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

NCT ID: NCT03381209

Last Updated: 2017-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-10

Study Completion Date

2017-11-10

Brief Summary

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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

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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.

Conditions

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Muscle Relaxation

Keywords

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Sugammadex morbidly obese patients bariatric surgery neuromuscular blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

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

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

sugammadex given based on 3 measurements of body weights

Group B

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

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

sugammadex given based on 3 measurements of body weights

Group C

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

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

sugammadex given based on 3 measurements of body weights

Interventions

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Sugammadex

sugammadex given based on 3 measurements of body weights

Intervention Type DRUG

Other Intervention Names

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bridion

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Walid Nofal

Lecturer of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Walid Nofal, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology department, Faculty of Medicine, Ain Shams University

Locations

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Faculty of Medicine, Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU R 39/2017

Identifier Type: -

Identifier Source: org_study_id