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

Primary Purpose

Muscle Relaxation

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sugammadex
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Muscle Relaxation focused on measuring Sugammadex, morbidly obese patients, bariatric surgery, neuromuscular blockade

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine, Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

Sugammadex given in a dose of 2mg/kg based on ideal body weight

Sugammadex given in a dose of 2mg/kg based on adjusted body weight

Sugammadex given in a dose of 2mg/kg based on actual body weight

Outcomes

Primary Outcome Measures

Reversal Time
Reversal Time: time from administration of Sugammadex to train of four (TOF) ratio ≥ 0.9 will be used as primary outcome.

Secondary Outcome Measures

duration of stay in PACU
period of stay in the PACU
Time need for Extubation
time from administration of sugammadex to extubation

Full Information

First Posted
December 17, 2017
Last Updated
December 20, 2017
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03381209
Brief Title
The Effect of Sugammadex Given Based on Ideal, Actual or Adjusted Body Weight on Reversal of Rocuronium.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
June 10, 2017 (Actual)
Primary Completion Date
November 10, 2017 (Actual)
Study Completion Date
November 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Relaxation
Keywords
Sugammadex, morbidly obese patients, bariatric surgery, neuromuscular blockade

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Sugammadex given in a dose of 2mg/kg based on ideal body weight
Arm Title
Group B
Arm Type
Experimental
Arm Description
Sugammadex given in a dose of 2mg/kg based on adjusted body weight
Arm Title
Group C
Arm Type
Experimental
Arm Description
Sugammadex given in a dose of 2mg/kg based on actual body weight
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Other Intervention Name(s)
bridion
Intervention Description
sugammadex given based on 3 measurements of body weights
Primary Outcome Measure Information:
Title
Reversal Time
Description
Reversal Time: time from administration of Sugammadex to train of four (TOF) ratio ≥ 0.9 will be used as primary outcome.
Time Frame
5 minutes after sugammadex administration
Secondary Outcome Measure Information:
Title
duration of stay in PACU
Description
period of stay in the PACU
Time Frame
60 minutes after admission to the PACU
Title
Time need for Extubation
Description
time from administration of sugammadex to extubation
Time Frame
10 minutes after sugammadex administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walid Nofal, MD
Organizational Affiliation
Anesthesiology department, Faculty of Medicine, Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Ain Shams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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