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Sponsored by: |
State University of New York - Upstate Medical University |
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Information provided by: | State University of New York - Upstate Medical University |
ClinicalTrials.gov Identifier: | NCT00614159 |
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 |
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Endoscopy |
Drug: Ketamine Drug: Propofol |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Estimated Enrollment: | 34 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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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.
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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:
Exclusion Criteria:
Contact: Kimberly A Kasprowicz, MS,RN,FNP | 315-464-4892 | kasprowk@upstate.edu |
United States, New York | |
Upstate Medical University | Recruiting |
Syracuse, New York, United States, 13210 | |
Contact: Kimberly A Kasprowicz, MS, RN, FNP 315-464-4892 kasprowk@upstate.edu |
Responsible Party: | Upstate Medical University ( Xiuli Zhang, MD ) |
Study ID Numbers: | 5545UMU |
Study First Received: | January 31, 2008 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00614159 |
Health Authority: | United States: Institutional Review Board |
Child age 1-10 years having a GI Endoscopy with sedation |
Excitatory Amino Acids Ketamine Propofol |
Anesthetics, Intravenous Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Excitatory Amino Acid Agents Anesthetics, Dissociative Pharmacologic Actions |
Sensory System Agents Anesthetics, General Therapeutic Uses Hypnotics and Sedatives Peripheral Nervous System Agents Analgesics Central Nervous System Agents Excitatory Amino Acid Antagonists |