Sedation of Morbidly Obese for Balloon Insertion

NCT ID: NCT03747094

Last Updated: 2018-11-20

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-04-15

Brief Summary

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This prospective study will assess the value of different supplements to orpofol bases anesthesia in morbidly obes e patients scheduled for balloon insertion. Two common drugs will be added to propofol bases anesthesia;Ketamine or fentanyl. Effect on prpofol consumption, post-procedure recovery profile, and patient satisfaction will be the study objectives.

Detailed Description

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Conditions

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Fentanyl group

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

0.5 mic/kg fentanyl will be given immediately before the procedure

Ketamine group

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

0.25 mg ketamine will be administered immediately before the procedure

Interventions

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Fentanyl

0.5 mic/kg fentanyl will be given immediately before the procedure

Intervention Type DRUG

Ketamine

0.25 mg ketamine will be administered immediately before the procedure

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* morbid obese indicated for gastric balloon insertion

Exclusion Criteria

\- Refusal Hypersensitivity to any of the study drugs
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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AlRefaey Kandeel

lecturer of anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mansoura university

Al Manşūrah, Dkahleya, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Sedation for balloon insertion

Identifier Type: -

Identifier Source: org_study_id

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