A Comparative Study of the Efficacy and Safety of Etomidate Compared to Propofol in Gastric Endoscopic Submucosal Dissection: a Prospective, Single-center, Randomized, Double-blind, Non-inferiority Study
Overview
- Phase
- N/A
- Intervention
- Propofol Injection
- Conditions
- Sedation Complication
- Sponsor
- Korea University Anam Hospital
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- Respiratory adverse event
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Keum, Bo Ra
Professor
Korea University Anam Hospital
Eligibility Criteria
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
Arms & Interventions
Propofol
induction - 0.5mg/kg Propofol maintenance - 0.25mg/kg Propofol
Intervention: Propofol Injection
Etomidate
induction - 0.25mg/kg Propofol + 0.05mg/kg Etomidate maintenance - 0.05mg/kg Etomidate
Intervention: Etomidate Injection
Outcomes
Primary Outcomes
Respiratory adverse event
Time Frame: during gastric endoscopic submucosal dissection
the number and proportion of cases of respiratory depression
Secondary Outcomes
- ESD clinical outcomes(From enrollment to the first clinic visit (within 60 days))
- Adverse events and procedure interruptions(during gastric endoscopic submucosal dissection)
- Sedation-related profile(From initial administering the sedative drug to endoscopy room discharge (up to 2 hours); dose (ml))
- Satisfaction assessment(From initial administering the sedative drug to endoscopy room discharge; satisfaction score (0-10, 10 is the highest score))
- Hemodynamic changes(From date of randomization until the date of first documented progression (up to 2 hours))
- Factors associated with adverse events(From date of randomization until the date of first documented progression (up to three days))