Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Participants Undergoing Short Surgical Procedures (19.4.319)(P05700 AM2)(COMPLETED)

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A multi-center, randomized, parallel group, comparative, active controlled, safety assessor blinded trial in adult subjects comparing rocuronium plus sugammadex versus succinylcholine alone in subjects undergoing short surgical procedures in out-patient surgicenters. The primary objective was to evaluate changes in plasma potassium levels after treatment with rocuronium, sugammadex, or succinylcholine in adult subjects scheduled for short surgical procedures in out-patient surgicenters.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• Male or female subjects >=18 years of age;

• ASA Class 1-3;

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

• Subjects scheduled to undergo an elective short procedure with general anesthesia requiring neuromuscular relaxation and endotracheal intubation in outpatient surgicenters;

• Subjects scheduled to undergo an elective surgical procedure expected to last 1.5 hours or less (from end of intubation to end of suturing/stapling of skin);

• Subjects who are scheduled to undergo an elective surgical procedures that allows access to the arm for TOF-Watch® SX monitoring;

• Subjects who have given written informed consent.

Exclusion Criteria:

• Subjects known to have ischemic heart disease or a history of myocardial infarction;

• Subjects in whom a difficult intubation is expected because of anatomical malformations;

• Subjects with medical conditions and/or undergoing surgical procedures that are not compatible with the use of the TOF-Watch SX (e.g., injuries to the thumbs/distal forearms, bilateral ulnar nerve damage or subjects with cardiac pacemakers);

• Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis);

• Subjects who would require the use of pneumatic tourniquet during the surgical procedure;

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

• Subjects known or suspected to have significant hepatic dysfunction;

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

• Subjects known or suspected to be hypersensitive to sugammadex or other cyclodextrins or rocuronium or any of its excipients;

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

• Subjects for whom a pre-established need for post operative intensive care admission and/or hospital admission is expected;

• Subjects for whom an intra operative IV administration of fluids that contain potassium is expected;

• Female subjects who are pregnant;

• Female subjects who are breast-feeding;

• Subjects who have participated in a previous sugammadex trial;

• Subjects who have participated in another investigational drug trial within 30 days before entering into clinical trial (CT) 19.4.319 (P05700) unless pre-approved by the sponsor.