Effect of Remimazolam on Hypoxemia and/or Hypotension in Prostate Biopsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age65-80
SponsorRenJi Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
65 years old ≤ age ≤ 80 years old;
undergo sedated transperineal prostate biopsy;
18.5kg/m2 ≤ BMI<30kg/m2
ASA ≤ III;
Disqualifiers
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.);
Trial design
Design model
Parallel
Treatments tested in this trial
Using remimazolam for sedation during prostate biopsy
DrugAdminister 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 sedation
DrugAdminister 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.
Treatment groups
1,146 Participants
are divided into 2 treatment groupsGroup A: Remimazolam groupExperimental treatment 1 intervention
Group B: Propofol groupActive comparator 1 intervention
Trial outcomes
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.
Time frame
During the sedation period of the prostate biopsy procedureSecondary outcomes
1
The incidence of hypoxia during the sedation process.
SpO2 \< 90%
Time frame
During the sedation period of the prostate biopsy procedure2
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%
Time frame
During the sedation period of the prostate biopsy procedure3
The incidence of subclinical respiratory depression during the sedation process.
90% ≤ SpO2 \< 95%
Time frame
During the sedation period of the prostate biopsy procedure4
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.
Time frame
During the sedation period for prostate biopsy surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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