Overview
Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies
Status:
Completed
Completed
Trial end date:
2013-11-01
2013-11-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
N/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Children's Hospital Medical Center, CincinnatiTreatments:
Anesthetics
Ondansetron
Propofol
Sevoflurane
Criteria
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, tracheomalacia, tracheostomy)
- Patients with history of obstructive sleep apnea
- Patient receiving sedative premedication
- Patient previously treated under this protocol
- Patients with symptoms of an active upper respiratory infection
- Patients with history of coagulopathy
- Patients with esophageal varices or gastrointestinal bleeding