Efficacy of Low Dose Sugammadex in Reversal of NMB in Laparoscopic Barbaric Surgery

Phase 3

Completed

• Conditions: Bariatric Patients
• Interventions: Drug: sugammadex reversal of neuromuscular blockade

• Registration Number: NCT02713113
• Lead Sponsor: Assiut University

Brief Summary

the investigators aimed to compare the efficacy and safety of sugammadex at doses of 1.5, 2, and 4 mg/ kg for the reversal of moderate rocuronium-induced neuromuscular blockade in laparoscopic bariatric surgery.

Detailed Description

Patients were randomly assigned using a randomization-computer program into three groups according to the dose of sugammadex administrated (according to the IBW after T2 of TOF):

Group I: patients were given 1.5 mg / kg. Group II: patients were given 2 mg / kg. Group III: patients were given 4 mg / kg.

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2016-02
• Status Verified: 2016-03
• Study Completion: 2016-03
• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-18
• Last Update Submitted: 2016-03-18
• Last Update Posted: 2016-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• morbidly obese patients of both sex (BMI > 40 kg.m-2)
• scheduled for elective laparoscopic bariatric surgery (gastric bypass or sleeve surgery) under general anesthesia using rocuronium for tracheal intubation and maintenance of NMB
• aged between 18 and 60 years and classified as ASA II - III

Exclusion Criteria

• liver and renal dysfunction,
• disabling neuropsychiatric disorders,
• history of stroke, brain trauma in the last 12 months
• hypersensitivity to anesthetics, history of myocardial infarction, congestive heart failure
• difficult tracheal intubation, and known or suspected disorder affecting NMB.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	sugammadex reversal of neuromuscular blockade	patients were given 1.5 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)
group III	sugammadex reversal of neuromuscular blockade	patients were given 4 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)
group II	sugammadex reversal of neuromuscular blockade	patients were given 2 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)

Primary Outcome Measures

Name	Time	Method
sugammadex time following a dose of 1.5 mg / kg of sugammadex according to IBW in comparison to 2, and 4 mg / kg,	2 hrs

Secondary Outcome Measures

Name	Time	Method
extubation time	2 hrs

Trial Locations

Locations (1)

South Egypt Cancer Instuite; 🇪🇬 Assuit, Egypt