General AnesthesiaNCT07746505
Remimazolam Versus Midazolam for General Anesthesia Induction in Elderly Patients Undergoing Non-Cardiac Surgery
An observational study of General Anesthesia and Aged, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This prospective observational cohort study evaluates the effectiveness and safety of two benzodiazepine sedatives-remimazolam and midazolam-used for general anesthesia induction in elderly patients (≥65 years) undergoing elective non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- General Anesthesia, Aged, Intraoperative Hypotension
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2026to 15 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Elderly patients (≥65 years) scheduled for elective non-cardiac surgery under general anesthesia at a single tertiary center, who receive a benzodiazepine sedative (remimazolam or midazolam) for induction as part of routine clinical care.
Who may be able to join
- Age 65 years or older.
- Scheduled for elective non-cardiac surgery under general anesthesia.
- American Society of Anesthesiologists physical status I to IV.
- Planned airway management with tracheal intubation or a laryngeal mask airway.
- Written informed consent provided by the participant or the participant's legally authorized representative.
- -
Who cannot join
- Long-term preoperative benzodiazepine use.
- Known allergy or contraindication to benzodiazepines, flumazenil, opioids, naloxone, or related drugs.
- History of drug abuse or alcoholism within the past 2 years.
- No preoperative cognitive assessment available.
- Preoperative cognitive impairment, defined as a Mini-Mental State 6.Examination score less than 18.
- 7.Refusal to provide informed consent.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicin
Hangzhou
min Yan, doctor, +86 13757118632, zryanmin@zju.edu.cn
About this study
Official title: Effectiveness and Safety of Remimazolam Compared With Midazolam for General Anesthesia Induction in Elderly Patients Undergoing Non-Cardiac Surgery: A Prospective Observational Cohort Study
This prospective observational cohort study evaluates the effectiveness and safety of two benzodiazepine sedatives-remimazolam and midazolam-used for general anesthesia induction in elderly patients (≥65 years) undergoing elective non-cardiac surgery. Elderly patients have reduced organ reserve and altered pharmacokinetics/pharmacodynamics, increasing their susceptibility to anesthesia-related complications such as intraoperative hypotension, delayed emergence, and postoperative delirium. Remimazolam, an ultra-short-acting benzodiazepine metabolized by organ-independent tissue esterases, is hypothesized to offer greater hemodynamic stability, faster recovery, and a more favorable safety profile than midazolam in this vulnerable population. Investigators prospectively observe and collect data without altering routine clinical care; the choice of sedative is made by the attending anesthesiologist according to standard practice. Propensity score methods will be used to reduce confounding by indication.
Read the detailed description
This is a prospective, observational, cohort study. The exposure is the benzodiazepine sedative actually used at induction; patients are grouped as the remimazolam (RM) or midazolam (MZ) cohort based on the clinical record. Induction and maintenance are individualized by the attending anesthesiologist ; investigators only observe and collect data without altering routine care. All patients receive standard monitoring (ECG, SpO₂, non-invasive/invasive blood pressure, end-tidal CO₂, anesthetic depth). Collected data include demographics, medical history and risk factors, medication history, examination and laboratory results, and intraoperative variables (ASA class, surgery type and duration, hypotension, anesthetic and opioid doses, fluid balance, blood loss, transfusion).
- Conditions
- General Anesthesia, Aged, Intraoperative Hypotension, Anxiety
- Keywords
- Remimazolam, Midazolam, Elderly, Non-cardiac surgery, Anesthesia induction, Hemodynamic stability, Quality of recovery
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Remimazolam group (RM) | Elderly patients who receive remimazolam as the benzodiazepine sedative during general anesthesia induction (final dose and sequence determined individually by the attending anesthesiologist). | |
| Cohort 2: Midazolam group (MZ) | Elderly patients who receive midazolam as the benzodiazepine sedative during general anesthesia induction (final dose and sequence determined individually by the attending anesthesiologist). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Hypotension Burden Measured by the Time-Weighted Average of Mean Arterial Pressure (TWA-MAP) Below an Absolute Threshold (<65 mmHg) or a Relative Threshold (>20% Decrease From Baseline)
Intraoperative hypotension burden was quantified from mean arterial pressure (MAP) recordings obtained from anesthetic induction through the end of surgery (induction and maintenance periods).
Measured: From anesthetic induction through the end of surgery (intraoperative period)
Secondary outcomes (7)
Vasoactive drug requirement
Measured: Induction period and entire perioperative period Cumulative dose and frequency of vasoactive agents
Time to Extubation
Time from discontinuation of anesthetics to removal of the endotracheal tube.
Measured: During anesthesia emergence
Quality of Recovery at 24 Hours Postoperatively as Assessed by the Quality of Recovery-15 (QoR-15) Questionnaire
Quality of postoperative recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, a 15-item patient-reported instrument covering physical comfort, physical independence, emotional state, psychological support, and pain. Each item is scored on an 11-point scale from 0 to 10. The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
Measured: 24 hours after surgery
Perioperative Anxiety Assessed by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Perioperative anxiety was assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The HADS-A consists of 7 items, each rated from 0 to 3, yielding a total score ranging from 0 to 21. Higher scores indicate greater anxiety (a worse outcome).
Measured: Day of surgery and postoperative day 2
Composite of Major Organ Complications (Postoperative Delirium, Acute Kidney Injury, Stroke, Acute Myocardial Infarction, Pulmonary Infection, In-Hospital All-Cause Mortality, Postoperative Length of Stay, and Unplanned Reoperation)
postoperative delirium, acute kidney injury, stroke, acute myocardial infarction, or pulmonary infection. Postoperative delirium will be assessed using the Confusion Assessment Method or clinical documentation. Acute kidney injury will be defined according to Kidney Disease: Improving Global Outcomes criteria. Stroke and acute myocardial infarction will be diagnosed based on clinical, laboratory, electrocardiographic, imaging, and medical record evidence. Pulmonary infection will be diagnosed based on clinical symptoms, radiographic findings, laboratory results, and the need for antimicrobial treatment. In-hospital all-cause mortality will also be recorded.
Measured: From the end of surgery until hospital discharge, an average of 7 days
Incidence of Anesthesia-Related Adverse Events (Composite)
The number/proportion of participants experiencing one or more anesthesia-related adverse events during the perioperative period was recorded. Anesthesia-related adverse events included intraoperative awareness and postoperative nausea and vomiting (PONV).
Measured: perioperative
Length of Stay in the Post-Anesthesia Care Unit (PACU)
Length of stay in the post-anesthesia care unit (PACU), defined as the time from PACU admission until the patient meets PACU discharge readiness criteria, measured in minutes.
Measured: From PACU admission until PACU discharge readiness, assessed up to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start15 Jun 2026
- Primary completion16 Jun 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746505
- Sponsor's protocol ID
- 2026-0835
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Remimazolam Compared With Midazolam for General Anesthesia Induction in Elderly Patients Undergoing Non-Cardiac Surgery: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07746505
- Acronym / sponsor ID
- 2026-0835
- Conditions
- General Anesthesia, Aged, Intraoperative Hypotension, Anxiety
- Keywords
- Remimazolam, Midazolam, Elderly, Non-cardiac surgery, Anesthesia induction, Hemodynamic stability, Quality of recovery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 16 Jun 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 5 Aug 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 prospective observational cohort study evaluates the effectiveness and safety of two benzodiazepine sedatives-remimazolam and midazolam-used for general anesthesia induction in elderly patients (≥65 years) undergoing elective non-cardiac surgery. Elderly patients have reduced organ reserve and altered pharmacokinetics/pharmacodynamics, increasing their susceptibility to anesthesia-related complications such as intraoperative hypotension, delayed emergence, and postoperative delirium. Remimazolam, an ultra-short-acting benzodiazepine metabolized by organ-independent tissue esterases, is hypothesized to offer greater hemodynamic stability, faster recovery, and a more favorable safety profile than midazolam in this vulnerable population. Investigators prospectively observe and collect data without altering routine clinical care; the choice of sedative is made by the attending anesthesiologist according to standard practice. Propensity score methods will be used to reduce confounding by indication.
Detailed description
This is a prospective, observational, cohort study. The exposure is the benzodiazepine sedative actually used at induction; patients are grouped as the remimazolam (RM) or midazolam (MZ) cohort based on the clinical record. Induction and maintenance are individualized by the attending anesthesiologist ; investigators only observe and collect data without altering routine care. All patients receive standard monitoring (ECG, SpO₂, non-invasive/invasive blood pressure, end-tidal CO₂, anesthetic depth). Collected data include demographics, medical history and risk factors, medication history, examination and laboratory results, and intraoperative variables (ASA class, surgery type and duration, hypotension, anesthetic and opioid doses, fluid balance, blood loss, transfusion).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Remimazolam group (RM) | – | –Elderly patients who receive remimazolam as the benzodiazepine sedative during general anesthesia induction (final dose and sequence determined individually by the attending anesthesiologist). |
| Cohort 2: Midazolam group (MZ) | – | –Elderly patients who receive midazolam as the benzodiazepine sedative during general anesthesia induction (final dose and sequence determined individually by the attending anesthesiologist). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients (≥65 years) scheduled for elective non-cardiac surgery under general anesthesia at a single tertiary center, who receive a benzodiazepine sedative (remimazolam or midazolam) for induction as part of routine clinical care.
Key inclusion criteria (6 listed)
- Age 65 years or older.
- Scheduled for elective non-cardiac surgery under general anesthesia.
- American Society of Anesthesiologists physical status I to IV.
- Planned airway management with tracheal intubation or a laryngeal mask airway.
- Written informed consent provided by the participant or the participant's legally authorized representative.
Key exclusion criteria (7 listed)
- Long-term preoperative benzodiazepine use.
- Known allergy or contraindication to benzodiazepines, flumazenil, opioids, naloxone, or related drugs.
- History of drug abuse or alcoholism within the past 2 years.
- No preoperative cognitive assessment available.
- Preoperative cognitive impairment, defined as a Mini-Mental State 6.Examination score less than 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraoperative Hypotension Burden Measured by the Time-Weighted Average of Mean Arterial Pressure (TWA-MAP) Below an Absolute Threshold (<65 mmHg) or a Relative Threshold (>20% Decrease From Baseline)
Time frame: From anesthetic induction through the end of surgery (intraoperative period)
Intraoperative hypotension burden was quantified from mean arterial pressure (MAP) recordings obtained from anesthetic induction through the end of surgery (induction and maintenance periods).
7 secondary outcomes
Vasoactive drug requirement
Time frame: Induction period and entire perioperative period Cumulative dose and frequency of vasoactive agents
Time to Extubation
Time frame: During anesthesia emergence
Quality of Recovery at 24 Hours Postoperatively as Assessed by the Quality of Recovery-15 (QoR-15) Questionnaire
Time frame: 24 hours after surgery
Perioperative Anxiety Assessed by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Time frame: Day of surgery and postoperative day 2
Composite of Major Organ Complications (Postoperative Delirium, Acute Kidney Injury, Stroke, Acute Myocardial Infarction, Pulmonary Infection, In-Hospital All-Cause Mortality, Postoperative Length of Stay, and Unplanned Reoperation)
Time frame: From the end of surgery until hospital discharge, an average of 7 days
Incidence of Anesthesia-Related Adverse Events (Composite)
Time frame: perioperative
Length of Stay in the Post-Anesthesia Care Unit (PACU)
Time frame: From PACU admission until PACU discharge readiness, assessed up to 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthesia and Aged, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 5 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact min Yan, doctor (+86 13757118632, zryanmin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Hypotension Burden Measured by the Time-Weighted Average of Mean Arterial Pressure (TWA-MAP) Below an Absolute Threshold (<65 mmHg) or a Relative Threshold (>20% Decrease From Baseline) (time frame: From anesthetic induction through the end of surgery (intraoperative period)). 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 5 Aug 2026.