Sedation and analgesia for elderly patients undergoing prostate biopsy

JRCT ID: jRCTs031240478

Registered date:11/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 18/11/2024
• Target sample size: 64
• Study type: Interventional

Intervention(s)

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/kg) is administered as needed once the concentration fell below 1.8 microg/mL). 2 minutes after the first dose of fentanyl, remimazolam 0.1 mg/kg is administered and continuous IV infusion is started at 1 mg/kg/hr. If MOAA/S 0 is not reached, first confirm that the effective site concentration of fentanyl is acceptable, and then increase the continuous dose of remimazolam by 0.1 mg/kg/hr after 0.05 mg/kg IV. If MOAA/S 0 and apnea time longer than 1 minute, decrease the dose of remimazolam by 0.1 mg/kg/hr.

Propofol 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/kg) is given as needed when the concentration fell below 1.8 microg/mL). 2 minutes after the first dose of fentanyl, propofol 0.5 mg/kg is administered and continuous IV infusion is started at 2 mg/kg/hr. If MOAA/S 0 is not reached, first confirm that the effective site concentration of fentanyl is acceptable, then administer propofol 0.25 mg/kg IV, then increase the continuous dose by 0.5 mg/kg/hr. If MOAA/S 0 and apnea time longer than 1 minute, decrease the propofol dose by 0.5 mg/kg/hr

Outcome(s)

• Primary Outcome: Presence of Apnea (more than 1 minute)
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 70age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

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

Exclude 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)

Related Information

• Primary Sponsor: Fukano Kentaro
• Secondary Sponsor: Iizuka Yusuke,Sanui Masamitsu