Ketamine Compared to Propofol for Pediatric GI Endoscopy - Tabular View

Tracking Information
First Received Date ^ICMJE	January 31, 2008
Last Updated Date	June 30, 2009
Start Date ^ICMJE	October 2007
Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00614159 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Ketamine Compared to Propofol for Pediatric GI Endoscopy
Official Title ^ICMJE
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
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Cohort, Prospective
Condition ^ICMJE	Endoscopy
Intervention ^ICMJE	Drug: Ketamine Drug: Propofol
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	34
Completion Date	June 2009
Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	1 Year to 10 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00614159
Responsible Party	Xiuli Zhang, MD, Upstate Medical University
Study ID Numbers ^ICMJE	5545UMU
Study Sponsor ^ICMJE	State University of New York - Upstate Medical University
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	State University of New York - Upstate Medical University
Verification Date	June 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP