Comparison between sugammadex and neostigmine in the recovery of rocuronium-induced neuromuscular blockade and impact on postoperative pulmonary function in patients undergoing laparoscopic sleeve gastrectomy. A double-blind, randomized controlled trial.

Phase 1

• Conditions: Reversal of rocuronium-induced neuromuscular blockade; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-005116-41-IT
• Lead Sponsor: niversity of Padova

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-13
• Last Update Posted: 12 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• age over 18 years;
• morbid obesity class II (with comorbidities), and class III;
• patients undergoing surgery for laparoscopic bariatric surgery
• presence of neuromuscular monitoring
• presence of moderate neuromuscular blockade (T1-T2 to 10% TOF
ratio) at the time of reversal
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 72
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• 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;
•spontaneous recovery at the end of surgery and / or the presence of
profound NMB (no twitches to TOF) at the time of reversal

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 e neostigmine in morbidly obese patients;Secondary Objective: Postoperative pulmonary function evaluation after sugammadex and<br>neostigmine administration for recovery of neuromuscular blockade in<br>patients undergoing laparoscopic sleeve gastrectomy.;Primary end point(s): Timing of the reversal<br>Difference in the time required for complete recovery (TOF ratio =0.9)<br>from moderate or profound neuromuscular block after administration of<br>sugammadex (TBW group vs. group CBW) during recovery from general<br>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): Spirometric evaluation of respiratory function upon awakening from<br>general anesthesia after reversal of neuromuscular blockade with<br>sugammadex and neostigmine;Timepoint(s) of evaluation of this end point: For two hours after awakening from general anesthesia