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Completed

NCT Number: NCT05407870

Efficacy and Safety of Etomidate Sedation in Gastric Endoscopic Submucosal Dissection

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.

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Key information

Conditions

Sedation Complication Endoscopic Submucosal Dissection Esophagogastroduodenoscopy

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Anam Hospital

Seoul, Seoung-buk Gu, 02841, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etomidate Injection

Drug

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

Drug

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.

Primary outcomes

  1. Respiratory adverse event

    Time frame: during gastric endoscopic submucosal dissection

    the number and proportion of cases of respiratory depression

Secondary outcomes

  1. ESD clinical outcomes

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

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

  2. Adverse events and procedure interruptions

    Time frame: 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

  3. Sedation-related profile

    Time frame: 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

  4. Satisfaction assessment

    Time frame: 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

  5. Hemodynamic changes

    Time frame: 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

  6. Factors associated with adverse events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 7, 2022
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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