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

NCT ID: NCT00751179

Last Updated: 2015-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-12-31

Brief 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.

Conditions

Neuromuscular Blockade

Study Design

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

Study Groups

Rocuronium - Sugammadex

Rocuronium - Sugammadex 4.0 mg/kg

Group Type: ACTIVE_COMPARATOR

rocuronium

Intervention Type: DRUG

A single bolus intubation dose of 0.6 mg/kg rocuronium will be administered following induction of anesthesia and if required, single bolus dose(s) of 0.15 mg/kg rocuronium will be administered to maintain the neuromuscular block.

sugammadex

Intervention Type: DRUG

At the end of the surgical procedure at a target depth of neuromuscular blockade of at least 1-2 Post-Tetanic Count (PTC), 4.0 mg/kg of sugammadex will be administered.

Succinylcholine

Succinylcholine 1.0 mg/kg

Group Type: ACTIVE_COMPARATOR

succinylcholine

Intervention Type: DRUG

A single bolus intubation dose of 1.0 mg/kg succinylcholine will be administered following induction of anesthesia and the subject is allowed to recover spontaneously from the neuromuscular blockade.

Interventions

rocuronium

A single bolus intubation dose of 0.6 mg/kg rocuronium will be administered following induction of anesthesia and if required, single bolus dose(s) of 0.15 mg/kg rocuronium will be administered to maintain the neuromuscular block.

Intervention Type: DRUG

sugammadex

At the end of the surgical procedure at a target depth of neuromuscular blockade of at least 1-2 Post-Tetanic Count (PTC), 4.0 mg/kg of sugammadex will be administered.

Intervention Type: DRUG

succinylcholine

A single bolus intubation dose of 1.0 mg/kg succinylcholine will be administered following induction of anesthesia and the subject is allowed to recover spontaneously from the neuromuscular blockade.

Intervention Type: DRUG

Other Intervention Names

Zemuron® Injection (rocuronium bromide); sugammadex sodium injection; SCH 900916; Org 25969; Bridion; Quelicin® (succinylcholine chloride injection United States Pharmacopeia [USP])

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Soto R, Jahr JS, Pavlin J, Sabo D, Philip BK, Egan TD, Rowe E, de Bie J, Woo T. Safety and Efficacy of Rocuronium With Sugammadex Reversal Versus Succinylcholine in Outpatient Surgery-A Multicenter, Randomized, Safety Assessor-Blinded Trial. Am J Ther. 2016 Nov/Dec;23(6):e1654-e1662. doi: 10.1097/MJT.0000000000000206.

Reference Type: RESULT

PMID: 25768376 (View on PubMed)

Sabo D, Jahr J, Pavlin J, Philip B, Shimode N, Rowe E, Woo T, Soto R. The increases in potassium concentrations are greater with succinylcholine than with rocuronium-sugammadex in outpatient surgery: a randomized, multicentre trial. Can J Anaesth. 2014 May;61(5):423-32. doi: 10.1007/s12630-014-0128-7. Epub 2014 Apr 8.

Reference Type: DERIVED

PMID: 24710957 (View on PubMed)

Other Identifiers

19.4.319

Identifier Type: -

Identifier Source: secondary_id

P05700

Identifier Type: -

Identifier Source: org_study_id