Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies
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About
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.
Full description
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.
Enrollment
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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, 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
179 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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