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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00614159
Other study ID # 5545UMU
Secondary ID
Status Completed
Phase N/A
First received January 31, 2008
Last updated June 30, 2009
Start date October 2007
Est. completion date June 2009

Study information

Verified date June 2009
Source State University of New York - Upstate Medical University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 10 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Ketamine
Weight based dosage for Peds subjects, used for duration of the endoscopy.
Propofol
Weight based dosage for Peds subjects, used for duration of the endoscopy.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
State University of New York - Upstate Medical University
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