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NCT03747094 Clinical Trial

Sedation of Morbidly Obese for Balloon Insertion

Morbid Obesity Clinical Trial

— SedBaloon  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03747094
Other study ID # Sedation for balloon insertion
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date April 15, 2019

Study information
Verified date November 2018
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 70
Est. completion date April 15, 2019
Est. primary completion date March 20, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria:

- morbid obese indicated for gastric balloon insertion

Exclusion Criteria:

- Refusal Hypersensitivity to any of the study drugs

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fentanyl
0.5 mic/kg fentanyl will be given immediately before the procedure
• Ketamine
0.25 mg ketamine will be administered immediately before the procedure

Locations
Country Name City State
Egypt Mansoura university Al Mansurah Dkahleya

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Propofol consumption (milligrams) Dose of prpofol (mg/kg) required for sedation during gastric balloon insertion 24 hours after the endoscopy
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