Sedation Complication, Endoscopic Submucosal Dissection, Esophagogastroduodenoscopy
Conditions
Keywords
Etomidate, Propofol
Brief summary
During endoscopy, the patient is sedated to relieve pain and improve the ease of the procedure. Sedation endoscopy using propofol is effective, but has the disadvantage that cardiopulmonary side effects are frequently observed. However, etomidate is known to have hemodynamic and respiratory stability.The purpose of this study was to compare the efficacy and safety of etomidate and propofol in sedated gastric endoscopic submucosal dissection.
Interventions
DRUGEtomidate Injection
Proofol and etomidate are drugs used for sedation and have the same white color. Gastric endoscopic submucosal dissection is performed using propofol in the control group and etomidate in the experimental group. Efficacy and safety of sedatives were confirmed using propofol and etomidate.
Proofol and etomidate are drugs used for sedation and have the same white color. Gastric endoscopic submucosal dissection is performed using propofol in the control group and etomidate in the experimental group. Efficacy and safety of sedatives were confirmed using propofol and etomidate.
Sponsors
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 19-80 * American Society of Anesthesiologists Physical Status Classification System (ASA) score of I, II, III * Scheduled endoscopy
Exclusion criteria
* Pregnancy * Previous study History of hypersensitivity to drugs or substances containing soy or egg ingredients * Those who think that tracheal intubation will be difficult * Obstructive sleep apnea * History of side effects from previous sedatives * People with severe liver disease, kidney disease, or heart disease * Those who want a non-sleeping endoscope * A person who refuses to provide consent * SBP < 80mmHg or SpO2 < 90% * Patients with adrenocortical dysfunction, chronic steroid users
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory adverse event | during gastric endoscopic submucosal dissection | the number and proportion of cases of respiratory depression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events and procedure interruptions | during gastric endoscopic submucosal dissection | Overall adverse events Cardiopulmonary adverse events Procedure-related adverse events Overall procedure interruption procedure interruption due to cardiopulmonary adverse events procedure interruption due to procedure-related adverse events |
| Sedation-related profile | From initial administering the sedative drug to endoscopy room discharge (up to 2 hours); dose (ml) | administered dose of sedatives (induction dose, maintenance dose, total dose), induction time, awake time, sedation time |
| ESD clinical outcomes | From enrollment to the first clinic visit (within 60 days) | tumor location, tumor pathology, ESD specimen size, En-bloc resection, submucosal invasion, margin positive |
| Hemodynamic changes | From date of randomization until the date of first documented progression (up to 2 hours) | systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, heart rate, oxygen saturation |
| Factors associated with adverse events | From date of randomization until the date of first documented progression (up to three days) | factor analysis regarding overall adverse events factor analysis regarding overall cardiopulmonary adverse events factor analysis regarding overall procedure adverse events |
| Satisfaction assessment | From initial administering the sedative drug to endoscopy room discharge; satisfaction score (0-10, 10 is the highest score) | patient satisfaction regarding sedation, doctor and nurse satisfaction regarding sedation during ESD |
Countries
South Korea
Outcome results
None listed