Ketamine Compared to Propofol for Pediatric GI Endoscopy

NCT00614159 | Completed

• 1 other identifier: 5545UMU
• Study Type: observational
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endoscopy

Keywords

Child age 1-10 years having a GI Endoscopy with sedation

Study Arms (1)

GI Endoscopy

Drug: Ketamine; Drug: Propofol

Interventions

Ketamine DRUG

Weight based dosage for Peds subjects, used for duration of the endoscopy.

GI Endoscopy

Propofol DRUG

Weight based dosage for Peds subjects, used for duration of the endoscopy.

GI Endoscopy

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pre-op setting, previously scheduled for GI Endoscopy

You may qualify if:

• Age 1-10
• Endoscopy with sedation scheduled

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

MeSH Terms

Interventions

Ketamine; Propofol

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: October 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: July 2, 2009

Record last verified: 2009-06