Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-20 @ 7:30 AM
Study NCT ID:
NCT00614159
Status:
COMPLETED
Last Update Posted:
2009-07-02
First Post:
2008-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketamine Compared to Propofol for Pediatric GI Endoscopy
Sponsor:
State University of New York - Upstate Medical University
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: