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Clinical Trials/NCT05723627
NCT05723627
Completed
Not Applicable

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

Yonsei University1 site in 1 country70 target enrollmentApril 6, 2023

Overview

Phase
Not Applicable
Intervention
Remimazolam besylate
Conditions
Diagnostic Gastric Endoscopy
Sponsor
Yonsei University
Enrollment
70
Locations
1
Primary Endpoint
Incidence of Oxygen Reserve Index (ORI) drop to 0.00 during sedation
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 6, 2023
End Date
September 21, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Remimazolam

Patient group who receives remimazolam for sedation during endoscopy

Intervention: Remimazolam besylate

Propofol

Patient group who receives propofol for sedation during endoscopy

Intervention: Propofol

Outcomes

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.

Study Sites (1)

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