Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies (NCT02038894) | Clinical Trial Compass
CompletedNot Applicable
Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies
United States179 participantsStarted 2009-12
Plain-language summary
The purpose of this research study is to compare the safety and effectiveness of three commonly used techniques for delivering anesthesia during a procedure known as esophagogastroduodenoscopy.
Who can participate
Age range1 Year – 12 Years
SexALL
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Inclusion Criteria:
* Patient presenting as out-patients, scheduled to receive an anesthetic for a diagnostic EGD
* Patient must be a candidate for any of the three anesthetic techniques. This decision will be made by a staff member of the Department of Anesthesiology, who is not a member of the study team and will be responsible for obtaining consent for anesthesia
* Patient must be between ages 1 and 12 years (inclusive)
* Patient must be American Society of Anesthesiology (ASA) class I or II;
* Eosinophilic esophagitis (EE) patients classified as an ASA III status for their EE diagnosis only
* Patient must have fasted according to CCHMC policy
* Patient's legally authorized representative has given written informed consent to participate in the study and, when appropriate, the subject has given assent to participate
Exclusion Criteria:
* Patients less than a year old and greater than 12 years old
* Patients undergoing therapeutic upper endoscopy
* Patients with an ASA physical status III or greater (other than EE patients)
* Patients with history of allergy to propofol, any other drug in the protocol, or eggs (exclusive of egg allergies identified only by skin testing or manifested only by gastrointestinal symptoms)
* Patients with personal or family history of malignant hyperthermia
* Obese patients (Body mass index more than 95th percentile for age)
* Patients with significant airway abnormalities (e.g., trisomy 21, craniofacial syndromes, sub-glottic stenosis, trache…
What they're measuring
1
Number of Participants With Respiratory Complications
Timeframe: Admission for surgery through recovery period, approximately 3 hours
Trial details
NCT IDNCT02038894
SponsorChildren's Hospital Medical Center, Cincinnati