
• Interventions: Drug: Sugammadex; Drug: neostigmine

• Registration Number: NCT00451100
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-10
• Primary Completion: 2006-05-22
• Study Completion: 2006-08-29
• Study First Submitted: 2007-03-22
• Study First Submitted QC: 2007-03-22
• Study First Posted: 2007-03-23
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-13
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugammadex	Sugammadex	2.0 mg/kg Org 25969 (sugammadex)
Neostigmine	neostigmine	50 ug/kg neostigmine

Primary Outcome Measures

Name	Time	Method
Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.9	After surgery

Secondary Outcome Measures

Name	Time	Method
Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.7 and 0.8	After surgery
Assessment of clinical signs of recovery (level of consciousness, 5 sec head lift, and general muscle weakness)	after surgery