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Completed

NCT Number: NCT02713113

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

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.

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Key information

Conditions

Bariatric Patients

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

South Egypt Cancer Instuite

Asyut, 171516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sugammadex reversal of neuromuscular blockade

Drug

Primary outcomes

  1. 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

  1. extubation time

    Time frame: 2 hrs

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 18, 2016
Registry last updated
Mar 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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