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Cerebral Blood FlowPhase 3NCT07303985

The Effects of Remimazolam on Cerebral Blood Flow Following General Anesthesia Induction

A Phase 3 study testing Remimazolam and Propofol (Group P) in people with Cerebral Blood Flow, run by Jun Zhang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will enroll 40 subjects aged 18 years or older scheduled for elective surgery under general anesthesia with endotracheal intubation. Basic medical history information will be collected. Subjects will be divided into two groups of 20 each: a remimazolam group and a propofol group. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cerebral Blood Flow
What is being tested?
Remimazolam and Propofol (Group P)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteChina
Study dates
29 Dec 2025to 1 Mar 2026
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who have signed the informed consent form and are willing to comply with the study protoco
  • Age greater than 18 years
  • ASA physical status classification I to II
  • Scheduled for elective surgery
  • Undergoing general anesthesia with endotracheal intubation
  • No history of cerebrovascular disease, carotid artery stenosis, or traumatic brain injury.

Who cannot join

  • History of intracranial lesions, carotid artery stenosis, or traumatic brain injury
  • Allergy or contraindications to remimazolam or propofol.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Fudan University Shanghai Cancer Centre

    Shanghai

Other trials in China

About this study

This study will enroll 40 subjects aged 18 years or older scheduled for elective surgery under general anesthesia with endotracheal intubation. Basic medical history information will be collected. Subjects will be divided into two groups of 20 each: a remimazolam group and a propofol group. The study period will span from one day before surgery to one day after surgery. The study will assess middle cerebral artery cerebral blood flow following general anesthesia induction and postoperative anesthesia recovery.

Read the detailed description

A significant reduction in cerebral blood flow (CBF) frequently occurs following general anesthesia induction. This decrease in CBF can lead to a reduction in the delivery of oxygen and glucose to brain tissue. If the magnitude or duration of this reduction exceeds the compensatory capacity of cerebral autoregulation, it can result in an imbalance between cerebral oxygen supply and demand, thereby increasing the risk of cerebral ischemia and neurological injury. Patients who are elderly, have hypertension, a history of cerebrovascular disease (e.g., stroke, intracranial arterial stenosis), or pre-existing brain injury are at higher risk for pronounced CBF reduction after induction, making them more susceptible to postoperative cognitive dysfunction, exacerbation of existing deficits, or new ischemic events. This underscores the urgent need to identify effective and safe therapeutic strategies to mitigate this risk.

Remimazolam is a novel benzodiazepine agent, structurally derived from midazolam with the introduction of a metabolically labile methyl propionate side chain. It similarly acts on the GABAA receptor, promoting chloride ion influx and inhibiting neuronal electrical activity. Administered intravenously for sedation and hypnosis, it is characterized by rapid onset, short duration of action, rapid recovery, minimal accumulation, and metabolism independent of hepatic or renal pathways. Previous studies indicate that benzodiazepines generally lack significant cardiovascular depressant effects and are associated with a lower incidence of hemodynamic instability during anesthesia induction. However, the specific impact of remimazolam on CBF following general anesthesia induction remains unclear.

Therefore, to further elucidate the effects of this novel benzodiazepine, remimazolam-which reportedly lacks significant cardiovascular depression-on CBF post-induction, we propose the following strategies for our clinical study: (1) compare remimazolam with the commonly used agent propofol for anesthesia induction; (2) administer remimazolam as an intravenous bolus of 0.3 mg/kg and propofol at 2 mg/kg for induction; (3) implement goal-directed fluid management during the peri-induction period; (4) utilize ultrasound to monitor blood flow in the middle cerebral artery; and (5) assess postoperative recovery parameters. Through this comprehensive approach, we aim to determine whether remimazolam offers a protective or optimizing effect on CBF during general anesthesia induction, thereby providing an empirical foundation for its routine clinical use in this context.

Being tested
Remimazolam, Propofol (Group P)
Keywords
Remimazolam, Propofol, Cerebral blood flow

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemimazolamDrug

    Also called Experimental

    Remimazolam is used as the sedative agent during the anesthesia induction period (administer remimazolam as an intravenous bolus of 0.3 mg/kg for induction).

  • Propofol (Group P)Drug

    Also called Comparator

    Propofol is used as the sedative agent during the anesthesia induction period (administer propofol at 2 mg/kg for induction).

Study groups in NCT07303985
Study groupRoleWhat they receive
PropofolOtherPropofol is used as the sedative agent during the anesthesia induction period.
Receives: Drug: Propofol (Group P)
RemimazolamExperimentalRemimazolam is used as the sedative agent during the anesthesia induction period.
Receives: Drug: Remimazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak systolic blood flow velocity (PS)

    Peak systolic blood flow velocity (PS) in the middle cerebral artery following general anesthesia induction (at 1, 3, 5, and 10 minutes after endotracheal intubation). Peak systolic blood flow velocity (PS) is the maximum speed of blood flow recorded during the systolic phase of the cardiac cycle, typically measured in centimeters per second (cm/s). Peak systolic blood flow velocity (PS) normal values are vessel-specific and age-dependent. In healthy adults, the commonly cited reference range for the middle cerebral artery (MCA) is approximately 80-120 cm/s. This value decreases with age. For other intracranial arteries, PS is generally lower (e.g., 40-80 cm/s for vertebrobasilar arteries). Physiological factors like hematocrit and gender also cause minor variations. Clinically, PS values above 140-200 cm/s in the MCA often indicate significant pathology such as vasospasm or stenosis.

    Measured: 1, 3, 5, and 10 minutes after endotracheal intubation.

Secondary outcomes (5)
  1. The resistance index (RI) of the middle cerebral artery

    The resistance index (RI) of the middle cerebral artery (MCA) is a hemodynamic parameter. It reflects downstream cerebrovascular resistance and is defined by the formula: RI = (Peak Systolic Velocity - End-Diastolic Velocity) / Peak Systolic Velocity.

    A normal RI in the MCA for healthy adults typically ranges from 0.50 to 0.70 (or 50-70%). Values are influenced by age, with neonates and infants having higher normal values (often up to 0.80-0.85) which decrease toward adult levels with maturation. In elderly individuals, a slight increase may be observed due to reduced vascular compliance.

    An elevated RI (>0.80) generally indicates increased distal vascular resistance, which can be caused by intracranial hypertension, severe microangiopathy, or brain death. A very low RI (<0.50) may suggest a hyperemic state or proximal stenosis.

    Measured: 1, 3, 5, and 10 minutes after endotracheal intubation

  2. Mean blood flow velocity (MV)

    Mean blood flow velocity (MV), often referred to as Time-Averaged Maximum Velocity (TAMV), is a key hemodynamic parameter measured by Doppler ultrasound. It represents the average speed of the fastest-moving blood cells within a vessel over one complete cardiac cycle.

    For the middle cerebral artery (MCA) in healthy adults, the normal MV typically ranges from 40 to 65 cm/s. This value is age-dependent, being higher in children and gradually decreasing with advancing age. A sustained MV outside this range, particularly when asymmetric compared to the contralateral side, can indicate pathological conditions such as stenosis, hyperemia, or impaired autoregulation. Its calculation integrates both systolic and diastolic flow, making it a stable indicator of overall cerebral perfusion.

    Measured: 1, 3, 5, and 10 minutes after endotracheal intubation

  3. Pulsatility index (PI)

    The Pulsatility Index (PI) is a dimensionless hemodynamic parameter derived from Transcranial Doppler (TCD) ultrasound. It quantifies the pulsatility of the blood flow waveform, reflecting downstream cerebrovascular resistance. It is calculated using the formula: PI = (Peak Systolic Velocity - End-Diastolic Velocity) / Mean Velocity.

    For the middle cerebral artery (MCA) in healthy adults, the normal PI typically ranges from 0.70 to 1.10. Age significantly influences this value; neonates have a much higher normal PI (often >1.50), which decreases to adult levels during childhood. An elevated PI (>1.20) generally indicates increased distal resistance, which can be caused by intracranial hypertension or small vessel disease. Conversely, a very low PI (<0.60) may suggest a hyperdynamic state or proximal stenosis.

    Measured: 1, 3, 5, and 10 minutes after endotracheal intubation

  4. Postoperative recovery time

    post-anesthesia care unit (PACU) length of stay. There is no single universal "normal value" for Post-Anesthesia Care Unit (PACU) length of stay, as it is highly dependent on the type of surgery, anesthesia technique, institutional protocols, and patient-specific factors. For straightforward, outpatient, or minor inpatient surgeries, a typical stay often ranges from 30 minutes to 2 hours. The primary discharge criteria are based on standardized scoring systems, most commonly the Aldrete score or its modifications. Patients must achieve a predetermined score (usually ≥9 out of 10) indicating stable vital signs, adequate oxygenation, intact consciousness, and controlled pain and nausea before discharge to a ward or home. Prolonged stays beyond expected benchmarks are used as a quality indicator to identify and address potential complications like postoperative nausea and vomiting, pain, or hemodynamic instability.

    Measured: During the post-anesthesia care unit (PACU)

  5. Postoperative cognitive score

    Postoperative cognitive score was assessed by the Mini-Mental State Examination, MMSE). MMSE is a standardized, 30-point questionnaire used to screen for cognitive impairment. It assesses five key domains: orientation (to time and place), registration and recall of words, attention and calculation (e.g., serial sevens), language abilities (naming, repetition, comprehension, reading, writing), and visual construction (copying a pentagon).

    Administration involves a trained examiner asking the patient specific questions in a quiet setting, typically taking 5-10 minutes. One point is awarded for each correct task, with a maximum total score of 30.

    Results are interpreted based on the total score: 27-30 suggests normal cognition, 24-26 indicates mild cognitive impairment, 19-23 signifies moderate impairment, and a score ≤18 points to severe impairment.

    Measured: On the first postoperative day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2025
  2. Study start29 Dec 2025
  3. Primary completion28 Feb 2026
  4. Study completion1 Mar 2026

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07303985
Sponsor's protocol ID
2510-Exp296
Status last verified
Apr 2026
First submitted
12 Dec 2025
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data sets are available from the corresponding author on reasonable request

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remimazolam and Propofol (Group P) in people with Cerebral Blood Flow, run by Jun Zhang 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 2 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 15 Apr 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Peak systolic blood flow velocity (PS) (time frame: 1, 3, 5, and 10 minutes after endotracheal intubation.). 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 15 Apr 2026.

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