Comparison of Three Different Doses Sugammadex Based on Ideal Body Weight for Reversal of Moderate Rocuronium-induced Neuromuscular Blockade in Laparoscopic Bariatric Surgery.
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Assiut University
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- sugammadex time following a dose of 1.5 mg / kg of sugammadex according to IBW in comparison to 2, and 4 mg / kg,
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
group 1
patients were given 1.5 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)
Intervention: sugammadex reversal of neuromuscular blockade (Drug)
group II
patients were given 2 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)
Intervention: sugammadex reversal of neuromuscular blockade (Drug)
group III
patients were given 4 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)
Intervention: sugammadex reversal of neuromuscular blockade (Drug)
Outcomes
Primary Outcomes
sugammadex time following a dose of 1.5 mg / kg of sugammadex according to IBW in comparison to 2, and 4 mg / kg,
Time Frame: 2 hrs
Secondary Outcomes
- extubation time(2 hrs)
Investigators
Fatma Adel El sherif
principal investigator
Assiut University