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NCT Number: NCT06093971

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

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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Key information

Conditions

Prostate Tumor Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University College of Medicine

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam

Drug

Remimazolam is administered for anesthesia induction.

Propofol

Drug

Propofol is administered for anesthesia induction.

Primary outcomes

  1. Hypotension occurrence (unit: number of patients)

    Time frame: during the total anesthesia duration

    "MAP<65mmHg for 1 min

  2. 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)

  3. Vasopressor dose (unit: mcg for norepinephrine)

    Time frame: during the total anesthesia duration

    total dose of norepinephrine administered

  4. Vasopressor dose (unit for vasopressin)

    Time frame: during the total anesthesia duration

    total dose of vasopressin administered

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2023
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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