Clinical trial NCT02038894: Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies
Official title: Comparison Of Different Anesthetic Techniques In Children Undergoing Esophagogastroduodenoscopies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eosinophilic Esophagitis
Keywords: Anesthetic
Pediatric
Esophagogastroduodenoscopies
Eosinophilic esophagitis
Gastroesophageal reflux disease (GERD)
Abdominal Pain
Vomiting
Sevofluorane
Propofol
Nasal cannula
Intubation
Endotracheal tube
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2014-01-17
Enrollment: 179
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Respiratory Complications
timeFrame: Admission for surgery through recovery period, approximately 3 hours
Secondary outcomes:
measure: Peri-operative Times Between Three Different Anesthetic Techniques
timeFrame: Admission for surgery through recovery period, approximately 3 hours
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinati Children's Hospital Medical Center
name: Mario Patino, MD
role: PRINCIPAL_INVESTIGATOR
References:
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