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Sedation of Morbidly Obese for Balloon Insertion (SedBaloon)

Primary Purpose

Morbid Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fentanyl
Ketamine
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity

Eligibility Criteria

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

Inclusion Criteria:

  • morbid obese indicated for gastric balloon insertion

Exclusion Criteria:

- Refusal Hypersensitivity to any of the study drugs

Sites / Locations

  • Mansoura university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fentanyl group

Ketamine group

Arm Description

Outcomes

Primary Outcome Measures

Propofol consumption (milligrams)
Dose of prpofol (mg/kg) required for sedation during gastric balloon insertion

Secondary Outcome Measures

Full Information

First Posted
November 13, 2018
Last Updated
November 17, 2018
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03747094
Brief Title
Sedation of Morbidly Obese for Balloon Insertion
Acronym
SedBaloon
Official Title
Fentanyl Versus Ketamine Supplementation for Prpofol Anesthesia During Balloon Insertion in Morbidly Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
March 20, 2019 (Anticipated)
Study Completion Date
April 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fentanyl group
Arm Type
Active Comparator
Arm Title
Ketamine group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
0.5 mic/kg fentanyl will be given immediately before the procedure
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
0.25 mg ketamine will be administered immediately before the procedure
Primary Outcome Measure Information:
Title
Propofol consumption (milligrams)
Description
Dose of prpofol (mg/kg) required for sedation during gastric balloon insertion
Time Frame
24 hours after the endoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: morbid obese indicated for gastric balloon insertion Exclusion Criteria: - Refusal Hypersensitivity to any of the study drugs
Facility Information:
Facility Name
Mansoura university
City
Al Manşūrah
State/Province
Dkahleya
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Sedation of Morbidly Obese for Balloon Insertion

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