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

NCT00751179 | Completed Phase 3 Results

• 2 other identifiers: P0570019.4.319
• Study Type: interventional
• Target: 161
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Rocuronium or Succinylcholine

  Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).

  Baseline and 5 minutes post dose

• Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Sugammadex

  Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).

  Baseline and 5 minutes post dose

Secondary Outcomes (9)

• Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Rocuronium or Succinylcholine

  Baseline and 2 minutes post dose

• Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Sugammadex

  Baseline and 2 minutes post dose

• Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Rocuronium or Succinylcholine

  Baseline and 10 minutes post dose

• Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Sugammadex

  Baseline and 10 minutes post dose

• Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Rocuronium or Succinylcholine

  Baseline and 15 minutes post dose

Study Arms (2)

Rocuronium - Sugammadex

ACTIVE COMPARATOR

Rocuronium - Sugammadex 4.0 mg/kg

Drug: rocuronium; Drug: sugammadex

Succinylcholine

ACTIVE COMPARATOR

Succinylcholine 1.0 mg/kg

Drug: succinylcholine

Interventions

rocuronium 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.

Also known as: Zemuron® Injection (rocuronium bromide)

Rocuronium - Sugammadex

sugammadex 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.

Also known as: sugammadex sodium injection, SCH 900916, Org 25969, Bridion

Rocuronium - Sugammadex

succinylcholine 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.

Also known as: Quelicin® (succinylcholine chloride injection United States Pharmacopeia [USP])

Succinylcholine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (2)

• 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.

  PMID: 25768376 RESULT

• 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.

  PMID: 24710957 DERIVED

MeSH Terms

Interventions

Rocuronium; Sugammadex; Succinylcholine

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds

Limitations and Caveats

The potassium change from baseline interval included most/all of the intubation/surgical period for the sug but not the suc or roc analysis. AE reporting interval included the entire intubation/surgery period for the suc but not the roc-sug group.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2008
• First Posted: September 11, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 30, 2015
• Results First Posted: March 20, 2012

Record last verified: 2015-06