Efficacy and Safety of Etomidate Sedation in Gastric Endoscopic Submucosal Dissection

October 19, 2022 updated by: Chun, Hoon Jai, Korea University Anam Hospital

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Propofol
induction - 0.5mg/kg Propofol maintenance - 0.25mg/kg Propofol
Drug: 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.
Experimental: Etomidate
induction - 0.25mg/kg Propofol + 0.05mg/kg Etomidate maintenance - 0.05mg/kg Etomidate
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Anam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2022

Primary Completion (Anticipated)

November 10, 2022

Study Completion (Anticipated)

November 30, 2022

Study Registration Dates

First Submitted

June 2, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Actual)

October 21, 2022

Last Update Submitted That Met QC Criteria

October 19, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020AN0375

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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