Sedation of Morbidly Obese for Balloon Insertion (SedBaloon)

November 17, 2018 updated by: AlRefaey Kandeel, Mansoura University

Fentanyl Versus Ketamine Supplementation for Prpofol Anesthesia During Balloon Insertion in Morbidly Obese Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dkahleya
      • Al Manşūrah, Dkahleya, Egypt
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • morbid obese indicated for gastric balloon insertion

Exclusion Criteria:

- Refusal Hypersensitivity to any of the study drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ketamine group
Drug: Ketamine
0.25 mg ketamine will be administered immediately before the procedure
ACTIVE_COMPARATOR: Fentanyl group
Drug: Fentanyl
0.5 mic/kg fentanyl will be given immediately before the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Propofol consumption (milligrams)
Time Frame: 24 hours after the endoscopy
Dose of prpofol (mg/kg) required for sedation during gastric balloon insertion
24 hours after the endoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2018

Primary Completion (ANTICIPATED)

March 20, 2019

Study Completion (ANTICIPATED)

April 15, 2019

Study Registration Dates

First Submitted

November 13, 2018

First Submitted That Met QC Criteria

November 17, 2018

First Posted (ACTUAL)

November 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 17, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sedation for balloon insertion

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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