ERP-Based Research on the Modulation of Remimazolam on Working Memory and Brain Network Mechanisms in Glioma Patients

NCT ID: NCT07109362

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-10
• Study Completion Date: 2026-07-30

Brief Summary

Remimazolam is a novel ultra-short-acting benzodiazepine with extensive evidence supporting its safety and efficacy in clinical anesthesia and sedation. Its perioperative use in patients with glioma is becoming increasingly common. Glioma is the most common primary intracranial tumor and is often associated with neurocognitive impairment, with memory being the most frequently affected domain. Working memory, which integrates temporary storage and information processing, serves as a cognitive workspace. Currently, the impact of anesthetics on neurocognitive function during the perioperative period in glioma patients remains underexplored. This study aims to investigate the effects of remimazolam-induced mild sedation on working memory in healthy subjects and patients with supratentorial glioma by combining behavioral and electrophysiological measurements, focusing on the relationship with the P3b event-related potential amplitude. Furthermore, it explores how remimazolam sedation influences brain network functional connectivity during the encoding, maintenance, and retrieval phases of memory in healthy individuals and patients with supratentorial glioma.

Conditions

Remimazolam Mild Sedation; Healthy Brain and Glioma Brain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy brain group

Group Type: OTHER

mild sedation

Intervention Type: DRUG

In this experiment, all subjects were administered remimazolam via a TCI pump until they reached a state of mild sedation, as indicated by a MOAA/S score of 4.

Glioma brain group

Group Type: OTHER

mild sedation

Intervention Type: DRUG

In this experiment, all subjects were administered remimazolam via a TCI pump until they reached a state of mild sedation, as indicated by a MOAA/S score of 4.

Interventions

mild sedation

In this experiment, all subjects were administered remimazolam via a TCI pump until they reached a state of mild sedation, as indicated by a MOAA/S score of 4.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

A. Healthy brain group:

• Aged 18-65 years;

• Native speakers of Chinese;

• Right-handed; ④ Normal vision or corrected vision; ⑤ Healthy brain patient population scheduled for non-neurosurgical operations and anesthesia B. Glioma brain group
• Aged 18-65 years old;

• Native speakers of Chinese;

• Right-handed; ④ ASA physical status I-II;

• Normal vision or corrected vision;

• Patients with supratentorial glioma who have primary unilateral space-occupying lesions confirmed by CT/MRI and require surgery and anesthesia.

Exclusion Criteria

A. Healthy brain group:

• Allergic to remimazolam or with contraindications to remimazolam (myasthenia gravis, schizophrenia, severe depressive state);

• History of drug abuse or alcoholism;

• History of mental or neurological diseases that prevent cooperation in completing the trial; ④ Pregnant or lactating women;

• Score of mini-mental state examination (MMSE) < 27; ⑥ Past history of intracranial diseases or intracranial surgery

B. Glioma brain group:

• Receiving sedative treatment within 72 hours prior to the study;

• Destruction of cerebral structural integrity such as open head injury or cerebral parenchyma resection;

• Preoperative elevated intracranial pressure requiring mannitol or other intracranial pressure-lowering treatments, or preoperative radiotherapy and chemotherapy;

• History of drug abuse or alcoholism;

• Pregnant or lactating women; ⑥ Mini-Mental State Examination (MMSE) score < 27; ⑦ History of allergic reaction to remimazolam or having contraindications to remimazolam. Remimazolam is a national controlled drug with addictive properties and must be used under the guidance of a doctor; ⑧ Those with other mental or neurological diseases who are unable to cooperate in completing the trial; ⑨ Unsuitable for participating in this study due to other reasons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ruquan Han

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tiantan Hospital

Beijing, , China

Countries

China

Central Contacts

Ruquan Han, MD, PhD

Role: CONTACT

ruquan.han@ccmu.edu.cn

8610-59776660

Facility Contacts

Ruquan Han, M.D., Ph.D

Role: primary

ruquan.han@ccmu.edu.cn

8610-59976660

Other Identifiers

RM20250717

Identifier Type: -

Identifier Source: org_study_id