Clinical trial NCT00751179: Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Participants Undergoing Short Surgical Procedures (19.4.319)(P05700 AM2)(COMPLETED)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuromuscular Blockade
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-09-11
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Rocuronium or Succinylcholine
timeFrame: Baseline and 5 minutes post dose
measure: Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Sugammadex
timeFrame: Baseline and 5 minutes post dose
Secondary outcomes:
measure: Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Rocuronium or Succinylcholine
timeFrame: Baseline and 2 minutes post dose
measure: Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Sugammadex
timeFrame: Baseline and 2 minutes post dose
measure: Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Rocuronium or Succinylcholine
timeFrame: Baseline and 10 minutes post dose
measure: Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Sugammadex
timeFrame: Baseline and 10 minutes post dose
measure: Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Rocuronium or Succinylcholine
timeFrame: Baseline and 15 minutes post dose
measure: Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Sugammadex
timeFrame: Baseline and 15 minutes post dose
measure: Number of Participants With at Least One Adverse Event (AE) in Rocuronium - Sugammadex and Succinylcholine Treatment Groups
timeFrame: Up to 7 days post dose
measure: Time to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 Following Administration of 4.0 mg/kg of Sugammadex After Neuromuscular Blockade Induced by Rocuronium
timeFrame: Start of administration of sugammadex to recovery from neuromuscular blockade (Up to approximately 6 minutes)
measure: Time to Recovery of T1 to 90% of Baseline Following Neuromuscular Blockade Induced by Succinylcholine
timeFrame: Start of administration of succinylcholine to recovery from neuromuscular blockade (Up to approximately 18 minutes)
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.