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.

Postoperative pulmonary function in patients undergoing laparoscopic sleeve gastrectomy after administration of sugammadex and neostigmine. A double-blind, randomized controlled trial. - NEVERSU

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005116-41-IT

Enrollment

Registered

2015-04-13

Start date

2015-06-24

Completion date

Unknown

Last updated

2018-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reversal of rocuronium-induced neuromuscular blockade

Interventions

Trade Name: Bridion 100 mg/ml solution for injection Product Name: Sugammadex Product Code: V03AB35 Pharmaceutical Form: Solution for injection Trade Name: PROSTIGMINA Product Name: Neostigmine Pharm

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Comparison of the recovery time from neuromuscular blockade after administration of sugammadex e neostigmine in morbidly obese patients;Secondary Objective: Postoperative pulmonary function evaluation after sugammadex and neostigmine administration for recovery of neuromuscular blockade in patients undergoing laparoscopic sleeve gastrectomy.;Primary end point(s): Timing of the reversal Difference in the time required for complete recovery (TOF ratio =0.9) 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	—

Measure

Time frame

Main Objective: Comparison of the recovery time from neuromuscular blockade after administration of sugammadex e neostigmine in morbidly obese patients;Secondary Objective: Postoperative pulmonary function evaluation after sugammadex and neostigmine administration for recovery of neuromuscular blockade in patients undergoing laparoscopic sleeve gastrectomy.;Primary end point(s): Timing of the reversal Difference in the time required for complete recovery (TOF ratio =0.9) 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

Measure	Time frame
Secondary end point(s): Spirometric evaluation of respiratory function upon awakening from general anesthesia after reversal of neuromuscular blockade with sugammadex and neostigmine;Timepoint(s) of evaluation of this end point: For two hours after awakening from general anesthesia	—

Countries

Italy

Contacts

Public ContactMichele Carron

University of Padova

michele.carron@unipd.it+390498213090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026