Eosinophilic Esophagitis
Conditions
Keywords
Anesthetic, Pediatric, Esophagogastroduodenoscopies, Eosinophilic esophagitis, Gastroesophageal reflux disease (GERD), Abdominal Pain, Vomiting, Sevofluorane, Propofol, Nasal cannula, Intubation, Endotracheal tube
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.
Interventions
DRUGIntubated 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.
DRUGIntubated 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.
DRUGZofran - 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.
DRUGPropofol
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Respiratory Complications | 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
| Measure | Time frame | Description |
|---|---|---|
| Peri-operative Times Between Three Different Anesthetic Techniques | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| 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. | 58 |
| 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 | 61 |
| Total | 179 |
Baseline characteristics
| Characteristic | Intubated With Sevoflurane (IS) | Total | Native Airway - no Intubation | Intubated With Propofol (IP) |
|---|---|---|---|---|
| Age, Continuous | 8 years | 7 years | 7 years | 6 years |
| American Society of Anesthesiologists - ASA Physical Status (Patient's health condition) ASA 1 (Normal healthy subject) | 13 Participants | 38 Participants | 10 Participants | 15 Participants |
| American Society of Anesthesiologists - ASA Physical Status (Patient's health condition) ASA 2 (Mild systemic disease) | 47 Participants | 140 Participants | 50 Participants | 43 Participants |
| American Society of Anesthesiologists - ASA Physical Status (Patient's health condition) Missing or Unknown | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| BMI | 16 kg/m^2 | 16.4 kg/m^2 | 16.6 kg/m^2 | 16.1 kg/m^2 |
| BMI Percent | 46 percentile | 56.8 percentile | 67 percentile | 57.1 percentile |
| Diagnosis Abdominal Pain | 15 Participants | 50 Participants | 15 Participants | 20 Participants |
| Diagnosis Chronic Diarrhea | 3 Participants | 7 Participants | 1 Participants | 3 Participants |
| Diagnosis Diarrhea | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Diagnosis Dysphagia | 4 Participants | 7 Participants | 0 Participants | 3 Participants |
| Diagnosis Eosinophilic esophagitis | 18 Participants | 52 Participants | 24 Participants | 10 Participants |
| Diagnosis Failure to Thrive | 5 Participants | 13 Participants | 5 Participants | 3 Participants |
| Diagnosis Feeding Difficulties | 2 Participants | 3 Participants | 0 Participants | 1 Participants |
| Diagnosis GERD | 6 Participants | 19 Participants | 8 Participants | 5 Participants |
| Diagnosis Nausea/Vomit | 4 Participants | 20 Participants | 7 Participants | 9 Participants |
| Diagnosis Rumination Syndrome | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized African American | 4 Participants | 8 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 3 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 55 Participants | 158 Participants | 51 Participants | 52 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 8 Participants | 6 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 60 Participants | 179 Participants | 61 Participants | 58 Participants |
| Sex: Female, Male Female | 27 Participants | 78 Participants | 26 Participants | 25 Participants |
| Sex: Female, Male Male | 33 Participants | 101 Participants | 35 Participants | 33 Participants |
| Weight | 25 kg | 24.3 kg | 22.5 kg | 22.7 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 60 | 4 / 58 | 24 / 61 |
| serious Total, serious adverse events | 0 / 60 | 1 / 58 | 14 / 61 |
Outcome results
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.
Time frame: Admission for surgery through recovery period, approximately 3 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intubated With Sevoflurane (IS) | Number of Participants With Respiratory Complications | Inadequate Anesthesia | 1 Participants |
| Intubated With Sevoflurane (IS) | Number of Participants With Respiratory Complications | SPO2 < 95% | 0 Participants |
| Intubated With Sevoflurane (IS) | Number of Participants With Respiratory Complications | All Respiratory Events | 2 Participants |
| Intubated With Sevoflurane (IS) | Number of Participants With Respiratory Complications | SPO2 < 85% | 0 Participants |
| Intubated With Sevoflurane (IS) | Number of Participants With Respiratory Complications | Apnea | 0 Participants |
| Intubated With Propofol (IP) | Number of Participants With Respiratory Complications | Inadequate Anesthesia | 4 Participants |
| Intubated With Propofol (IP) | Number of Participants With Respiratory Complications | Apnea | 1 Participants |
| Intubated With Propofol (IP) | Number of Participants With Respiratory Complications | SPO2 < 85% | 0 Participants |
| Intubated With Propofol (IP) | Number of Participants With Respiratory Complications | All Respiratory Events | 5 Participants |
| Intubated With Propofol (IP) | Number of Participants With Respiratory Complications | SPO2 < 95% | 0 Participants |
| Native Airway - no Intubation | Number of Participants With Respiratory Complications | Apnea | 5 Participants |
| Native Airway - no Intubation | Number of Participants With Respiratory Complications | SPO2 < 95% | 15 Participants |
| Native Airway - no Intubation | Number of Participants With Respiratory Complications | SPO2 < 85% | 9 Participants |
| Native Airway - no Intubation | Number of Participants With Respiratory Complications | Inadequate Anesthesia | 9 Participants |
| Native Airway - no Intubation | Number of Participants With Respiratory Complications | All Respiratory Events | 28 Participants |
| IS and IP | Number of Participants With Respiratory Complications | All Respiratory Events | 7 Participants |
| IS and IP | Number of Participants With Respiratory Complications | SPO2 < 95% | 0 Participants |
| IS and IP | Number of Participants With Respiratory Complications | Inadequate Anesthesia | 5 Participants |
| IS and IP | Number of Participants With Respiratory Complications | Apnea | 1 Participants |
| IS and IP | Number of Participants With Respiratory Complications | SPO2 < 85% | 0 Participants |
| IP and NA | Number of Participants With Respiratory Complications | Apnea | 5 Participants |
| IP and NA | Number of Participants With Respiratory Complications | Inadequate Anesthesia | 13 Participants |
| IP and NA | Number of Participants With Respiratory Complications | SPO2 < 95% | 15 Participants |
| IP and NA | Number of Participants With Respiratory Complications | All Respiratory Events | 32 Participants |
| IP and NA | Number of Participants With Respiratory Complications | SPO2 < 85% | 8 Participants |
p-value: <0.000195% CI: [0, 0.14]Mean equality test
p-value: 0.000195% CI: [0, 0.27]Mean equality test
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.
Time frame: Admission for surgery through recovery period, approximately 3 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intubated With Sevoflurane (IS) | Peri-operative Times Between Three Different Anesthetic Techniques | PACU efficiency time | 49.50 Minutes | Standard Deviation 14.31 |
| Intubated With Sevoflurane (IS) | Peri-operative Times Between Three Different Anesthetic Techniques | OR Time | 24.03 Minutes | Standard Deviation 6 |
| Intubated With Sevoflurane (IS) | Peri-operative Times Between Three Different Anesthetic Techniques | Total Perioperative Time | 75.34 Minutes | Standard Deviation 15.4 |
| Intubated With Sevoflurane (IS) | Peri-operative Times Between Three Different Anesthetic Techniques | Anesthesia Preparation Time | 10.86 Minutes | Standard Deviation 2.53 |
| Intubated With Sevoflurane (IS) | Peri-operative Times Between Three Different Anesthetic Techniques | Procedural Time | 9.07 Minutes | Standard Deviation 4.78 |
| Intubated With Propofol (IP) | Peri-operative Times Between Three Different Anesthetic Techniques | PACU efficiency time | 53.49 Minutes | Standard Deviation 12.68 |
| Intubated With Propofol (IP) | Peri-operative Times Between Three Different Anesthetic Techniques | Procedural Time | 9.23 Minutes | Standard Deviation 5.46 |
| Intubated With Propofol (IP) | Peri-operative Times Between Three Different Anesthetic Techniques | Anesthesia Preparation Time | 10.70 Minutes | Standard Deviation 2.7 |
| Intubated With Propofol (IP) | Peri-operative Times Between Three Different Anesthetic Techniques | Total Perioperative Time | 79.61 Minutes | Standard Deviation 14.45 |
| Intubated With Propofol (IP) | Peri-operative Times Between Three Different Anesthetic Techniques | OR Time | 24.19 Minutes | Standard Deviation 7.54 |
| Native Airway - no Intubation | Peri-operative Times Between Three Different Anesthetic Techniques | Procedural Time | 8.33 Minutes | Standard Deviation 4.18 |
| Native Airway - no Intubation | Peri-operative Times Between Three Different Anesthetic Techniques | OR Time | 23.05 Minutes | Standard Deviation 7.97 |
| Native Airway - no Intubation | Peri-operative Times Between Three Different Anesthetic Techniques | Anesthesia Preparation Time | 10.35 Minutes | Standard Deviation 3.35 |
| Native Airway - no Intubation | Peri-operative Times Between Three Different Anesthetic Techniques | PACU efficiency time | 54.42 Minutes | Standard Deviation 22.59 |
| Native Airway - no Intubation | Peri-operative Times Between Three Different Anesthetic Techniques | Total Perioperative Time | 79.37 Minutes | Standard Deviation 25.17 |
| IS and IP | Peri-operative Times Between Three Different Anesthetic Techniques | Total Perioperative Time | 77.46 Minutes | Standard Deviation 15.03 |
| IS and IP | Peri-operative Times Between Three Different Anesthetic Techniques | OR Time | 24.11 Minutes | Standard Deviation 6.77 |
| IS and IP | Peri-operative Times Between Three Different Anesthetic Techniques | PACU efficiency time | 51.48 Minutes | Standard Deviation 13.61 |
| IS and IP | Peri-operative Times Between Three Different Anesthetic Techniques | Procedural Time | 9.15 Minutes | Standard Deviation 5.11 |
| IS and IP | Peri-operative Times Between Three Different Anesthetic Techniques | Anesthesia Preparation Time | 10.78 Minutes | Standard Deviation 2.6 |
| IP and NA | Peri-operative Times Between Three Different Anesthetic Techniques | Procedural Time | 8.78 Minutes | Standard Deviation 4.86 |
| IP and NA | Peri-operative Times Between Three Different Anesthetic Techniques | PACU efficiency time | 53.96 Minutes | Standard Deviation 18.24 |
| IP and NA | Peri-operative Times Between Three Different Anesthetic Techniques | OR Time | 23.61 Minutes | Standard Deviation 7.75 |
| IP and NA | Peri-operative Times Between Three Different Anesthetic Techniques | Total Perioperative Time | 79.49 Minutes | Standard Deviation 20.43 |
| IP and NA | Peri-operative Times Between Three Different Anesthetic Techniques | Anesthesia Preparation Time | 10.53 Minutes | Standard Deviation 3.03 |
Comparison: Total OR Timep-value: 0.901Mean equality test