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

Assiut University

Status and phase: Completed; Phase 3

Conditions: Bariatric Patients

Treatments: Drug: sugammadex reversal of neuromuscular blockade

Study type: Interventional

Funder types: Other

Identifiers

NCT02713113

250

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups

group 1

Active Comparator group

Description:

patients were given 1.5 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)

Treatment:

Drug: sugammadex reversal of neuromuscular blockade

group II

Active Comparator group

Description:

patients were given 2 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)

Treatment:

Drug: sugammadex reversal of neuromuscular blockade

group III

Active Comparator group

Description:

patients were given 4 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)

Treatment:

Drug: sugammadex reversal of neuromuscular blockade