Sedation of Morbidly Obese for Balloon Insertion (SedBaloon)

• ClinicalTrials.gov Identifier: NCT03747094
• Recruitment Status: Unknown
• First Posted: November 20, 2018
• Last Update Posted: November 20, 2018
• Sponsor: Mansoura University
• Information provided by (Responsible Party): AlRefaey Kandeel, Mansoura University

Tracking Information

• First Submitted Date: November 13, 2018
• First Posted Date: November 20, 2018
• Last Update Posted Date: November 20, 2018
• Estimated Study Start Date: December 1, 2018
• Estimated Primary Completion Date: March 20, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sedation of Morbidly Obese for Balloon Insertion
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Morbid Obesity

Intervention

• 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

• Active Comparator: Fentanyl group
  Intervention: Drug: Fentanyl
• Experimental: Ketamine group
  Intervention: Drug: Ketamine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 17, 2018): 70
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 15, 2019
• Estimated Primary Completion Date: March 20, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• morbid obese indicated for gastric balloon insertion

Exclusion Criteria:

- Refusal Hypersensitivity to any of the study drugs

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT03747094
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Responsible Party: AlRefaey Kandeel, Mansoura University
• Study Sponsor: Mansoura University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Mansoura University
• Verification Date: November 2018