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The investigators conduct a random assignment into either the remimazolam group or the propofol group. Depending on the group assignment, either remimazolam (0.2 mg/kg) or propofol (1.0 mg/kg) is administered. If necessary, additional doses of remimazolam (0.1 mg/kg) or propofol (0.5 mg/kg) are given. The standard anesthesia procedure of our institution is followed, and blood pressure data recorded during the surgery is analyzed (mean arterial pressure <65mmHg is defined as hypotension).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group remimazolam | Experimental | During anesthesia induction, the remimazolam group (group R) receives remimazolam (0.2 mg/kg). If necessary, an additional dose of remimazolam (0.1 mg/kg) is administered. |
|
| Group propofol | Active Comparator | During anesthesia induction, the propofol group (group P) receives propofol (1.0 mg/kg). If necessary, an additional dose of propofol (0.5 mg/kg) is administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remimazolam | Drug | Remimazolam is administered for anesthesia induction. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hypotension occurrence (unit: number of patients) | "MAP<65mmHg for 1 min | during the total anesthesia duration |
| Amount of hypotension (unit: mmHg) | time-weighted average MAP <65mmHg => depth of hypotension (mmHg) below a MAP of 65 mmHg * time (min) below a MAP of 65 mmHg)/ total duration of surgery (min) | during the total anesthesia duration |
| Vasopressor dose (unit: mcg for norepinephrine) | total dose of norepinephrine administered | during the total anesthesia duration |
| Vasopressor dose (unit for vasopressin) | total dose of vasopressin administered | during the total anesthesia duration |
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Inclusion Criteria:
Patients who undergo robot-assisted laparoscopic prostatectomy and who have taken renin-angiotensin system blockers for more than 3 months.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| So Yeon Kim | Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University College of Medicine | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41942542 | Derived | Yang ZJ, Wu Y, Zhao XY, Qi XS. Ultrasound-guided lung recruitment maneuver in pediatric acute respiratory distress syndrome. Sci Rep. 2026 Apr 6;16(1):16496. doi: 10.1038/s41598-026-43537-1. | |
| 41233396 | Derived | Kim HJ, Kim N, Kim J, Park JH, Shin HJ, Yang J, Kim SY. Intraoperative hypotension after remimazolam or propofol induction with sevoflurane maintenance in angiotensin II receptor blockers-treated patients: a randomized controlled trial. Sci Rep. 2025 Nov 13;15(1):39805. doi: 10.1038/s41598-025-23469-y. |
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| Propofol |
| Drug |
Propofol is administered for anesthesia induction. |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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