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

Sponsor

Yonsei University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05723627

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diagnostic Gastric Endoscopy	Drug: Remimazolam besylate Drug: Propofol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remimazolam Patient group who receives remimazolam for sedation during endoscopy	Drug: Remimazolam besylate Patients in this group receives 0.1mg/kg of remimazolam to induce sedation prior to endoscope insertion.
Active Comparator: Propofol Patient group who receives propofol for sedation during endoscopy	Drug: Propofol Patients in this group receives 0.5mg/kg of propofol to induce sedation prior to endoscope insertion.

Arm

Intervention/Treatment

Experimental: Remimazolam

Patient group who receives remimazolam for sedation during endoscopy

Drug: Remimazolam besylate

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

Active Comparator: Propofol

Patient group who receives propofol for sedation during endoscopy

Drug: Propofol

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University Health System, Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

Principal Investigator: Sung Kwan Shin, Department of Internal Medicine, Yonsei University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT05723627

Other Study ID Numbers:

4-2022-1369

First Posted:

Feb 13, 2023

Last Update Posted:

Feb 13, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Propofol

Study Results

No Results Posted as of Feb 13, 2023