Sedation and analgesia for elderly patients undergoing prostate biopsy

Comparison of Remimazolam versus Propofol for Elderly Patients during Prostate Biopsy: Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031240478

Enrollment

Registered

2024-11-11

Start date

2024-11-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer Prostate cancer

Interventions

Remimazolam group Fentanyl 2 microg/kg (0.04 mL/kg) is administered (Fentanyl was adjusted to achieve an effective site concentration of around 2 microg/ml in Shafer's model. 0.5 microg/kg (0.01 mL/k

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - 70 years old and older - Male - patients undergoing prostate biopsy - patients under intravenous anethesia with sedatives and analgesics

Exclusion criteria

Exclusion criteria: Patients on antiplatelet or anticoagulant medications Obesity patients with a Body Mass Index of 35 or higher Patients with a diagnosis of sleep apnea syndrome Patients who cannot move their neck after neck radiation therapy or due to cervical spondylosis Patients with chronic obstructive pulmonary disease Patients with impaired consciousness Patients with anatomically poor mask fitting Patients with anatomically inability to insert nasopharyngeal airway Patients taking benzodiazepines Patients allergic to propofol, remimazolam, or fentanyl Patients with contraindications to fentanyl (contraindications to muscle relaxants, susceptibility to respiratory depression, e.g. coma due to head injury or brain tumor, history of seizures, asthma, receiving or discontinuing nalmefene hydrochloride hydrate within 1 week) Patients with contraindications to remimazolam (acute angle-closure glaucoma, myasthenia gravis, shock, coma, acute alcohol intoxication with suppressed vital signs)

Design outcomes

Primary

Measure	Time frame
Presence of Apnea (more than 1 minute)	—

Secondary

Measure	Time frame
Frequency and duration of hypoxemia (SpO2 < 90%), frequency and duration of respiratory depression (respiratory rate < 8 breaths/min), Presence of mask ventilation, Presence of intubation	—

Contacts

Public ContactKentaro Fukano

Jichi Medical University Saitama Medical Center

kentar7@jichi.ac.jp+81-48-647-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026