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Ketamine Compared to Propofol for Pediatric GI 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: NCT00614159
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : July 2, 2009
Sponsor:
Information provided by:
State University of New York - Upstate Medical University

Tracking Information
First Submitted Date January 31, 2008
First Posted Date February 13, 2008
Last Update Posted Date July 2, 2009
Study Start Date October 2007
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ketamine Compared to Propofol for Pediatric GI Endoscopy
Official Title Not Provided
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Pre-op setting, previously scheduled for GI Endoscopy
Condition Endoscopy
Intervention
  • 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.
Study Groups/Cohorts GI Endoscopy
Interventions:
  • Drug: Ketamine
  • Drug: Propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: February¬†12,¬†2008)
34
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 10 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT00614159
Other Study ID Numbers 5545UMU
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Xiuli Zhang, MD, Upstate Medical University
Study Sponsor State University of New York - Upstate Medical University
Collaborators Not Provided
Investigators Not Provided
PRS Account State University of New York - Upstate Medical University
Verification Date June 2009