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

Launched by MERCK SHARP & DOHME LLC · Jul 28, 2008

Keywords

ClinConnect Summary

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. in open abdominal procedures or during laparoscopic procedures in order to improve surgical conditions. Reversal with sugammadex at a dose of 4.0 mg.kg-1 at 1-2 PTC after an intubation dose of 0.6 mg.kg-1 or maintenance dosing rocuronium has been found to be both safe and efficacious in previous clinical trials but has never been investigated exclusively in participants undergoing laparoscopic...

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Eligibility 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