Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:1 - 12
Updated:4/21/2016
Start Date:December 2009
End Date:November 2013

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Comparison Of Different Anesthetic Techniques In Children Undergoing Esophagogastroduodenoscopies

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.

Different anesthetic techniques are currently in use at Cincinnati Children's Hospital
Medical Center (CCHMC) for delivering anesthesia during an esophagogastroduodenoscopy (EGD).
Because there is a lack of evidence to delineate the best techniques, pediatric
anesthesiologists select the technique based on clinical preference and experience. One
anesthetic technique involves the use of general anesthesia with the placement of an
endotracheal tube, and maintenance with an inhalation agent, such as sevoflurane (IS). These
patients may be extubated under deep anesthesia in the operating room, and allowed to awaken
in the post anesthesia care unit. A similar technique involves the placement of an
endotracheal tube, and anesthetic maintenance with a continuous infusion of propofol (IP).
These patients are also extubated under deep anesthesia in the operating room, and allowed
to awaken in the postoperative care unit. The third technique does not use an endotracheal
tube and anesthetic maintenance occurs with continuous infusion of propofol with the patient
breathing oxygen through their natural airway (NA). Our objective in this study is to
compare outcomes between these three established anesthetic techniques.

Children in the study will be recruited from Cincinnati Children's Hospital Medical Center
Operating Room Schedule. They will be cared for in the Operating Rooms and Post Anesthesia
Care Unit.

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
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Cincinnati, Ohio 45229
 1-513-636-4200 
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