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

Prostate Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06093971
• Other study ID #: 4-2023-0803
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: September 2025

Study information

• Verified date: October 2023
• Source: Yonsei University
• Contact: So Yeon Kim
• Phone: 82-2-2228-2429
• Email: KIMSY326[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Tumor
• Prostatic Neoplasms

Intervention

Drug:
• remimazolam
Remimazolam is administered for anesthesia induction.
• Propofol
Propofol is administered for anesthesia induction.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypotension incidence (unit: event number)	mean arterial pressure (MAP)<65 mmHg for 5 min	during the total anesthesia duration
Primary	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
Primary	Vasopressor dose (unit: mcg for norepinephrine)	total dose of norepinephrine administered	during the total anesthesia duration
Primary	Vasopressor dose (unit for vasopressin)	total dose of vasopressin administered	during the total anesthesia duration