Ketamine Compared to Propofol for Pediatric GI Endoscopy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Endoscopy |
Drug: Ketamine Drug: Propofol |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Estimated Enrollment: | 34 |
| Study Start Date: | October 2007 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| GI Endoscopy |
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.
|
Eligibility| Ages Eligible for Study: | 1 Year to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Pre-op setting, previously scheduled for GI Endoscopy
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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Xiuli Zhang, MD, Upstate Medical University |
| ClinicalTrials.gov Identifier: | NCT00614159 History of Changes |
| Other Study ID Numbers: | 5545UMU |
| Study First Received: | January 31, 2008 |
| Last Updated: | June 30, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by State University of New York - Upstate Medical University:
|
Child age 1-10 years having a GI Endoscopy with sedation |
Additional relevant MeSH terms:
|
Ketamine Propofol Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on May 22, 2013