Ketamine Compared to Propofol for Pediatric GI Endoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy

NCT02062177

Sedation Endoscopy

COMPLETED PHASE4

The Efficacy of Midazolam & Ketamine Versus Midazolam & Fentanyl for Sedation in Ambulatory Colonoscopies

NCT00376831

Colonoscopy Conscious Sedation

COMPLETED PHASE4

EEG-guided Propofol Sedation Versus Standard Care for Oesophagogastroduodenoscopy and Colonoscopy in Children

NCT06225037

Anesthesia Anesthesia; Adverse Effect Anesthesia Emergence Delirium +2 more

COMPLETED NA

Esketamine and Propofol for Children With Autism Spectrum Disorder Undergoing Colonoscopy

NCT05951465

Autism Spectrum Disorder

COMPLETED NA

Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy

NCT03369197

Hypoxia Endoscopy Anesthesia Morbidity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GI Endoscopy

Ketamine

Intervention Type DRUG

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

Propofol

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketamine

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

Intervention Type DRUG

Propofol

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No