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

Comparison of Three Different Doses Sugammadex Based on Ideal Body Weight for Reversal of Moderate Rocuronium-induced Neuromuscular Blockade in Laparoscopic Bariatric Surgery.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02713113
Enrollment
180
Registered
2016-03-18
Start date
2015-03-31
Completion date
2016-03-31
Last updated
2016-03-21

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

Conditions

Bariatric Patients

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.

Interventions

DRUGsugammadex reversal of neuromuscular blockade

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
extubation time2 hrs

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026