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Sedation outcomes of remimazolam vs propofol

Comparison of respiratory depression of remimazolam vs propofol for sedation in painful procedure

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0009046
Enrollment
60
Registered
2023-12-14
Start date
2026-04-08
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The study will be divided into a Remimazolam group and a Propofol group. Both groups will be premedicated with fentanyl (1 µg/kg) for pain control. Both will be sedated with either remimazolam

Sponsors

The Catholic University of Korea, Seoul St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for prostate biopsy 2. Adults (19 years of age or older) 3. American Society of Anesthesiologists class 1 or 2

Exclusion criteria

Exclusion criteria: 1. Patient has not consented to participate in this study 2. Patients who need to be cautious with the administration of Remimazolam or Propofol 2-1. severe hepatic impairment 2-2. severe renal impairment 2-3. patients with serious respiratory and cardiovascular diseases 3. Pediatric (less than 19 years of age) 4. American Society of Anesthesiologists class 3 or higher 5. Bleeding requiring intraoperative use of colloid agents or blood transfusions, or hemodynamic instability such that intraoperative use of inotropic agents is required.

Design outcomes

Primary

MeasureTime frame
Oxygen reserve index value

Secondary

MeasureTime frame
Frequency of hypoxemia (SaO2<90), hypotension (SBP <90 mmHg) during the procedure and treatment for them, and frequency of procedural interventions during the procedure.;Frequency of hypoxemia (SaO2<90), hypotension (SBP <90 mmHg) during the procedure and treatment for them, and frequency of procedural interventions during the procedure.

Countries

Korea, Republic of

Contacts

Public ContactJaesik Park

The Catholic University of Korea, Seoul St. Mary's Hospital

jaesik.park@gmail.com+82-2-2258-6150

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Apr 17, 2026