Prostate Tumor
Conditions
Brief summary
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).
Interventions
DRUGremimazolam
Remimazolam is administered for anesthesia induction.
DRUGPropofol
Propofol is administered for anesthesia induction.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who undergo robot-assisted laparoscopic prostatectomy and who have taken renin-angiotensin system blockers for more than 3 months.
Exclusion criteria
1. emergency surgery 2. If the subject includes those who cannot read the consent form (e.g. illiterate, foreigners, etc.) 3. cognitive dysfunction 4. Atrial fibrillation, moderate to severe valvular disease, ejection fraction of 35% or less 5. Patients who did not take renin-angiotensin system blockers on the day of surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypotension occurrence (unit: number of patients) | during the total anesthesia duration | MAP\<65mmHg for 1 min |
| Amount of hypotension (unit: mmHg) | during the total anesthesia duration | 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) |
| Vasopressor dose (unit: mcg for norepinephrine) | during the total anesthesia duration | total dose of norepinephrine administered |
| Vasopressor dose (unit for vasopressin) | during the total anesthesia duration | total dose of vasopressin administered |
Countries
South Korea
Outcome results
None listed