Comparison of sugammadex dosed according to total (TBW) and corrected body weight (CBW) for reversal of rocuronium-induced neuromuscular blockade in morbidly obese patients undergoing laparoscopic bariatric surgery. A double-blind, randomized controlled trial.

Total versus corrected body weight for dosage of sugammadex in morbidly obese patients.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005052-25-IT

Enrollment

204

Registered

2015-05-18

Start date

2015-06-29

Completion date

Unknown

Last updated

2018-02-26

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 MedDRA version: 18.0 Level: PT Classification code 10057286 Term: Neuromuscular blockade reversal System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Bridion Pharmaceutical Form: Concentrate for solution for injection

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 (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

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 • anticoagulants treatment • hereditary deficiencies of vitamin K dependent coagulation factors • patients with pre-existing coagulopathy

Design outcomes

Primary

Measure	Time frame
Main Objective: Comparison of the recovery time from neuromuscular blockade after administration of sugammadex dosed on the basis of total body weight or corrected body weight in morbidly obese patients;Secondary Objective: Comparison of complete recovery of TOF ratio ?1 between morbidly obese patients receiving sugammadex dosed on the basis of total body 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	—

Measure

Time frame

Main Objective: Comparison of the recovery time from neuromuscular blockade after administration of sugammadex dosed on the basis of total body weight or corrected body weight in morbidly obese patients;Secondary Objective: Comparison of complete recovery of TOF ratio ?1 between morbidly obese patients receiving sugammadex dosed on the basis of total body 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

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactNucleo per la Ricerca Clinica

Azienda Ospedaliera di Padova

ucleoricercaclinica@sanita.padova.it0498214439

Outcome results

None listed

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