Efficacy and Safety of Etomidate Sedation in Gastric Endoscopic Submucosal Dissection

Korea University

Status: Completed

Conditions: Esophagogastroduodenoscopy; Sedation Complication; Endoscopic Submucosal Dissection

Treatments: Drug: Propofol Injection; Drug: Etomidate Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05407870

2020AN0375

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 2 patient groups

Propofol

Active Comparator group

Description:

induction - 0.5mg/kg Propofol maintenance - 0.25mg/kg Propofol

Treatment:

Drug: Propofol Injection

Etomidate

Experimental group

Description:

induction - 0.25mg/kg Propofol + 0.05mg/kg Etomidate maintenance - 0.05mg/kg Etomidate

Treatment:

Drug: Etomidate Injection