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N/A N=179 Randomized Single-blind Prevention

Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies

Eosinophilic Esophagitis

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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