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Sedation of Morbidly Obese for Balloon Insertion (SedBaloon)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03747094
Recruitment Status : Unknown
Verified November 2018 by AlRefaey Kandeel, Mansoura University.
Recruitment status was:  Not yet recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Information provided by (Responsible Party):
AlRefaey Kandeel, Mansoura University

Tracking Information
First Submitted Date  ICMJE November 13, 2018
First Posted Date  ICMJE November 20, 2018
Last Update Posted Date November 20, 2018
Estimated Study Start Date  ICMJE December 1, 2018
Estimated Primary Completion Date March 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2018)
Propofol consumption (milligrams) [ Time Frame: 24 hours after the endoscopy ]
Dose of prpofol (mg/kg) required for sedation during gastric balloon insertion
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Sedation of Morbidly Obese for Balloon Insertion
Official Title  ICMJE Fentanyl Versus Ketamine Supplementation for Prpofol Anesthesia During Balloon Insertion in Morbidly Obese Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Morbid Obesity
Intervention  ICMJE
  • Drug: Fentanyl
    0.5 mic/kg fentanyl will be given immediately before the procedure
  • Drug: Ketamine
    0.25 mg ketamine will be administered immediately before the procedure
Study Arms  ICMJE
  • Active Comparator: Fentanyl group
    Intervention: Drug: Fentanyl
  • Experimental: Ketamine group
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 17, 2018)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 15, 2019
Estimated Primary Completion Date March 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • morbid obese indicated for gastric balloon insertion

Exclusion Criteria:

- Refusal Hypersensitivity to any of the study drugs

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03747094
Other Study ID Numbers  ICMJE Sedation for balloon insertion
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party AlRefaey Kandeel, Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mansoura University
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP