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Completed

NCT Number: NCT07467603

ED50 of Remimazolam for Anesthesia Induction in Frail Elderly Patients

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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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥65 years;
  • Scheduled for elective surgery under general anesthesia with endotracheal intubation;
  • American Society of Anesthesiologists (ASA) physical status II or III;
  • Body Mass Index (BMI) between 18 and 30 kg/m².

Exclusion criteria

  • Known allergy to benzodiazepines;
  • History of severe respiratory or cardiovascular disease (e.g., acute heart failure, severe COPD);
  • Long-term use of sedatives, analgesics, or alcohol abuse;
  • Known neuromuscular disorders (e.g., myasthenia gravis);
  • Inability to communicate for sedation assessment.

Treatment and study plan

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.

Primary outcomes

  1. Sedation Success (Loss of Consciousness)

    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.

Secondary outcomes

  1. Median Effective Dose (ED50) of Remimazolam

    Time frame: Perioperative/Periprocedural

    The ED50 calculated via probit analysis based on the Dixon up-and-down sequential allocation method.

  2. Changes in Tidal Volume (VT)

    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.

  3. Mean Arterial Pressure (MAP)

    Time frame: Baseline and up to 2 minutes post-administration

    Changes in Mean Arterial Pressure (MAP) during the induction period, measured in mmHg.

  4. Heart Rate (HR)

    Time frame: Baseline and up to 2 minutes post-administration

    Changes in Heart Rate (HR) during the induction period, measured in beats per minute.

Sponsors and collaborators

Lead sponsor

The First Hospital of Hebei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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