Phase 3
Completed N=161
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.
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.