Comparison of Sugammadex Administered at 1-2 Post Tetanic Counts (PTCs) or Better With Neostigmine Administered as Per Standard of Care to Reverse Rocuronium-Induced Neuromuscular Blockade in Adults Undergoing Elective Open Abdominal Procedure (19.4

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to compare the incidence of

residual neuromuscular blockade at the time of tracheal extubation after reversal of rocuronium bromide-induced neuromuscular blockade by 4 mg/kg sugammadex with that of 50 µg/kg neostigmine. Residual neuromuscular blockade is defined as the fourth twitch to first twitch (T4/T1) ratio of

< 0.90.

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

Details

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

Criteria

Inclusion Criteria:

• male or females who are >= 18 and <= 65 years of age

• classified by the American Society of Anesthesiologists (ASA) as Class 1 or 2 or 3;

• Body Mass Index (BMI) of <35 kg/m^2;

• is scheduled to undergo an elective open abdominal surgical procedure under general anesthesia requiring neuromuscular relaxation using rocuronium bromide (maintenance of neuromuscular blockade if required) for endotracheal intubation and requiring neuromuscular blockade reversal;

• is scheduled to undergo a surgical procedure in a position that does not interfere with the use of TOF-Watch® SX;

• is scheduled to undergo an elective open abdominal procedure expected to last <=4 hours (from start of skin incision to end of last stitch of the skin);

• have given written informed consent.

Exclusion Criteria:

• participants for whom a difficult intubation is expected because of anatomical malformations;

• is known or suspected to have neuromuscular disorders that may impair neuromuscular blockade;

• is known or suspected to have significant renal dysfunction (e.g., creatinine clearance < 30 mL/min) ;

• is known or suspected to have significant hepatic dysfunction;

• is known or suspected to have a (family) history of malignant hyperthermia;

• is known or suspected to have an allergy to opioids, muscle relaxants or other medications used during general anesthesia;

• participants for whom the use of neostigmine and/or glycopyrrolate may be contraindicated;

• participants for whom a pre-established need for postoperative intensive care admission is expected;

• pregnant or breast-feeding females;

• have participated in a previous sugammadex clinical trial;