Efficacy and Safety of Etomidate Sedation in Gastric Endoscopic Submucosal Dissection

NCT ID: NCT05407870

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-09
• Study Completion Date: 2022-11-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Propofol

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

Group Type: ACTIVE_COMPARATOR

Propofol Injection

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Etomidate Injection

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea University Anam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Keum, Bo Ra

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Korea University Anam Hospital

Seoul, Seoung-buk Gu, South Korea

Countries

South Korea

Other Identifiers

2020AN0375

Identifier Type: -

Identifier Source: org_study_id