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Ketamine Compared to Propofol for Pediatric GI Endoscopy
This study is currently recruiting participants.
Verified by State University of New York - Upstate Medical University, December 2008
Sponsored by: State University of New York - Upstate Medical University
Information provided by: State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00614159
  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

MedlinePlus related topics: Anesthesia Endoscopy
Drug Information available for: Propofol Ketamine Ketamine hydrochloride
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective

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

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 34
Study Start Date: October 2007
Estimated Study Completion Date: June 2009
Estimated 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

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614159

Contacts
Contact: Kimberly A Kasprowicz, MS,RN,FNP 315-464-4892 kasprowk@upstate.edu

Locations
United States, New York
Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Kimberly A Kasprowicz, MS, RN, FNP     315-464-4892     kasprowk@upstate.edu    
Sponsors and Collaborators
State University of New York - Upstate Medical University
  More Information

Responsible Party: Upstate Medical University ( Xiuli Zhang, MD )
Study ID Numbers: 5545UMU
Study First Received: January 31, 2008
Last Updated: December 1, 2008
ClinicalTrials.gov Identifier: NCT00614159  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Excitatory Amino Acids
Ketamine
Propofol

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

ClinicalTrials.gov processed this record on January 14, 2009