Clinical Trials Directory

Trials / Completed

CompletedNCT00614159

Ketamine Compared to Propofol for Pediatric GI Endoscopy

Status
Completed
Phase
Study type
Observational
Enrollment
34 (estimated)
Sponsor
State University of New York - Upstate Medical University · Academic / Other
Sex
All
Age
1 Year – 10 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGKetamineWeight based dosage for Peds subjects, used for duration of the endoscopy.
DRUGPropofolWeight based dosage for Peds subjects, used for duration of the endoscopy.

Timeline

Start date
2007-10-01
Primary completion
2009-06-01
Completion
2009-06-01
First posted
2008-02-13
Last updated
2009-07-02

Source: ClinicalTrials.gov record NCT00614159. Inclusion in this directory is not an endorsement.