FrailtyNCT07467603
ED50 of Remimazolam for Anesthesia Induction in Frail Elderly Patients
A study testing Remimazolam Tosilate in people with Frailty and Anesthesia Induction, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Anesthesia Induction
- What is being tested?
- Remimazolam Tosilate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Frailty, Anesthesia Induction
- Being tested
- Remimazolam Tosilate
- Keywords
- Remimazolam Tosilate, Frailty, Anesthesia Induction, Median Effective Dose (ED50), Dixon Up-and-Down Method, Respiratory Volume Monitor (RVM)
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam TosilateDrug
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.
Remimazolam TosilateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Elderly Group (Non-Frail) | Experimental | Patients with a Clinical Frailty Scale (CFS) score < 5. Receives: Drug: Remimazolam Tosilate |
| Frail Elderly Group | Experimental | Patients with a Clinical Frailty Scale (CFS) score ≥ 5. Receives: Drug: Remimazolam Tosilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 minutes
Secondary outcomes (4)
Median Effective Dose (ED50) of Remimazolam
The ED50 calculated via probit analysis based on the Dixon up-and-down sequential allocation method.
Measured: Perioperative/Periprocedural
Changes in Tidal Volume (VT)
Continuous assessment of spontaneous Tidal Volume (VT) utilizing a non-invasive Respiratory Volume Monitor (RVM) to evaluate subclinical respiratory depression.
Measured: 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.
Measured: 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.
Measured: Baseline and up to 2 minutes post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Feb 2025
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanjie Yang, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467603
- Sponsor's protocol ID
- 2025-R031
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07467603
- Acronym / sponsor ID
- 2025-R031
- Conditions
- Frailty, Anesthesia Induction
- Keywords
- Remimazolam Tosilate, Frailty, Anesthesia Induction, Median Effective Dose (ED50), Dixon Up-and-Down Method, Respiratory Volume Monitor (RVM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly Group (Non-Frail) | Experimental | Drug: Remimazolam TosilatePatients with a Clinical Frailty Scale (CFS) score < 5. |
| Frail Elderly Group | Experimental | Drug: Remimazolam TosilatePatients with a Clinical Frailty Scale (CFS) score ≥ 5. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remimazolam TosilateThe 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. | Drug | Elderly Group (Non-Frail) |
| Remimazolam TosilateThe 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. | Drug | Frail Elderly Group |
Primary outcome
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.
4 secondary outcomes
Median Effective Dose (ED50) of Remimazolam
Time frame: Perioperative/Periprocedural
Changes in Tidal Volume (VT)
Time frame: Baseline, 30 seconds, 60 seconds, 90 seconds, and up to 120 seconds post-administration
Mean Arterial Pressure (MAP)
Time frame: Baseline and up to 2 minutes post-administration
Heart Rate (HR)
Time frame: Baseline and up to 2 minutes post-administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam Tosilate in people with Frailty and Anesthesia Induction, run by The First Hospital of Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedation Success (Loss of Consciousness) (time frame: up to 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.