Remimazolam Versus Propofol for General Anesthesia Induction in Patients on Renin-angiotensin System Blockers Undergoing Robot-assisted Laparoscopic Prostatectomy: A Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- remimazolam
- Conditions
- Prostate Tumor
- Sponsor
- Yonsei University
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Hypotension occurrence (unit: number of patients)
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
Group remimazolam
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.
Intervention: remimazolam
Group propofol
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.
Intervention: Propofol
Outcomes
Primary Outcomes
Hypotension occurrence (unit: number of patients)
Time Frame: during the total anesthesia duration
"MAP\<65mmHg for 1 min
Vasopressor dose (unit: mcg for norepinephrine)
Time Frame: during the total anesthesia duration
total dose of norepinephrine administered
Amount of hypotension (unit: mmHg)
Time Frame: 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 for vasopressin)
Time Frame: during the total anesthesia duration
total dose of vasopressin administered