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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

Study Description
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Brief Summary:
comparison between propofol-fentanyl and propofol-ketamine for sedation in pediatric diagnostic gastrointestinal endoscopy.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: double blind
Primary Purpose: Treatment
Official Title: Propofol-Ketamine vs. Propofol-Fentanyl for Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy
Estimated Study Start Date : August 16, 2017
Estimated Primary Completion Date : June 15, 2018
Estimated Study Completion Date : August 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Fentanyl
Group I (FP): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV.
 Drug: Fentanyl
fentanyl used with propofol for sedation
Other Name: Fentanyl Citrate
Active Comparator: Ketamine
Group II (KP): will receive 0.5 mg/kg ketamine + 2 mg/kg propofol IV.
 Drug: Ketamine
ketamine used with propofol for sedation
Other Name: katalar


Outcome Measures
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Primary Outcome Measures :
  1. incidence of desaturation [ Time Frame: up to 2 days after operation ]
    when oxygen saturation below 90%


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03235609


Contacts
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Contact: Mohamed Aly 00201062011126 galalm1967@yahoo.com

Sponsors and Collaborators
Assiut University
More Information
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Publications:

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Responsible Party: Mohamed galal aly, Assistant Professor, Assiut University
ClinicalTrials.gov Identifier: NCT03235609    
Other Study ID Numbers: 17100212
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017

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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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Fentanyl
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
 Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia