Prostate BiopsyNCT07854197
Effect of Remimazolam on Hypoxemia and/or Hypotension in Prostate Biopsy
A study testing Using remimazolam for sedation during prostate biopsy and Administer 1.5mg/kg of propofol for sedation in people with Prostate Biopsy and Sedation Complication, run by RenJi Hospital.
Trial summary
This study aims to investigate whether remimazolam, a novel benzodiazepine sedative, can reduce the composite incidence of hypotension and hypoxemia during prostate biopsy in elderly patients compared with propofol. Read more about this study
- Who is it for?
- Ages 65 to 80 years, men only
- Conditions the study is for
- Prostate Biopsy, Sedation Complication
- What is being tested?
- Using remimazolam for sedation during prostate biopsy and Administer 1.5mg/kg of propofol for sedation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,146 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2026to 1 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years old ≤ age ≤ 80 years old;
- undergo sedated transperineal prostate biopsy;
- 18.5kg/m2 ≤ BMI<30kg/m2
- ASA ≤ III;
- voluntarily participate in the research and sign the informed consent form.
Who cannot join
- expected difficult airway;
- hypertension (with a systolic blood pressure of ≥ 180 mmHg and/or a diastolic blood pressure of ≥ 100 mmHg), or with a systolic blood pressure of ≤ 90 mmHg;
- baseline SpO2 < 93%, or RR < 10 b/m or more than 24 b/m, or a clear diagnosis of obstructive sleep apnea syndrome (OSAS);
- diagnosed with heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.);
- diagnosed with lung diseases (asthma, bronchitis, COPD, pulmonary bullae, pulmonary embolism, pulmonary oedema, etc.);
- hepatic dysfunction (aspartate aminotransferase and/or alanine aminotransferase ≥ 2.5 times the upper limit of normal value, total bilirubin ≥ 1.5 times the upper limit of normal value);
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- renal insufficiency (creatinine level ≥ 1.5 times the upper limit of the normal range);
- cognitive or mental disorders;
- history of drug and/or alcohol abuse within 2 years before initiating the screening period; average daily alcohol consumption of >2 units of alcohol (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol content or 150 mL grapes liquor);
- allergies or contraindication to benzodiazepines, opioids, propofol;
- use of benzodiazepines, propofol and opioid drugs within the past three months;
- participated in other drug clinical trials in the past 3 months;
- investigator's judgment as an unsuitable participant.
About this study
Official title: Effect of Remimazolam Sedation on Composite Adverse Events in Elderly Patients Undergoing Prostate Biopsy: A Prospective Multicenter Randomized Controlled Trial
This study aims to investigate whether remimazolam, a novel benzodiazepine sedative, can reduce the composite incidence of hypotension and hypoxemia during prostate biopsy in elderly patients compared with propofol. This study is a multicenter prospective randomized controlled trial.Participants will be recruited from five centers: Renji Hospital (Shanghai), Sun Yat-sen University Cancer Center, Zhongda Hospital (Nanjing), Shenzhen Hospital of the Cancer Hospital (CAMS), and Liaoning Fangda General Hospital.Baseline data will be collected for all participants, including demographic information, comorbidities, concurrent medication use, and vital signs.A total of 1,146 eligible participants will be randomized in a 1:1 ratio to receive either remimazolam (experimental group) or propofol (control group). Intraoperative hypoxemia and hypotension will be recorded as the primary outcomes. Secondary outcomes will include other sedation-related adverse events and patient satisfaction, which will be evaluated to comprehensively assess the efficacy and safety profile of remimazolam.
- Conditions
- Prostate Biopsy, Sedation Complication
- Being tested
- Using remimazolam for sedation during prostate biopsy, Administer 1.5mg/kg of propofol for sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using remimazolam for sedation during prostate biopsyDrug
Administer 0.2mg/kg remimazolam, with the infusion time exceeding 10 seconds. Once the subject reaches a sufficient level of sedation (MOAA/S score ≤ 1), the operating doctor performs local infiltration anesthesia at the perineal puncture site with 5-10ml of 2% lidocaine, and then begins the prostate puncture procedure.
Administer 1.5mg/kg of propofol for sedationDrug
Administer 1.5mg/kg of propofol, with the injection time exceeding 10 seconds. Once the subject reaches a sufficient level of sedation (MOAA/S score ≤ 1), the operating doctor performs local infiltration anesthesia at the perineal puncture site with 2% lidocaine, and then begins the prostate puncture procedure.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam group | Experimental | Administer 0.2mg/kg of remimazolam for sedation Receives: Drug: Using remimazolam for sedation during prostate biopsy |
| Propofol group | Active comparator | Administer 1.5mg/kg of propofol for sedation Receives: Drug: Administer 1.5mg/kg of propofol for sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of composite adverse events during sedation
Composite adverse events are defined as the occurrence of hypoxemia and/or hypotension. Hypoxemia is defined as SpO₂ < 90%, and hypotension is defined as a mean arterial pressure (MAP) ≤ 70 mmHg or a decrease of more than 30% from baseline.
Measured: During the sedation period of the prostate biopsy procedure
Secondary outcomes (12)
The incidence of hypoxia during the sedation process.
SpO2 < 90%
Measured: During the sedation period of the prostate biopsy procedure
The incidence of severe hypoxia during the sedation process.
SPO2 is between 75% and 90% for a duration of ≥ 60 seconds, or SPO2 is less than 75%
Measured: During the sedation period of the prostate biopsy procedure
The incidence of subclinical respiratory depression during the sedation process.
90% ≤ SpO2 < 95%
Measured: During the sedation period of the prostate biopsy procedure
The incidence of hypotension during the sedation period .
Hypotension is defined as a mean arterial pressure (MAP) ≤ 70 mmHg or a decrease of more than 30% from baseline.
Measured: During the sedation period for prostate biopsy surgery
Success rate of sedation
Measured: During the sedation period of the prostate biopsy procedure
Induction Time
The time from the first administration of sedatives (remiamorol or propofol) to when the MOAA/S score reaches ≤1 indicating a sedated state
Measured: During the sedation period of the prostate biopsy procedure
Awakening time
The time from the cessation of drug administration to when the MOAA/S score remained at 5 for three consecutive times
Measured: During the recovery period of the prostate biopsy procedure
The incidence rate of injection pain
Measured: During the sedation period of the prostate biopsy procedure
The incidence of patient movement during the procedure.
Measured: During the sedation period of the prostate biopsy procedure
Operator satisfaction with the conduct of the prostate biopsy procedure
After the prostate puncture procedure, ask about the satisfaction level with the operating doctor. Assess using a Numerical Rating Scale ranging from 0 to 10, where 1 to 3 means "dissatisfied," 4 to 6 means "satisfied," and 7 to 10 means "very satisfied."
Measured: During the whole prostate biopsy procedure
Patient satisfaction
Before the patient leaves the recovery room after fully waking up, ask about the patient's satisfaction level. Assess using a Numerical Rating Scale ranging from 0 to 10, where 1 to 3 means "dissatisfied," 4 to 6 means "satisfied," and 7 to 10 means "very satisfied."
Measured: During the whole prostate biopsy procedure
Visual Analogue Scale (VAS) score 15 minutes after prostate biopsy
Perform a pain assessment using a Visual Analogue Scale (VAS) 15 minutes after the surgery, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain the patient has ever experienced.
Measured: 15 minutes after prostate biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start8 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Tian, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854197
- Sponsor's protocol ID
- IIT-2026-0002
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No