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This study aimed to determine the median effective dose (ED50) of remimazolam for loss of consciousness (LOC) in elderly and frail elderly patients using the Dixon up-and-down method, while utilizing a novel Respiratory Volume Monitor (RVM) to detect subclinical respiratory depression.
The physiological decline associated with frailty in elderly patients presents significant challenges for anesthesia induction. Remimazolam tosilate, an ultra-short-acting benzodiazepine, offers a promising safety profile, yet its optimal dosing in frail populations remains undefined. This prospective, up-and-down sequential allocation trial was conducted at the Second Hospital of Hebei Medical University. 58 patients aged ≥65 years undergoing elective surgery were stratified into two groups: an Elderly Group (Clinical Frailty Scale [CFS] < 5) and a Frail Elderly Group (CFS ≥ 5). The initial remimazolam induction dose was set at 0.15 mg/kg for the elderly group and 0.13 mg/kg for the frail group, with dose adjustments based on the previous patient's response. A non-invasive RVM was employed to continuously monitor Tidal Volume (VT) and detect early hypoventilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderly Group (Non-Frail) | Experimental | Patients with a Clinical Frailty Scale (CFS) score < 5. |
|
| Frail Elderly Group | Experimental | Patients with a Clinical Frailty Scale (CFS) score ≥ 5. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam Tosilate | Drug | The initial induction dose was set at 0.15 mg/kg administered as a single intravenous bolus over 30 seconds. The dose adjustment gradient for consecutive patients was 0.02 mg/kg based on the Dixon up-and-down method. |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation Success (Loss of Consciousness) | Defined as the achievement of Loss of Consciousness (LOC) confirmed by loss of eyelash reflex, no response to verbal commands, Ramsay Sedation Score ≥ 5, and MOAA/S score < 1. | up to 2 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Median Effective Dose (ED50) of Remimazolam | The ED50 calculated via probit analysis based on the Dixon up-and-down sequential allocation method. | Perioperative/Periprocedural |
| Changes in Tidal Volume (VT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Remimazolam Tosilate | Drug | The initial induction dose was set at 0.13 mg/kg administered as a single intravenous bolus over 30 seconds. The dose adjustment gradient for consecutive patients was 0.01 mg/kg based on the Dixon up-and-down method. |
|
Continuous assessment of spontaneous Tidal Volume (VT) utilizing a non-invasive Respiratory Volume Monitor (RVM) to evaluate subclinical respiratory depression.
| Baseline, 30 seconds, 60 seconds, 90 seconds, and up to 120 seconds post-administration |
| Mean Arterial Pressure (MAP) | Changes in Mean Arterial Pressure (MAP) during the induction period, measured in mmHg. | Baseline and up to 2 minutes post-administration |
| Heart Rate (HR) | Changes in Heart Rate (HR) during the induction period, measured in beats per minute. | Baseline and up to 2 minutes post-administration |