N/A
N=179
Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies
Eosinophilic Esophagitis
Bottom Line
View on ClinicalTrials.gov: NCT02038894 ↗Enrolled (actual)
179
Serious AEs
8.4%
Results posted
Sep 2020
Primary outcome: Primary: Number of Participants With Respiratory Complications — 0; 0; 15; 0 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intubated with Sevoflurane (IS) (Drug); Intubated with Propofol (IP) (Drug); Zofran - no intubation (Drug); Propofol (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Respiratory Complications |
0; 0; 15; 0; 15; 0 | <0.0001 sig |
| SECONDARY Peri-operative Times Between Three Different Anesthetic Techniques |
24.03; 24.19; 23.05; 24.11; 23.61; 10.86 | 0.901 |
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.
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
Data sourced from ClinicalTrials.gov (NCT02038894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.