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)

NCT ID: NCT00675792

Last Updated: 2015-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-09-30

Brief 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.

Detailed 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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sugammadex

4 mg/kg sugammadex

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Participants received 4 mg/kg sugammadex at 1-2 Post Tetanic Counts (PTCs) or better after the last dose of rocuronium bromide.

Rocuronium

Intervention Type: DRUG

Participants received a single intubation bolus dose of 0.6 mg/kg rocuronium bromide, followed if necessary to maintain neuromuscular blockade by one or more single bolus dose(s) of 0.15 mg/kg rocuronium bromide.

Neostigmine

50 µg/kg neostigmine

Group Type: ACTIVE_COMPARATOR

Neostigmine

Intervention Type: DRUG

Participants received 50 µg/kg neostigmine combined with 10 µg/kg glycopyrrolate after the last dose of rocuronium bromide as per standard of care.

Rocuronium

Intervention Type: DRUG

Participants received a single intubation bolus dose of 0.6 mg/kg rocuronium bromide, followed if necessary to maintain neuromuscular blockade by one or more single bolus dose(s) of 0.15 mg/kg rocuronium bromide.

Interventions

Sugammadex

Participants received 4 mg/kg sugammadex at 1-2 Post Tetanic Counts (PTCs) or better after the last dose of rocuronium bromide.

Intervention Type: DRUG

Neostigmine

Participants received 50 µg/kg neostigmine combined with 10 µg/kg glycopyrrolate after the last dose of rocuronium bromide as per standard of care.

Intervention Type: DRUG

Rocuronium

Participants received a single intubation bolus dose of 0.6 mg/kg rocuronium bromide, followed if necessary to maintain neuromuscular blockade by one or more single bolus dose(s) of 0.15 mg/kg rocuronium bromide.

Intervention Type: DRUG

Other Intervention Names

Org 25969; SCH 900616; MK-8616; Bridion®; Prostigmin®; Rocuronium bromide; Esmeron®

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Sabo D, Jones RK, Berry J, Sloan T, Chen J-Y, Morte JB, Groudine S. Residual neuromuscular blockade at extubation: a randomized comparison of sugammadex and neostigmine reversal of rocuronium-induced blockade in patients undergoing abdominal surgery. J Anesthe Clin Res. 2011;2:140.

Reference Type: RESULT

Other Identifiers

19.4.334

Identifier Type: OTHER

Identifier Source: secondary_id

P05774

Identifier Type: -

Identifier Source: org_study_id