Status:
COMPLETED
Comparison of Sugammadex (Org 25969) With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (P05960)
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 participants faster recovery from a neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance of T2 (the ampli...
Eligibility Criteria
Inclusion
- Is of American Society of Anesthesiologists (ASA) 1 - 4;
- Is above or equal to the age of 18;
- Scheduled for surgical procedures with a general anesthesia with the use of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block;
- Scheduled for surgical procedure in supine position;
- Given written informed consent.
Exclusion
- Participants in whom a difficult intubation because of anatomical malformations was expected;
- Is known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) and/or significant renal dysfunction;
- Is known or suspected to have a (family) history of malignant hyperthermia;
- Is known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
- Is receiving medication in a dose and/or at a time point known to interfere with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+;
- Participants in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
- Had already participated in a sugammadex trial;
- Had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into P05960.
- Females who are pregnant:
- Females of childbearing potential not using any method of birth control: condom or using only hormonal contraception as birth control;
- Females who were breast-feeding.
Key Trial Info
Start Date :
November 17 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2006
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00451217
Start Date
November 17 2005
End Date
March 6 2006
Last Update
March 4 2019
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