Effect of Remimazolam on Hypoxemia and/or Hypotension in Prostate Biopsy

NCT07854197 | Not Yet Recruiting

• 1 other identifier: IIT-2026-0002
• Study Type: interventional
• Target: 1,146
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  During the sedation period of the prostate biopsy procedure

Secondary Outcomes (12)

• The incidence of hypoxia during the sedation process.

  During the sedation period of the prostate biopsy procedure

• The incidence of severe hypoxia during the sedation process.

  During the sedation period of the prostate biopsy procedure

• The incidence of subclinical respiratory depression during the sedation process.

  During the sedation period of the prostate biopsy procedure

• The incidence of hypotension during the sedation period .

  During the sedation period for prostate biopsy surgery

• Success rate of sedation

  During the sedation period of the prostate biopsy procedure

Study Arms (2)

Remimazolam group

EXPERIMENTAL

Administer 0.2mg/kg of remimazolam for sedation

Drug: Using remimazolam for sedation during prostate biopsy

Propofol group

ACTIVE COMPARATOR

Administer 1.5mg/kg of propofol for sedation

Drug: Administer 1.5mg/kg of propofol for sedation

Interventions

Using remimazolam for sedation during prostate biopsy DRUG

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.

Remimazolam group

Administer 1.5mg/kg of propofol for sedation DRUG

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.

Propofol group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years old ≤ age ≤ 80 years old;
• undergo sedated transperineal prostate biopsy;
• kg/m2 ≤ BMI\<30kg/m2
• ASA ≤ III;
• voluntarily participate in the research and sign the informed consent form.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 8, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share