Comparison of sugammadex dosed according to total (TBW) and correctedbody weight (CBW) for reversal of rocuronium-induced neuromuscularblockade in morbidly obese patients undergoing laparoscopic bariatricsurgery. A double-blind, randomized controlled trial.
- Conditions
- Reversal of rocuronium-induced neuromuscular blockadeMedDRA version: 18.0Level: PTClassification code 10057286Term: Neuromuscular blockade reversalSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Health Care [N] - Health Services Administration [N04]
- Registration Number
- EUCTR2014-005052-25-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI PADOVA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 204
age over 18 years;
• morbid obesity class II (with comorbidities), and class III;
• patients undergoing surgery for laparoscopic bariatric surgery
• presence of neuromuscular monitoring (TOF Watch SX®)
• presence of moderate NMB (T1-T2 TOF) or deep NMB (absence of T1 TOF) at reversal
• preoperative coagulation parameters within normal limits
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 204
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• obesity class I and II (in the absence of co-morbidities);
• muscle dysfunction (eg. Myasthenia gravis, muscular dystrophy)
• cardiac disease (eg. prolong QTc syndrome) and / or cardiac ischemia
• renal failure
• liver failure
• allergic reaction to the drugs used in the study
• treatment with oral contraceptives, toremifene, flucloxacillin and fusidic acid
• known or suspected pregnancy
• anticoagulants treatment
• hereditary deficiencies of vitamin K dependent coagulation factors
• patients with pre-existing coagulopathy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Comparison of the recovery time from neuromuscular blockade after<br>administration of sugammadex dosed on the basis of total body weight<br>or corrected body weight in morbidly obese patients;Secondary Objective: Comparison of complete recovery of TOF ratio ?1 between morbidly<br>obese patients receiving sugammadex dosed on the basis of total body<br>weight or corrected body weight.;Primary end point(s): Difference in the time required for complete recovery (TOF ratio =1) from moderate or profound neuromuscular block after administration of sugammadex (TBW group vs. group CBW) during recovery from general anesthesia at the end of the surgical procedure.;Timepoint(s) of evaluation of this end point: At the end of the surgical procedure
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Difference in the time required to obtain a normalized TOF ratio (TOF ratio post-reversal / TOF ratio baseline) =1 after administration of sugammadex (TBW group vs. group CBW). Adverse effects;Timepoint(s) of evaluation of this end point: Until hospital discharge