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Completed

NCT Number: NCT02038894

Comparing Anesthetic Techniques in Children Having 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intubated with Sevoflurane (IS)

Drug

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.

Intubated with Propofol (IP)

Drug

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.

Zofran - no intubation

Drug

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.

Propofol

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Comparison Of Different Anesthetic Techniques In Children Undergoing Esophagogastroduodenoscopies

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 17, 2014
Registry last updated
Sep 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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