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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Neuromuscular Blockade

Treatments: Drug: rocuronium; Drug: sugammadex; Drug: succinylcholine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00751179

P05700

19.4.319

Details and patient eligibility

About

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.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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161 participants in 2 patient groups

Rocuronium - Sugammadex

Active Comparator group

Description:

Rocuronium - Sugammadex 4.0 mg/kg

Treatment:

Drug: sugammadex

Drug: rocuronium

Succinylcholine

Active Comparator group

Description:

Succinylcholine 1.0 mg/kg

Treatment:

Drug: succinylcholine