Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies

NCT02038894 | Completed Results

• 1 other identifier: 2009-0100
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Admission for surgery through recovery period, approximately 3 hours

Secondary Outcomes (1)

• Peri-operative Times Between Three Different Anesthetic Techniques

  Admission for surgery through recovery period, approximately 3 hours

Study Arms (3)

Intubated with Sevoflurane (IS)

ACTIVE COMPARATOR

Anesthetic technique during (EGD)

Drug: Intubated with Sevoflurane (IS)

Intubated with Propofol (IP)

ACTIVE COMPARATOR

Anesthetic technique during (EGD)

Drug: Intubated with Propofol (IP)

Native Airway - no intubation

ACTIVE COMPARATOR

Anesthetic technique during (EGD)

Drug: Zofran - no intubation; Drug: Propofol

Interventions

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 Sevoflurane (IS)

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.

Intubated with Propofol (IP)

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.

Native Airway - no intubation

Propofol DRUG

Native Airway - no intubation

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (12)

• Hoffmann CO, Samuels PJ, Beckman E, Hein EA, Shackleford TM, Overbey E, Berlin RE, Wang Y, Nick TG, Gunter JB. Insufflation vs intubation during esophagogastroduodenoscopy in children. Paediatr Anaesth. 2010 Sep;20(9):821-30. doi: 10.1111/j.1460-9592.2010.03357.x.

  PMID: 20716074 BACKGROUND

• Brown RH, Wagner EM. Mechanisms of bronchoprotection by anesthetic induction agents: propofol versus ketamine. Anesthesiology. 1999 Mar;90(3):822-8. doi: 10.1097/00000542-199903000-00025.

  PMID: 10078684 BACKGROUND

• Oberer C, von Ungern-Sternberg BS, Frei FJ, Erb TO. Respiratory reflex responses of the larynx differ between sevoflurane and propofol in pediatric patients. Anesthesiology. 2005 Dec;103(6):1142-8. doi: 10.1097/00000542-200512000-00007.

  PMID: 16306725 BACKGROUND

• Schwartz DA, Connelly NR, Theroux CA, Gibson CS, Ostrom DN, Dunn SM, Hirsch BZ, Angelides AG. Gastric contents in children presenting for upper endoscopy. Anesth Analg. 1998 Oct;87(4):757-60. doi: 10.1097/00000539-199810000-00003.

  PMID: 9768765 BACKGROUND

• Lightdale JR, Mahoney LB, Schwarz SM, Liacouras CA. Methods of sedation in pediatric endoscopy: a survey of NASPGHAN members. J Pediatr Gastroenterol Nutr. 2007 Oct;45(4):500-2. doi: 10.1097/MPG.0b013e3180691168.

  PMID: 18030225 BACKGROUND

• Elitsur Y, Blankenship P, Lawrence Z. Propofol sedation for endoscopic procedures in children. Endoscopy. 2000 Oct;32(10):788-91. doi: 10.1055/s-2000-7713.

  PMID: 11068839 BACKGROUND

• Cravero JP, Blike GT, Beach M, Gallagher SM, Hertzog JH, Havidich JE, Gelman B; Pediatric Sedation Research Consortium. Incidence and nature of adverse events during pediatric sedation/anesthesia for procedures outside the operating room: report from the Pediatric Sedation Research Consortium. Pediatrics. 2006 Sep;118(3):1087-96. doi: 10.1542/peds.2006-0313.

  PMID: 16951002 BACKGROUND

• Tosun Z, Aksu R, Guler G, Esmaoglu A, Akin A, Aslan D, Boyaci A. Propofol-ketamine vs propofol-fentanyl for sedation during pediatric upper gastrointestinal endoscopy. Paediatr Anaesth. 2007 Oct;17(10):983-8. doi: 10.1111/j.1460-9592.2007.02206.x.

  PMID: 17767636 BACKGROUND

• Thakkar K, El-Serag HB, Mattek N, Gilger MA. Complications of pediatric EGD: a 4-year experience in PEDS-CORI. Gastrointest Endosc. 2007 Feb;65(2):213-21. doi: 10.1016/j.gie.2006.03.015.

  PMID: 17258979 BACKGROUND

• Kaddu R, Bhattacharya D, Metriyakool K, Thomas R, Tolia V. Propofol compared with general anesthesia for pediatric GI endoscopy: is propofol better? Gastrointest Endosc. 2002 Jan;55(1):27-32. doi: 10.1067/mge.2002.120386.

  PMID: 11756910 BACKGROUND

• U.S Food and Drug Administration. Med Watch. The FDA Safety Information and AdverseReportingProgram.Availableat:http://www.fda.gov/medWatch/report/DESK/advevnt.htm

  BACKGROUND

• Patino M, Glynn S, Soberano M, Putnam P, Hossain MM, Hoffmann C, Samuels P, Kibelbek MJ, Gunter J. Comparison of different anesthesia techniques during esophagogastroduedenoscopy in children: a randomized trial. Paediatr Anaesth. 2015 Oct;25(10):1013-9. doi: 10.1111/pan.12717. Epub 2015 Jul 17.

  PMID: 26184697 RESULT

MeSH Terms

Conditions

Eosinophilic Esophagitis; Gastroesophageal Reflux; Abdominal Pain; Vomiting

Interventions

Sevoflurane; Propofol

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Limitations and Caveats

prior to conclusion. THis is optional

Results Point of Contact

• Title: Dr. Mario Patino
• Organization: Cincinnati Children's Hospital Medical Center

mario.patino@cchcm.org

5132538190

Study Officials

• Mario Patino, MD

  Cincinati Children's Hospital Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: January 17, 2014
• Study Start: December 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: September 24, 2020
• Results First Posted: September 24, 2020

Record last verified: 2020-09

Locations

US (1)