Status:
COMPLETED
Comparison of Rocuronium and Org 25969 With Cisatracurium and Neostigmine (19.4.310)(P05931)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Anesthesia, General
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 10 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2006
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00451100
Start Date
November 10 2005
End Date
August 29 2006
Last Update
November 15 2019
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