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 (19.4.334) (P05774)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Anesthesia

Treatments: Drug: Neostigmine; Drug: Sugammadex; Drug: Rocuronium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00675792

19.4.334 (Other Identifier)

P05774

Details and patient eligibility

About

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.

Full description

Undetected residual neuromuscular blockade is common in the post-anesthesia care

unit (PACU). In fact, 16%-42% of patients receiving intermediate-acting muscle

relaxants in the operating room have T4/T1 ratios <0.7-0.8 in the PACU. Respiratory and pharyngeal muscle function can be adversely affected during minimal neuromuscular blockade. Studies in awake volunteers and surgical patients have demonstrated that T4/T1 ratios of 0.7 - 0.9 are associated with impaired airway protective reflexes, upper airway obstruction, a decreased hypoxic ventilatory response, and post-operative hypoxemia. The incidence and severity of residual neuromuscular blockade at the time of tracheal extubation will be evaluated to determine how these influence the length of stay in the operating room and PACU.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Sugammadex

Experimental group

Description:

4 mg/kg sugammadex

Treatment:

Drug: Rocuronium

Drug: Sugammadex

Neostigmine

Active Comparator group

Description:

50 µg/kg neostigmine

Treatment:

Drug: Rocuronium

Drug: Neostigmine