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

NCT07303985 | Completed Phase 3 DMC

• 1 other identifier: 2510-Exp296
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cerebral Blood Flow

Keywords

Remimazolam; Propofol; Cerebral blood flow

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• The resistance index (RI) of the middle cerebral artery

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

• Mean blood flow velocity (MV)

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

• Pulsatility index (PI)

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

• Postoperative recovery time

  During the post-anesthesia care unit (PACU)

• Postoperative cognitive score

  On the first postoperative day.

Study Arms (2)

Propofol

OTHER

Propofol is used as the sedative agent during the anesthesia induction period.

Drug: Propofol (Group P)

Remimazolam

EXPERIMENTAL

Remimazolam is used as the sedative agent during the anesthesia induction period.

Drug: Remimazolam

Interventions

Remimazolam DRUG

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).

Also known as: Experimental

Remimazolam

Propofol (Group P) DRUG

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

Also known as: Comparator

Propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Jun Zhang: lead

Study Sites (1)

Fudan University Shanghai Cancer Centre

Shanghai, China

Location

MeSH Terms

Interventions

remimazolam; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jun Zhang

  Fudan University Shanghai Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start: December 29, 2025
• Primary Completion: February 28, 2026
• Study Completion: March 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)