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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

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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Drug: Fentanyl Drug: Ketamine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fentanyl Versus Ketamine Supplementation for Prpofol Anesthesia During Balloon Insertion in Morbidly Obese Patients
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : March 20, 2019
Estimated Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Fentanyl group Drug: Fentanyl
0.5 mic/kg fentanyl will be given immediately before the procedure

Experimental: Ketamine group Drug: Ketamine
0.25 mg ketamine will be administered immediately before the procedure

Primary Outcome Measures :
  1. Propofol consumption (milligrams) [ Time Frame: 24 hours after the endoscopy ]
    Dose of prpofol (mg/kg) required for sedation during gastric balloon insertion

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • morbid obese indicated for gastric balloon insertion

Exclusion Criteria:

- Refusal Hypersensitivity to any of the study drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03747094

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Mansoura university
Al Manşūrah, Dkahleya, Egypt
Sponsors and Collaborators
Mansoura University
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Responsible Party: AlRefaey Kandeel, lecturer of anesthesia, Mansoura University Identifier: NCT03747094    
Other Study ID Numbers: Sedation for balloon insertion
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity, Morbid
Nutrition Disorders
Body Weight
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Adjuvants, Anesthesia