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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intubated with Sevoflurane (IS) | Active Comparator | Anesthetic technique during (EGD) |
|
| Intubated with Propofol (IP) | Active Comparator | Anesthetic technique during (EGD) |
|
| Native Airway - no intubation | Active Comparator | Anesthetic technique during (EGD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Admission for surgery through recovery period, approximately 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mario Patino, MD | Cincinati Children's Hospital Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20716074 | Background | 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. | |
| 10078684 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intubated With Sevoflurane (IS) | Anesthetic technique during (EGD) 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. |
| FG001 | Intubated With Propofol (IP) | Anesthetic technique during (EGD) 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. |
| FG002 | Native Airway - no Intubation | Anesthetic technique during (EGD) 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. Propofol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intubated With Sevoflurane (IS) | Anesthetic technique during (EGD) 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Admission for surgery through recovery period, approximately 3 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intubated With Sevoflurane (IS) | Anesthetic technique during (EGD) 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe desaturation: SpO2 < 85% | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | A recorded SpO2 < 85% during the anesthesia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor desaturation < 95% | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
prior to conclusion. THis is optional
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mario Patino | Cincinnati Children's Hospital Medical Center | 5132538190 | mario.patino@cchcm.org |
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| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| D005764 | Gastroesophageal Reflux |
| D015746 | Abdominal Pain |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
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|
| 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 |
|
| 16306725 | 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. |
| 9768765 | 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. |
| 18030225 | 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. |
| 11068839 | 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. |
| 16951002 | 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. |
| 17767636 | 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. |
| 17258979 | 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. |
| 11756910 | 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. |
| 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 |
| 26184697 | Result | 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. |
| BG001 | Intubated With Propofol (IP) | Anesthetic technique during (EGD) 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. |
| BG002 | Native Airway - no Intubation | Anesthetic technique during (EGD) 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. Propofol |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Weight | Median | Inter-Quartile Range | kg |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
| BMI Percent | Median | Inter-Quartile Range | percentile |
|
| American Society of Anesthesiologists - ASA Physical Status (Patient's health condition) | Count of Participants | Participants |
|
| Diagnosis | Count of Participants | Participants |
|
| OG001 | Intubated With Propofol (IP) | Anesthetic technique during (EGD) 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. |
| OG002 | Native Airway - no Intubation | Anesthetic technique during (EGD) 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. Propofol |
| OG003 | IS and IP | Grouping the intubated with sevoflurane group (IS) with the intubated with propofol group (IP) since the airway management is the same for both groups (endotracheal intubation) Table 2 |
| OG004 | IP and NA | Grouping the intubated propofol group (IP) with the native airway group (NA) since they received the same medication during the procedure (propofol). Table 2 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Minutes | Admission for surgery through recovery period, approximately 3 hours |
|
|
|
|
| 0 |
| 60 |
| 1 |
| 60 |
| EG001 | Intubated With Propofol (IP) | Anesthetic technique during (EGD) 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. | 1 | 58 | 4 | 58 |
| EG002 | Native Airway - no Intubation | Anesthetic technique during (EGD) 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. Propofol | 14 | 61 | 24 | 61 |
|
| Apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Inadequate anesthesia | Surgical and medical procedures | Systematic Assessment |
|
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| D005759 |
| Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| Anesthesia Preparation Time |
|
| Procedural Time |
|
| PACU efficiency time |
|
| Total Perioperative Time |
|