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Sedation for Upper Gastrointestinal Endoscopy in Pediatric Patients

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: NCT02863861
Recruitment Status : Completed
First Posted : August 11, 2016
Last Update Posted : December 22, 2016
Sponsor:
Information provided by (Responsible Party):
Akram Mohamed Mohamed Amer, Ain Shams University

Brief Summary:
The purpose of this study is to compere between Propofol-Ketamine combination and Dexmedetomidine-Ketamine combination for sedation in upper gastrointestinal endoscopy in paediatric patients.

Condition or disease Intervention/treatment Phase
Upper Gastrointestinal Endoscopy Drug: Dexmedetomidine-ketamine Drug: propofol-ketamine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Official Title: Comparative Study Between Propofol-Ketamine Combination and Dexmedetomidine-Ketamine Combination for Sedation in Upper Gastrointestinal Endoscopy in Paediatric Patients.
Study Start Date : September 2016
Actual Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Group PK
Propofol-Ketamine group: patients in this group will receive IV ketamine at a dose of 1mg.kg-1 in addition to IV propofol 1mg.kg-1 for induction with added doses of propofol 1mg.kg-1 when needed.
Drug: propofol-ketamine
Experimental: Group DK
Dexmedetomidine-Ketamine group: patients in this group will receive IV ketamine at a dose of 1mg.kg-1 in addition to IV dexmedetomidine 0.5 mcg.kg-1 for induction with additional doses of dexmedetomidine 0.5mcg.kg-1 when required
Drug: Dexmedetomidine-ketamine



Primary Outcome Measures :
  1. length of stay in PACU [ Time Frame: three months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists ASA I-II patients aging 2-7 years.

Exclusion Criteria:

known allergy to any of the study drugs, significant cardiovascular disease vomiting.


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): NCT02863861


Locations
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Egypt
Ain shams university- faculty of medicine- department of anesthesia, intensive care and pain management
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Akram Mohamed Mohamed Amer, Lecturer in Department of Anesthesiology, Intensive Care, and Pain Management, Faculty of Medicine, Ain-Shams University, Ain Shams University
ClinicalTrials.gov Identifier: NCT02863861    
Other Study ID Numbers: FMASU R 12/2016
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Keywords provided by Akram Mohamed Mohamed Amer, Ain Shams University:
Sedation
Pediatric Patients
Additional relevant MeSH terms:
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Dexmedetomidine
Ketamine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents