Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02038894
• Date of registration: 01/05/2013
• Prospective Registration: No
• Primary sponsor: Children's Hospital Medical Center, Cincinnati
• Public title: Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies
• Scientific title: Comparison Of Different Anesthetic Techniques In Children Undergoing Esophagogastroduodenoscopies
• Date of first enrolment: December 2009
• Target sample size: 179
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02038894
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Mario Patino, MD
• Affiliation: Cincinati Children's Hospital Medical Center

Key inclusion & exclusion 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



Age minimum: 1 Year
Age maximum: 12 Years
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis

Intervention(s)

Drug: Intubated with Propofol (IP)

Drug: Zofran - no intubation

Drug: Intubated with Sevoflurane (IS)

Drug: Propofol

Primary Outcome(s)

Number of Participants With Respiratory Complications [Time Frame: Admission for surgery through recovery period, approximately 3 hours]

Secondary Outcome(s)

Peri-operative Times Between Three Different Anesthetic Techniques [Time Frame: Admission for surgery through recovery period, approximately 3 hours]

Secondary ID(s)

2009-0100

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/09/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02038894