Status:
COMPLETED
Dose-Finding Pediatric and Adult Trial With Sugammadex (Org 25969, MK-8616, SCH 900616) (19.4.306) (MK-8616-034) (P05961)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Anesthesia
Eligibility:
All Genders
28-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is: * to explore the dose-response relation of sugammadex (Org 25969, MK-8616, SCH 900616) given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in pe...
Eligibility Criteria
Inclusion
- American Society of Anesthesiologists (ASA) class 1 - 2, between the ages of 28 days and 65 years inclusive, and between the ages of 2 and 65 years inclusive for Germany and between the ages of 6 and 65 years inclusive for Finland
- Scheduled for general anesthesia with an anticipated duration of anesthesia of at least 60 minutes, without further need for muscle relaxation other than one single dose of 0.6 mg/kg rocuronium
- Scheduled for surgical procedures in the supine position
- Participants who, and/or whose parent(s) or legal guardian(s) have given written informed consent \[or appropriate assent, if applicable\]
Exclusion
- Known or suspected neuromuscular disorders impairing neuromuscular blockade (NMB) and/or significant renal dysfunction, in Germany creatinine and blood urea nitrogen outside local reference ranges
- Known or suspected to have a (family) history of malignant hyperthermia
- Known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
- Use of medication expected to interfere with the rocuronium given in this trial, based on the dose and the time of administration
- Pregnancy
- Childbearing potential not using any of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner (\>6 months), intrauterine device (IUD), abstinence
- Breast-feeding
- Prior participation in any study with Org 25969 (sugammadex)
- Participation in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into study 19.4.306 (MK-8616-034, P05961)
Key Trial Info
Start Date :
May 30 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2006
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00421148
Start Date
May 30 2005
End Date
June 2 2006
Last Update
January 28 2019
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