Diagnostic Gastric Endoscopy
Conditions
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.
Interventions
DRUGRemimazolam besylate
Patients in this group receives 0.1mg/kg of remimazolam to induce sedation prior to endoscope insertion.
DRUGPropofol
Patients in this group receives 0.5mg/kg of propofol to induce sedation prior to endoscope insertion.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Oxygen Reserve Index (ORI) drop to 0.00 during sedation | 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. |
Countries
South Korea
Outcome results
None listed