Status:
COMPLETED
Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Anesthesia, General
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the optimal dose of sugammadex when this compound is administered during deep neuromuscular block. Sugammadex is administered shortly (5 minutes) after admini...
Eligibility Criteria
Inclusion
- ASA 1 - 2 between the ages of 18 and 64, inclusive
- Scheduled for surgical procedures with an anticipated duration of anesthesia of at least 90 minutes, without further need for muscle relaxation other than for intubation
- Scheduled for surgery 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 known to interfere with neuromuscular blocking agents such as anticonvulsants and Mg2+
- Subjects who had already participated in CT 19.4.205
- Subjects who had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into CT 19.4.205
- Female subjects who are pregnant: in females pregnancy was to be excluded both from medical history and by an hCG test within 24 hours before surgery except in females who were not of childbearing potential i.e. at least 2 years postmenopausal or underwent tubal ligation or an hysterectomy
- Females of childbearing potential not using an acceptable method of birth control: condom or diaphragm with spermicide, vasectomized partner (\>6 months), IUD, abstinence
- Subjects giving breast-feeding
Key Trial Info
Start Date :
November 7 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2004
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00379613
Start Date
November 7 2003
End Date
July 14 2004
Last Update
August 22 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.