The Effect of Sugammadex Given Based on Ideal, Actual or Adjusted Body Weight on Reversal of Rocuronium.

December 20, 2017 updated by: Walid Nofal, Ain Shams University

The Effect of Sugammadex Given Based on Ideal, Actual or Adjusted Body Weights on Reversal of Neuromuscular Blockade in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery

The aim of this study is compare the reversal of rocuronium induced neuromuscular blockade in morbidly obese patients using three doses of sugammadex; based on ideal body weight, adjusted body weight, and actual body weight.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is compare the reversal of rocuronium induced neuromuscular blockade in morbidly obese patients using three doses of sugammadex; based on ideal body weight, adjusted body weight, and actual body weight. Reversal Time: time from administration of Sugammadex to train of four (TOF) ratio ≥ 0.9 will be used as primary outcome.

Time need for extubation (time from administration of sugammadex to extubation), and duration of stay in post anesthesia care unit (PACU), will be used as secondary outcome.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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
      • Cairo, Egypt
        • Faculty of Medicine, Ain Shams University

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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients older than 18 years and under 45 years,
  • body mass index ≥ 40 kg/m2, with indication of bariatric surgery

Exclusion Criteria:

  • Patients with comorbid including: neuromuscular disease, renal impairment, and patients with difficult airway were excluded from this study.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Sugammadex given in a dose of 2mg/kg based on ideal body weight
Drug: Sugammadex
sugammadex given based on 3 measurements of body weights
Other Names:
  • bridion
Experimental: Group B
Sugammadex given in a dose of 2mg/kg based on adjusted body weight
Drug: Sugammadex
sugammadex given based on 3 measurements of body weights
Other Names:
  • bridion
Experimental: Group C
Sugammadex given in a dose of 2mg/kg based on actual body weight
Drug: Sugammadex
sugammadex given based on 3 measurements of body weights
Other Names:
  • bridion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reversal Time
Time Frame: 5 minutes after sugammadex administration
Reversal Time: time from administration of Sugammadex to train of four (TOF) ratio ≥ 0.9 will be used as primary outcome.
5 minutes after sugammadex administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of stay in PACU
Time Frame: 60 minutes after admission to the PACU
period of stay in the PACU
60 minutes after admission to the PACU
Time need for Extubation
Time Frame: 10 minutes after sugammadex administration
time from administration of sugammadex to extubation
10 minutes after sugammadex administration

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Walid Nofal, MD, Anesthesiology department, Faculty of Medicine, Ain Shams University

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 (Actual)

June 10, 2017

Primary Completion (Actual)

November 10, 2017

Study Completion (Actual)

November 10, 2017

Study Registration Dates

First Submitted

December 17, 2017

First Submitted That Met QC Criteria

December 20, 2017

First Posted (Actual)

December 21, 2017

Study Record Updates

Last Update Posted (Actual)

December 21, 2017

Last Update Submitted That Met QC Criteria

December 20, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R 39/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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