Phase 3 Completed N=161 Randomized Single-blind Treatment

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

Neuromuscular blockade

Source: ClinicalTrials.gov NCT00751179 ↗

Enrolled (actual)

161

Serious AEs

2.7%

Results posted

Mar 2012

Primary outcomePrimary: Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Rocuronium or Succinylcholine — -0.06; 0.30 mmol/L — p=<0.0001

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Rocuronium or Succinylcholine	-0.06; 0.30	<0.0001 sig
PRIMARY Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Sugammadex	0.02	—
SECONDARY Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Rocuronium or Succinylcholine	-0.09; 0.19	<0.0001 sig
SECONDARY Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Sugammadex	-0.02	—
SECONDARY Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Rocuronium or Succinylcholine	-0.01; 0.32	<0.0001 sig
SECONDARY Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Sugammadex	0.07	—
SECONDARY Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Rocuronium or Succinylcholine	0.02; 0.33	<0.0001 sig
SECONDARY Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Sugammadex	0.07	—
SECONDARY Number of Participants With at Least One Adverse Event (AE) in Rocuronium - Sugammadex and Succinylcholine Treatment Groups	60; 75	—
SECONDARY 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	1.79	—
SECONDARY Time to Recovery of T1 to 90% of Baseline Following Neuromuscular Blockade Induced by Succinylcholine	10.76	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00751179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.