Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
NCT Number: NCT07467603
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.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Shijiazhuang, Hebei, 050000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: up to 2 minutes
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.
Time frame: Perioperative/Periprocedural
The ED50 calculated via probit analysis based on the Dixon up-and-down sequential allocation method.
Time frame: Baseline, 30 seconds, 60 seconds, 90 seconds, and up to 120 seconds post-administration
Continuous assessment of spontaneous Tidal Volume (VT) utilizing a non-invasive Respiratory Volume Monitor (RVM) to evaluate subclinical respiratory depression.
Time frame: Baseline and up to 2 minutes post-administration
Changes in Mean Arterial Pressure (MAP) during the induction period, measured in mmHg.
Time frame: Baseline and up to 2 minutes post-administration
Changes in Heart Rate (HR) during the induction period, measured in beats per minute.
The First Hospital of Hebei Medical University
Other
Significantly Reduced Median Effective Dose (ED50) of Remimazolam for Anesthesia Induction in Frail Elderly Patients: A Prospective Dose-Finding Clinical Trial With Respiratory Volume Monitoring
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