Remimazolam Versus Propofol for General Anesthesia Induction in Patients on Renin-angiotensin System Blockers Undergoing Robot-assisted Laparoscopic Prostatectomy

Study Overview
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Brief Summary
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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).

Official Title
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Remimazolam Versus Propofol for General Anesthesia Induction in Patients on Renin-angiotensin System Blockers Undergoing Robot-assisted Laparoscopic Prostatectomy: A Randomized Controlled Study

Conditions
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Prostate Tumor

Intervention / Treatment
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* Drug: remimazolam
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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: emergency surgery If the subject includes those who cannot read the consent form (e.g. illiterate, foreigners, etc.) cognitive dysfunction Atrial fibrillation, moderate to severe valvular disease, ejection fraction of 35% or less Patients who did not take renin-angiotensin system blockers on the day of surgery

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group remimazolam<br>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. | Drug: remimazolam<br>* Remimazolam is administered for anesthesia induction.<br>|
| Active Comparator: Group propofol<br>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. | Drug: Propofol<br>* Propofol is administered for anesthesia induction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension incidence (unit: event number) | mean arterial pressure (MAP)<65 mmHg for 5 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 |