Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies

Completed · Not applicable

Conditions studied: Eosinophilic Esophagitis

In brief

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.

Key facts

Study ID

NCT02038894

Run by

Children's Hospital Medical Center, Cincinnati

People needed

179

Starts

2009-12-01

Expected to finish

2013-11-01

Last updated by the study team

2020-09-24

Who can join

Age: 1 and older, up to 12. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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