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Ketamine Compared to Propofol for Pediatric GI Endoscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00614159
First Posted: February 13, 2008
Last Update Posted: July 2, 2009
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.
Information provided by:
State University of New York - Upstate Medical University
  Purpose
Elective outpatient endoscopy for children can be safely performed under general anesthesia with either propofol (1) or ketamine (2) infusions. Both infusions have an advantage over general anesthesia with volatile agents because they do not require intubation. The goal of both infusions is to have the patient breath spontaneously without reacting to the endoscopy which is a noxious stimulus. Patient movement, stridor and vomiting are can interrupt the procedure and increase overall OR time. Propofol also carries the added risk of causing apnea. This side effect is not commonly seen with Ketamine. Our hypothesis is that Ketamine's profile makes it a superior drug to Propofol for elective outpatient endoscopy because of reduced profound intra-operative interruptions and faster recovery time. We plan a study of pediatric patients ages 1 to 10 years old undergoing elective outpatient endoscopy. The patients will be randomized to receiving either a Ketamine or Propofol infusion, and the intra-operative interruptions will be documented by the anesthesiologist. The Post Anesthetic Care Unit (PACU) time to recovery will be monitored and recorded by a third party.

Condition Intervention
Endoscopy Drug: Ketamine Drug: Propofol

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Estimated Enrollment: 34
Study Start Date: October 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
GI Endoscopy Drug: Ketamine
Weight based dosage for Peds subjects, used for duration of the endoscopy.
Drug: Propofol
Weight based dosage for Peds subjects, used for duration of the endoscopy.

  Eligibility

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pre-op setting, previously scheduled for GI Endoscopy
Criteria

Inclusion Criteria:

  • Age 1-10
  • Endoscopy with sedation scheduled

Exclusion Criteria:

  • A history of chronic respiratory disease
  • Upper respiratory infection
  • Developmental delays
  • Dysrhythmias
  • Increased intercranial pressure
  • Any sedatives or narcotics up to 6 weeks prior to procedure.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Xiuli Zhang, MD, Upstate Medical University
ClinicalTrials.gov Identifier: NCT00614159     History of Changes
Other Study ID Numbers: 5545UMU
First Submitted: January 31, 2008
First Posted: February 13, 2008
Last Update Posted: July 2, 2009
Last Verified: June 2009

Keywords provided by State University of New York - Upstate Medical University:
Child age 1-10 years having a GI Endoscopy with sedation

Additional relevant MeSH terms:
Propofol
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action