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Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies

Primary Purpose

Eosinophilic Esophagitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intubated with Sevoflurane (IS)

Intubated with Propofol (IP)

Zofran - no intubation

Propofol

About this trial

This is an interventional prevention trial for Eosinophilic Esophagitis focused on measuring Anesthetic, Pediatric, Esophagogastroduodenoscopies, Eosinophilic esophagitis, Gastroesophageal reflux disease (GERD), Abdominal Pain, Vomiting, Sevofluorane, Propofol, Nasal cannula, Intubation, Endotracheal tube

Eligibility Criteria

1 Year - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Intubated with Sevoflurane (IS)

Intubated with Propofol (IP)

Native Airway - no intubation

Arm Description

Anesthetic technique during (EGD)

Outcomes

Primary Outcome Measures

Number of Participants With Respiratory Complications

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.

Secondary Outcome Measures

Peri-operative Times Between Three Different Anesthetic Techniques

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.

Full Information

NCT ID

NCT02038894

First Posted

May 1, 2013

Last Updated

September 23, 2020

Sponsor

Children's Hospital Medical Center, Cincinnati

1. Study Identification

Unique Protocol Identification Number

NCT02038894

Brief Title

Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies

Official Title

Comparison Of Different Anesthetic Techniques In Children Undergoing Esophagogastroduodenoscopies

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital Medical Center, Cincinnati

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eosinophilic Esophagitis

Keywords

Anesthetic, Pediatric, Esophagogastroduodenoscopies, Eosinophilic esophagitis, Gastroesophageal reflux disease (GERD), Abdominal Pain, Vomiting, Sevofluorane, Propofol, Nasal cannula, Intubation, Endotracheal tube

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

179 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intubated with Sevoflurane (IS)

Arm Type

Active Comparator

Arm Description

Anesthetic technique during (EGD)

Arm Title

Intubated with Propofol (IP)

Arm Type

Active Comparator

Arm Description

Anesthetic technique during (EGD)

Arm Title

Native Airway - no intubation

Arm Type

Active Comparator

Arm Description

Anesthetic technique during (EGD)

Intervention Type

Drug

Intervention Name(s)

Intubated with Sevoflurane (IS)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Intubated with Propofol (IP)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Zofran - no intubation

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Propofol

Primary Outcome Measure Information:

Title

Number of Participants With Respiratory Complications

Description

Time Frame

Admission for surgery through recovery period, approximately 3 hours

Secondary Outcome Measure Information:

Title

Peri-operative Times Between Three Different Anesthetic Techniques

Description

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.

Time Frame

Admission for surgery through recovery period, approximately 3 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mario Patino, MD

Organizational Affiliation

Cincinati Children's Hospital Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20716074

Citation

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Results Reference

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Citation

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Results Reference

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Citation

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Citation

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Citation

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Citation

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Results Reference

result

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Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies

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