Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies

September 23, 2020 updated by: Children's Hospital Medical Center, Cincinnati

Comparison Of Different Anesthetic Techniques In Children Undergoing Esophagogastroduodenoscopies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intubated with Sevoflurane (IS)
Anesthetic technique during (EGD)
Drug: Intubated with Sevoflurane (IS)
Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia.
ACTIVE_COMPARATOR: Intubated with Propofol (IP)
Anesthetic technique during (EGD)
Drug: Intubated with Propofol (IP)
Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia.
ACTIVE_COMPARATOR: Native Airway - no intubation
Anesthetic technique during (EGD)
Drug: Propofol
Drug: Zofran - no intubation
A nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Respiratory Complications
Time Frame: Admission for surgery through recovery period, approximately 3 hours
An important outcome in the anesthetic management of these patients is to maintain a balance between a safe technique with a minimal incidence of respiratory complications, and a technique that facilitates rapid turnover of the gastrointestinal suite. A chi-square test, or Fisher's exact test will measure differences among the three anesthetic groups. Different anesthetic techniques are currently in use at Cincinnati Children's Hospital Medical Center (CCHMC). Because there is a lack of evidence to delineate the best techniques, pediatric anesthesiologists select the technique based on clinical preference and experience.
Admission for surgery through recovery period, approximately 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-operative Times Between Three Different Anesthetic Techniques
Time Frame: Admission for surgery through recovery period, approximately 3 hours
Time measurements are used to evaluate the efficiency of the different techniques. We will compare the times spent in the operating room and the postoperative unit for each technique.
Admission for surgery through recovery period, approximately 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Mario Patino, MD, Cincinati Children's Hospital Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

May 1, 2013

First Submitted That Met QC Criteria

January 16, 2014

First Posted (ESTIMATE)

January 17, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2020

Last Update Submitted That Met QC Criteria

September 23, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-0100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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