Efficacy and Safety of Etomidate Sedation in Gastric Endoscopic Submucosal Dissection

Korea University Anam Hospital138 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

138

Conditions

Sedation Complication Endoscopic Submucosal Dissection Esophagogastroduodenoscopy

Interventions

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.

Propofol InjectionDRUG

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Respiratory adverse event

the number and proportion of cases of respiratory depression

Time frame: during gastric endoscopic submucosal dissection

Secondary Outcomes

ESD clinical outcomes

tumor location, tumor pathology, ESD specimen size, En-bloc resection, submucosal invasion, margin positive

Time frame: From enrollment to the first clinic visit (within 60 days)

Adverse events and procedure interruptions

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

Time frame: during gastric endoscopic submucosal dissection

Sedation-related profile

administered dose of sedatives (induction dose, maintenance dose, total dose), induction time, awake time, sedation time

Time frame: From initial administering the sedative drug to endoscopy room discharge (up to 2 hours); dose (ml)

Satisfaction assessment

patient satisfaction regarding sedation, doctor and nurse satisfaction regarding sedation during ESD

Time frame: From initial administering the sedative drug to endoscopy room discharge; satisfaction score (0-10, 10 is the highest score)

Hemodynamic changes

systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, heart rate, oxygen saturation

Time frame: From date of randomization until the date of first documented progression (up to 2 hours)

Factors associated with adverse events

factor analysis regarding overall adverse events factor analysis regarding overall cardiopulmonary adverse events factor analysis regarding overall procedure adverse events

Time frame: From date of randomization until the date of first documented progression (up to three days)