- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00614159
Ketamine Compared to Propofol for Pediatric GI Endoscopy
June 30, 2009 updated by: State University of New York - Upstate Medical University
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.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
34
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Pre-op setting, previously scheduled for GI Endoscopy
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
GI Endoscopy
|
Weight based dosage for Peds subjects, used for duration of the endoscopy.
Weight based dosage for Peds subjects, used for duration of the endoscopy.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
January 31, 2008
First Submitted That Met QC Criteria
February 12, 2008
First Posted (Estimate)
February 13, 2008
Study Record Updates
Last Update Posted (Estimate)
July 2, 2009
Last Update Submitted That Met QC Criteria
June 30, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Hypnotics and Sedatives
- Ketamine
- Propofol
Other Study ID Numbers
- 5545UMU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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