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Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02038894
Recruitment Status : Completed
First Posted : January 17, 2014
Results First Posted : September 24, 2020
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Drug: Intubated with Sevoflurane (IS) Drug: Intubated with Propofol (IP) Drug: Zofran - no intubation Drug: Propofol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Comparison Of Different Anesthetic Techniques In Children Undergoing Esophagogastroduodenoscopies
Study Start Date : December 2009
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

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: 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.

Drug: Propofol



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038894


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Mario Patino, MD Cincinati Children's Hospital Medical Center
Publications of Results:
Other Publications:
U.S Food and Drug Administration. Med Watch. The FDA Safety Information and AdverseReportingProgram.Availableat:http://www.fda.gov/medWatch/report/DESK/advevnt.htm

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02038894    
Other Study ID Numbers: 2009-0100
First Posted: January 17, 2014    Key Record Dates
Results First Posted: September 24, 2020
Last Update Posted: September 24, 2020
Last Verified: September 2020
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Anesthetic
Pediatric
Esophagogastroduodenoscopies
Eosinophilic esophagitis
Gastroesophageal reflux disease (GERD)
Abdominal Pain
Vomiting
Sevofluorane
Propofol
Nasal cannula
Intubation
Endotracheal tube
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation