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

March 18, 2016 updated by: Fatma Adel El sherif, Assiut University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assuit, Egypt, 171516
        • South Egypt Cancer Instuite

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 hrs

Secondary Outcome Measures

Outcome Measure
Time Frame
extubation time
Time Frame: 2 hrs
2 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Ahmed H Othman, MD, ASSUIT UNVERSITY

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (ESTIMATE)

March 18, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

March 21, 2016

Last Update Submitted That Met QC Criteria

March 18, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 250

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bariatric Patients

Clinical Trials on sugammadex reversal of neuromuscular blockade

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe