Status:
COMPLETED
Comparison of Sugammadex With Neostigmine During Laparoscopic Cholecystectomy or Appendectomy (P05699)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Anesthesia, General
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The current trial was designed to demonstrate faster recovery from a neuromuscular blockade (NMB) induced by rocuronium after reversal at 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 sugammadex compare...
Detailed Description
In those surgical procedures where a neuromuscular block is desired for intubation and/or avoid unwanted muscular activity, anesthesiologists may use a more profound NMB until the end of surgery, e.g....
Eligibility Criteria
Inclusion
- Participants of American Society of Anesthesiologists class 1-3
- Participants of age above or equal to the age of 18 years
- Participants who are scheduled to undergo a laparoscopic cholecystectomy or appendectomy under general anesthesia requiring neuromuscular relaxation with rocuronium, and if applicable, maintenance of neuromuscular blockade
- Participants who have given written informed consent
Exclusion
- Participants in whom a difficult intubation because of anatomical malformations is expected
- Participants known or suspected to have neuromuscular disorders affecting NMB
- Participants known or suspected to have a significant renal dysfunction
- Participants known or suspected to have a severe hepatic dysfunction
- Participants known or suspected to have (family) history of malignant hyperthermia
- Participants known or suspected to have an allergy to opioids, muscle relaxants or other medication used during general anesthesia
- Participants in whom the use of neostigmine and/or atropine is contraindicated
- Female participants who are pregnant (pregnancy will be excluded for women both from medical history and by a human chorionic gonadotropin (hCG) test within 24h before surgery, except for women who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or a hysterectomy)
- Female participants who are breast-feeding
- Participants who participated in another clinical trial not pre-approved by the sponsor, within 30 days of entering into trial 19.4.318 (P05699)
- Participants who have already participated in a sugammadex trial
Key Trial Info
Start Date :
July 16 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2009
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00724932
Start Date
July 16 2008
End Date
May 3 2009
Last Update
May 16 2017
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