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Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy Gastrointestinal Endoscopy

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.
 
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
Sponsor:
Information provided by (Responsible Party):
Mohamed galal aly, Assiut University

Tracking Information
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
 (submitted: July 31, 2017)
incidence of desaturation [ Time Frame: up to 2 days after operation ]
when oxygen saturation below 90%
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
Condition  ICMJE Sedation
Intervention  ICMJE
  • Drug: Fentanyl
    fentanyl used with propofol for sedation
    Other Name: Fentanyl Citrate
  • Drug: Ketamine
    ketamine used with propofol for sedation
    Other Name: katalar
Study Arms  ICMJE
  • Active Comparator: Fentanyl
    Group I (FP): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV.
    Intervention: Drug: Fentanyl
  • Active Comparator: Ketamine
    Group II (KP): will receive 0.5 mg/kg ketamine + 2 mg/kg propofol IV.
    Intervention: Drug: Ketamine
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.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 31, 2017)
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:

  • Pediatric patients undergoing diagnostic GIT endoscopy
  • ASA I-II

Exclusion Criteria:

  • Emergency endoscopy
  • Respiratory infection and hyperactive airways
  • History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs
  • Morbid obesity, and neuropsychiatric disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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