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

NCT ID: NCT02713113

Last Updated: 2016-03-21

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

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bariatric Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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group 1

patients were given 1.5 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)

Group Type ACTIVE_COMPARATOR

sugammadex reversal of neuromuscular blockade

Intervention Type DRUG

group II

patients were given 2 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)

Group Type ACTIVE_COMPARATOR

sugammadex reversal of neuromuscular blockade

Intervention Type DRUG

group III

patients were given 4 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)

Group Type ACTIVE_COMPARATOR

sugammadex reversal of neuromuscular blockade

Intervention Type DRUG

Interventions

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sugammadex reversal of neuromuscular blockade

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Adel El sherif

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed H Othman, MD

Role: STUDY_DIRECTOR

ASSUIT UNVERSITY

Locations

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South Egypt Cancer Instuite

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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250

Identifier Type: -

Identifier Source: org_study_id

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