Efficacy and Safety of Etomidate Sedation in Gastric Endoscopic Submucosal Dissection

Sedation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05407870
• Other study ID #: 2020AN0375
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: October 2022
• Source: Korea University Anam Hospital
• Contact: Han Jo Jeon, Ph.D
• Phone: +82-2-920-6555
• Email: roadstar82[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: November 30, 2022
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Endoscopic Submucosal Dissection
• Esophagogastroduodenoscopy
• Sedation Complication

Intervention

Drug:
• Etomidate Injection
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 Injection
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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul	Seoung-buk Gu

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	respiratory depressive event	the number and proportion of cases of respiratory depression	during gastric endoscopic submucosal dissection
Primary	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