Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy Gastrointestinal Endoscopy
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ClinicalTrials.gov Identifier: NCT03235609 |
Recruitment Status : Unknown
Verified August 2017 by Mohamed galal aly, Assiut University.
Recruitment status was: Not yet recruiting
First Posted : August 1, 2017
Last Update Posted : August 3, 2017
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Sponsor:
Assiut University
Information provided by (Responsible Party):
Mohamed galal aly, Assiut University
Tracking Information | |||||
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First Submitted Date ICMJE | July 27, 2017 | ||||
First Posted Date ICMJE | August 1, 2017 | ||||
Last Update Posted Date | August 3, 2017 | ||||
Estimated Study Start Date ICMJE | August 16, 2017 | ||||
Estimated Primary Completion Date | June 15, 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
incidence of desaturation [ Time Frame: up to 2 days after operation ] when oxygen saturation below 90%
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
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 During Pediatric Diagnostic Gastrointestinal Endoscopy Gastrointestinal Endoscopy | ||||
Official Title ICMJE | Propofol-Ketamine vs. Propofol-Fentanyl for Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy | ||||
Brief Summary | comparison between propofol-fentanyl and propofol-ketamine for sedation in pediatric diagnostic gastrointestinal endoscopy. | ||||
Detailed Description | It is a prospective double blinded controlled study that will be carried out on 60 pediatric patients undergoing GIT endoscopy; they will be divided into two groups of 30 patients each:- Group I (PF): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV. Group II (KF): will receive Ketofol (1 ketamine: 4 propofol) 0.5 mg/kg ketamine + 2 mg/kg propofol IV. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Masking Description: double blind Primary Purpose: Treatment
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Condition ICMJE | Sedation | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Michaud L; Francophone Pediatric Hepatology, Gastroenterology, and Nutrition Group. Sedation for diagnostic upper gastrointestinal endoscopy: a survey of the Francophone Pediatric Hepatology, Gastroenterology, and Nutrition Group. Endoscopy. 2005 Feb;37(2):167-70. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | August 15, 2018 | ||||
Estimated Primary Completion Date | June 15, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 6 Years to 16 Years (Child) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03235609 | ||||
Other Study ID Numbers ICMJE | 17100212 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Mohamed galal aly, Assiut University | ||||
Study Sponsor ICMJE | Assiut University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Assiut University | ||||
Verification Date | August 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |