Efficacy and Safety of Etomidate Sedation in Gastric Endoscopic Submucosal Dissection

Not Applicable

Completed

• Conditions: Sedation Complication; Endoscopic Submucosal Dissection; Esophagogastroduodenoscopy
• Interventions: Drug: Propofol Injection; Drug: Etomidate Injection

• Registration Number: NCT05407870
• Lead Sponsor: Korea University Anam Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-02
• Study First Posted: 2022-06-07
• Study Start: 2022-06-09
• Primary Completion: 2022-11-24
• Study Completion: 2022-11-24
• Status Verified: 2024-09
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol Injection	induction - 0.5mg/kg Propofol maintenance - 0.25mg/kg Propofol
Etomidate	Etomidate Injection	induction - 0.25mg/kg Propofol + 0.05mg/kg Etomidate maintenance - 0.05mg/kg Etomidate

Primary Outcome Measures

Name	Time	Method
Respiratory adverse event	during gastric endoscopic submucosal dissection	the number and proportion of cases of respiratory depression

Secondary Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Seoung-buk Gu, Korea, Republic of