Comparison of Sugammadex With Neostigmine During Laparoscopic Cholecystectomy or Appendectomy (P05699)

• Status: Completed
• Trial end date: 2009-05-03
• Target enrollment: 0
• Participant gender: All

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 compared to 50 µg.kg-1 neostigmine at reappearance of second twitch (T2) in participants undergoing laparoscopic cholecystectomy or appendectomy under propofol anesthesia, to compare safety and to evaluate operating room and Post Anesthetic Care Unit (PACU) length of stay.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Atropine; Bromides; Neostigmine; Rocuronium

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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