Efficacy and Safety of Etomidate Sedation in Gastric Endoscopic Submucosal Dissection

NCT05407870 | Completed

• 1 other identifier: 2020AN0375
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation Complication; Endoscopic Submucosal Dissection; Esophagogastroduodenoscopy

Keywords

Etomidate; Propofol

Outcome Measures

Primary Outcomes (1)

• Respiratory adverse event

  the number and proportion of cases of respiratory depression

  during gastric endoscopic submucosal dissection

Secondary Outcomes (6)

• ESD clinical outcomes

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

• Adverse events and procedure interruptions

  during gastric endoscopic submucosal dissection

• Sedation-related profile

  From initial administering the sedative drug to endoscopy room discharge (up to 2 hours); dose (ml)

• Satisfaction assessment

  From initial administering the sedative drug to endoscopy room discharge; satisfaction score (0-10, 10 is the highest score)

• Hemodynamic changes

  From date of randomization until the date of first documented progression (up to 2 hours)

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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

Drug: Propofol Injection

Etomidate

EXPERIMENTAL

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

Drug: Etomidate Injection

Interventions

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.

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.

Propofol

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19-80
• American Society of Anesthesiologists Physical Status Classification System (ASA) score of I, II, III
• Scheduled endoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, Seoung-buk Gu, 02841, South Korea

Location

MeSH Terms

Interventions

Etomidate; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 7, 2022
• Study Start: June 9, 2022
• Primary Completion: November 24, 2022
• Study Completion: November 24, 2022
• Last Updated: November 12, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)