Completed

NCT Number: NCT05723627

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diagnostic Gastric Endoscopy

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Remimazolam besylate

Drug

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

Propofol

Drug

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

Primary outcomes

Incidence of Oxygen Reserve Index (ORI) drop to 0.00 during sedation

Time frame: Evaluation begins after sedative administration until the end of endoscopic procedure.

Incidence of Oxygen Reserve Index (ORI) drop to 0.00 will be evaluated after sedative administration, until the end of endoscopic procedure.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Feb 13, 2023
Registry last updated: Dec 8, 2023

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.