Efficacy and Safety of Etomidate Sedation in Gastric Endoscopic Submucosal Dissection

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Sedation Complication, Endoscopic Submucosal Dissection, Esophagogastroduodenoscopy

Intervention / Treatment
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* Drug: Etomidate Injection
* Drug: Propofol Injection


Participation Criteria
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Eligibility Criteria
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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 Clinically unstable procedure situations (more than grade 3 myoclonus, paradoxical movement, uncontrolled vital sign.. etc)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>induction - 0.5mg/kg Propofol maintenance - 0.25mg/kg Propofol | Drug: Propofol Injection<br>* 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.<br>|
| Experimental: Etomidate<br>induction - 0.25mg/kg Propofol + 0.05mg/kg Etomidate maintenance - 0.05mg/kg Etomidate | Drug: Etomidate Injection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory depressive event | the number and proportion of cases of respiratory depression | during gastric endoscopic submucosal dissection | 
| All overall adverse event events including cardiopulmonary adverse events | the number and proportion of adverse event events including cardiopulmonary adverse events | during gastric endoscopic submucosal dissection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Etomidate, Propofol