MedDataX Logo

Comparison of Remimazolam and Propofol Effect on Oxygenation Reservoir During Diagnostic Gastric Endoscopy

NCT ID: NCT05723627

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-06

Study Completion Date

2023-09-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Propofol is one of the most commonly used sedative in endoscopic procedures, while its potency to induce respiratory depression may threaten patient safety. Remimazolam is known to less likely induce hemodynamic instability when compared to propofol, yet its favorable effects are not clearly evaluated in endoscopic procedures. Hence, this study aimed to compare hemodynamic effects of remimazolam and propofol, by evaluating oxygen reserve index (ORI) in patients scheduled for diagnostic gastric endoscopy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diagnostic Gastric Endoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Remimazolam

Patient group who receives remimazolam for sedation during endoscopy

Group Type EXPERIMENTAL

Remimazolam besylate

Intervention Type DRUG

Patients in this group receives 0.1mg/kg of remimazolam to induce sedation prior to endoscope insertion.

Propofol

Patient group who receives propofol for sedation during endoscopy

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Patients in this group receives 0.5mg/kg of propofol to induce sedation prior to endoscope insertion.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Remimazolam besylate

Patients in this group receives 0.1mg/kg of remimazolam to induce sedation prior to endoscope insertion.

Intervention Type DRUG

Propofol

Patients in this group receives 0.5mg/kg of propofol to induce sedation prior to endoscope insertion.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients (age 19\~80 yrs, ASA Class I\~III, ECOG 0\~1) who are scheduled for elective diagnostic gastric endoscopy

Exclusion Criteria

Pregnancy Allergy to remimazolam or propofol Underlying pulmonary diseases or obstructive sleep apnea Hypotension (SBP \<80mmHg) or hypoxemia (SpO2 \<90%) assessed prior to procedure
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sung Kwan Shin

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Yonsei University College of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4-2022-1369

Identifier Type: -

Identifier Source: org_study_id