ChiCTR2600118864 版本V1.0 版本创建时间2026/02/11 18:49:30 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600118864 

最近更新日期：

Date of Last Refreshed on：

 2026-02-11 18:49:25 

注册时间：

Date of Registration：

 2026-02-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于多模态磁共振对瑞马唑仑麻醉前后脑功能变化及机制研究

Public title：

Study on the changes and mechanisms of brain function before and after remazolam anesthesia based on multi-modal magnetic resonance

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于多模态磁共振对瑞马唑仑麻醉前后脑功能变化及机制研究

Scientific title：

Study on the changes and mechanisms of brain function before and after remazolam anesthesia based on multi-modal magnetic resonance

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

肖晖 

研究负责人：

肖晖 

Applicant：

Xiao hui 

Study leader：

Xiao hui 

申请注册联系人电话：

Applicant telephone：

 +86 185 0915 0059

研究负责人电话：

Study leader's
telephone：

+86 185 0915 0059

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 171987535@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 171987535@qq.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

陕西省安康市汉滨区金洲南路85号

研究负责人通讯地址：

陕西省安康市汉滨区金洲南路85号

Applicant address：

No. 85, Jinzhou South Road, Hanbin District, Ankang

Study leader's address：

No. 85, Jinzhou South Road, Hanbin District, Ankang

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

陕西省安康市中心医院

Applicant's institution：

Shaanxi Ankang Central Hospital

研究负责人所在单位：

陕西省安康市中心医院

Affiliation of the Leader：

Shaanxi Ankang Central Hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 AKZXEC-SC-KY2026-016-01

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

安康市中心医院临床研究伦理委员会

Name of the ethic committee：

Ankang Central Hospital Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-02-10 00:00:00

伦理委员会联系人：

王慧姣

Contact Name of the ethic committee：

Wanghuijiao

伦理委员会联系地址：

安康市汉滨区金州南路85号

Contact Address of the ethic committee：

No. 85, Jinzhou South Road, Hanbin District, Ankang

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 187 2985 5130

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

陕西省安康市中心医院

Primary sponsor：

Shaanxi Ankang Central Hospital

研究实施负责（组长）单位地址：

安康市汉滨区金州南路85号

Primary sponsor's address：

No. 85, Jinzhou South Road, Hanbin District, Ankang

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

陕西省

市(区县)：

安康市汉滨区

Country：

China

Province：

Shaanxi

City：

Hanbin District, Ankang

单位(医院)：

安康市中心医院

具体地址：

安康市汉滨区金州南路85号

Institution
hospital：

Ankang Central Hospital

Address：

No. 85, Jinzhou South Road, Hanbin District, Ankang

经费或物资来源：

自筹

Source(s) of funding：

Self-financing

研究疾病：

无  

Target disease：

None

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

病例研究 

Study design：

Case study 

研究目的：

本项目创新性使用多模态MRI 观察新型镇静药瑞马唑仑对睡眠相关脑区的影响，并且将脑区FC 差异数据与记忆量表评估做相关性分析研究，目的在于全面探讨瑞马唑仑在诱导镇静状态时对受试者大脑睡眠脑区功能及记忆认知能力可能的影响，有助于揭示药物作用下的脑神经功能变化与被试记忆认知状态的联系，为深入探讨药物药理机制及临床应用提供更为全面的视角，探索该药物治疗睡眠障碍的临床价值。  

Objectives of Study：

This project innovatively uses multi-modal MRI to observe the impact of the new sedative drug remimazolam besylate on sleep-related brain areas, and combines brain areas FC The purpose of correlation analysis between differential data and memory scale assessment is to comprehensively explore the possible impact of remimazolam on the sleep brain area function and memory cognitive ability of subjects when inducing a sedative state, which will help to reveal the connection between the changes in brain nerve function under the action of the drug and the subjects' memory and cognitive status, provide a more comprehensive perspective for in-depth exploration of the pharmacological mechanism and clinical application of the drug, and explore the clinical value of the drug in treating sleep disorders.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1: ? 年龄18-65岁； 2: ? 健康志愿者，自愿受试并签署知情同意书； 3: ? 无神经系统慢性病史； 4: ? 无颅脑，脊髓创伤及手术史； 5: ? 无幽闭恐惧症， 6: ? 无睡眠暂停综合症； 7: ? ASA评分Ⅰ-Ⅱ级；18 kg/m2＜BMI＜30 kg/m2；

Inclusion criteria

1: ? Age 18 to 65 years 2: ? Healthy volunteers, voluntarily participated in the experiment and signed the informed consent form; 3: ? No history of neurological chronic disease; 4: ? No history of craniocerebral or spinal cord trauma or surgery 5: ? No claustrophobia 6: ? No sleep apnea syndrome; 7: ? ASAI-II;18 kg/m2

排除标准：

1: ? 不能配合完成量表评估者； 2: ? 体内有金属植入物或其他原因不能完成MRI 检查者； 3: ? 对苯磺酸瑞马唑仑或其他药物成分过敏者； 4: ? 妊娠期、哺乳期女性 5: ? 近 3 个月内参与过其他临床研究者。

Exclusion criteria：

1: ? Those who are unable to cooperate in completing the scale assessment; 2: ? Those who have metal implants in their bodies or are unable to complete the MRI examination for other reasons; 3: ? Those allergic to remimazolam besylate or drug ingredients; 4: ? Pregnant and lactating women 5: ? Participated in other clinical researchers within the past 3 months.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2027-02-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-02-12 00:00:00 至 To 2026-07-01 00:00:00

干预措施：

Interventions：

组别：

观察组

样本量：

 50

Group：

Observation group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 陕西省 

市(区县)：

 安康市汉滨区 

Country：

China

Province：

Shaanxi

City：

Hanbin District, Ankang

单位(医院)：

 安康市中心医院 

单位级别：

 三甲 

Institution
hospital：

Ankang Central Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

扩散张量成像（DTI）

指标类型：

次要指标

Outcome：

Diffusion Tensor imaging(DTI)

Type：

Secondary indicator

测量时间点：

清醒状态（RASS 评分 0）下进行一次扫描。

测量方法：

所有被试者均在我院医学影像中心完成。使用美国GEArchitect 3.0T MRI 磁共振成像系统，安装头部固定器以减少被试者头动，扫描时不用任何认知任务，被试者闭上双眼，保持安静仰卧位。

Measure time point of outcome：

The first MRI scan was performed while awake (RASS score 0)

Measure method：

All participants completed the procedures at the medical imaging center of our hospital.Examinations were performed using a GE Architect 3.0T MRI system. A head coil was employed to minimize head motion. During scanning, no cognitive tasks were administered. Participants were instructed to remain still in a supine position with their eyes closed.

指标中文名：

语言流畅性测试

指标类型：

主要指标

Outcome：

Verbal fluency including phonemic and semantic fluency was evaluated through the Verbal Fluency Test (VFT)

Type：

Primary indicator

测量时间点：

被试者静脉注射瑞马唑仑前后各测量一次

测量方法：

由受过专业培训的量表评估师分别在被试用药前清醒状态测量一次，用药后苏醒30分钟以内再次测量一次。

Measure time point of outcome：

Measure method：

Professionally trained scale assessors measured the subjects once when they were awake before taking the drug, and again within 30 minutes of waking up after taking the drug.

指标中文名：

贝克焦虑量表

指标类型：

主要指标

Outcome：

Beck Anxiety Inventory (BAI)

Type：

Primary indicator

测量时间点：

被试者静脉注射瑞马唑仑前后各测量一次

测量方法：

由受过专业培训的量表评估师分别在被试用药前清醒状态测量一次，用药后苏醒30分钟以内再次测量一次。

Measure time point of outcome：

The subjects were measured once before and after intravenous remimazolam

Measure method：

Professionally trained scale assessors measured the subjects once when they were awake before taking the drug, and again within 30 minutes of waking up after taking the drug.

指标中文名：

三维T1加权核磁成像(3DT1）

指标类型：

主要指标

Outcome：

3DT1-weighted Magnetic Resonance lmaging

Type：

Primary indicator

测量时间点：

清醒状态（RASS 评分 0）下进行一次扫描。

测量方法：

所有被试者均在我院医学影像中心完成。使用美国GEArchitect 3.0T MRI 磁共振成像系统，安装头部固定器以减少被试者头动，扫描时不用任何认知任务，被试者闭上双眼，保持安静仰卧位。

Measure time point of outcome：

The first rs-fMRI scan was performed while awake (RASS score 0).

Measure method：

All participants completed the procedures at the medical imaging center of our hospital.Examinations were performed using a GE Architect 3.0T MRI system. A head coil was employed to minimize head motion. During scanning, no cognitive tasks were administered. Participants were instructed to remain still in a supine position with their eyes closed. : : Outcome:Trail Making Test ,TMT : : Timepoint:The subjects were measured once before and after intravenous

指标中文名：

数字连线测试

指标类型：

主要指标

Outcome：

Trail Making Test ,TMT

Type：

Primary indicator

测量时间点：

被试者静脉注射瑞马唑仑前后各测量一次

测量方法：

由受过专业培训的量表评估师分别在被试用药前清醒状态测量一次，用药后苏醒30分钟以内再次测量一次。

Measure time point of outcome：

The subjects were measured once before and after intravenous remimazolam

Measure method：

Professionally trained scale assessors measured the subjects once when they were awake before taking the drug, and again within 30 minutes of waking up after taking the dr

指标中文名：

血氧水平依赖成像（BOLD)

指标类型：

主要指标

Outcome：

Blood Oxygenation Level Dependent Magnetic Resonance lmaging

Type：

Primary indicator

测量时间点：

清醒状态（RASS 评分 0） 下进行第一次 MRI 扫描，在静注瑞马唑仑 0.15mg/kg 镇静后（RASS 评分-3 至-4）进行第二次 MRI 扫描

测量方法：

所有被试者均在我院医学影像中心完成。使用美国GEArchitect 3.0T MRI 磁共振成像系统，安装头部固定器以减少被试者头动，扫描时不用任何认知任务，被试者闭上双眼，保持安静仰卧位。

Measure time point of outcome：

The first rs-fMRI scan was performed while awake (RASS score 0), and the second MRI scan was perform

Measure method：

All participants completed the procedures at the medical imaging center of our hospital.Examinations were performed using a GE Architect 3.0T MRI system. A head coil was employed to minimize head motion. During scanning, no cognitive tasks were administered. Participants were instructed to remain still in a supine position with their eyes closed.

指标中文名：

动脉自旋标记磁共振成像（ASL）

指标类型：

次要指标

Outcome：

rial Spin Labeling Magnetic Resonance lmaging

Type：

Secondary indicator

测量时间点：

清醒状态（RASS 评分 0） 下进行第一次动脉自旋标记磁共振成像（ASL）扫描，在静注瑞马唑仑 0.15mg/kg 镇静后（RASS 评分-3 至-4）进行第二次扫描

测量方法：

所有被试者均在我院医学影像中心完成。使用美国GEArchitect 3.0T MRI 磁共振成像系统，安装头部固定器以减少被试者头动，扫描时不用任何认知任务，被试者闭上双眼，保持安静仰卧位。

Measure time point of outcome：

The first rs-fMRI scan was performed while awake (RASS score 0), and the second scan was perform

Measure method：

All participants completed the procedures at the medical imaging center of our hospital.Examinations were performed using a GE Architect 3.0T MRI system. A head coil was employed to minimize head motion. During scanning, no cognitive tasks were administered. Participants were instructed to remain still in a supine position with their eyes closed.

指标中文名：

数字符号测验

指标类型：

主要指标

Outcome：

Digit Symbol Coding Task (DSC)

Type：

Primary indicator

测量时间点：

被试者静脉注射瑞马唑仑前后各测量一次

测量方法：

由受过专业培训的量表评估师分别在被试用药前清醒状态测量一次，用药后苏醒30分钟以内再次测量一次。

Measure time point of outcome：

The subjects were measured once before and after taking the medication.

Measure method：

Professionally trained scale assessors measured the subjects once when they were awake before taking the drug, and again within 30 minutes of waking up after taking the drug

指标中文名：

韦氏逻辑记忆--即刻

指标类型：

主要指标

Outcome：

Wechsler Memory Scale Logical Memory (WMS LM)instant

Type：

Primary indicator

测量时间点：

被试者静脉注射瑞马唑仑前后各测量一次

测量方法：

由受过专业培训的量表评估师分别在被试用药前清醒状态测量一次，用药后苏醒30分钟以内再次测量一次。

Measure time point of outcome：

The subjects were measured once before and after intravenous remimazolam

Measure method：

Professionally trained scale assessors measured the subjects once when they were awake before taking the drug, and again within 30 minutes of waking up after taking the drug.

指标中文名：

韦氏逻辑记忆--延迟

指标类型：

主要指标

Outcome：

Wechsler Memory Scale Logical Memory (WMS LM)delay recall

Type：

Primary indicator

测量时间点：

被试者静脉注射瑞马唑仑前后各测量一次

测量方法：

由受过专业培训的量表评估师分别在被试用药前清醒状态测量一次，用药后苏醒30分钟以内再次测量一次。

Measure time point of outcome：

The subjects were measured once before and after intravenous remimazolam

Measure method：

Professionally trained scale assessors measured the subjects once when they were awake before taking the drug, and again within 30 minutes of waking up after taking the drug.

指标中文名：

健康状况问卷

指标类型：

主要指标

Outcome：

Patient Health

Type：

Primary indicator

测量时间点：

被试者静脉注射瑞马唑仑前后各测量一次

测量方法：

由受过专业培训的量表评估师分别在被试用药前清醒状态测量一次，用药后苏醒30分钟以内再次测量一次。

Measure time point of outcome：

The subjects were measured once before and after intravenous remimazolam

Measure method：

Professionally trained scale assessors measured the subjects once when they were awake before taking the drug, and again within 30 minutes of waking up after taking the drug.

指标中文名：

疼痛模拟评分

指标类型：

主要指标

Outcome：

Pain simulation rating.

Type：

Primary indicator

测量时间点：

被试者静脉注射瑞马唑仑前后各测量一次

测量方法：

由受过专业培训的量表评估师分别在被试用药前清醒状态测量一次，用药后苏醒30分钟以内再次测量一次。

Measure time point of outcome：

The subjects were measured once before and after intravenous remimazolam

Measure method：

Professionally trained scale assessors measured the subjects once when they were awake before taking the drug, and again within 30 minutes of waking up after taking the drug.

指标中文名：

头痛影响测试问卷

指标类型：

主要指标

Outcome：

Headache Impact Test

Type：

Primary indicator

测量时间点：

被试者静脉注射瑞马唑仑前后各测量一次

测量方法：

由受过专业培训的量表评估师分别在被试用药前清醒状态测量一次，用药后苏醒30分钟以内再次测量一次。

Measure time point of outcome：

The subjects were measured once before and after intravenous remimazolam

Measure method：

Professionally trained scale assessors measured the subjects once when they were awake before taking the drug, and again within 30 minutes of waking up after taking the drug.

指标中文名：

简易精神状态检查量表

指标类型：

主要指标

Outcome：

Mini-Mental State Examination (MMSE)

Type：

Primary indicator

测量时间点：

被试者静脉注射瑞马唑仑前后各测量一次

测量方法：

由受过专业培训的量表评估师分别在被试用药前清醒状态测量一次，用药后苏醒30分钟以内再次测量一次。

Measure time point of outcome：

The subjects were measured once before and after intravenous remimazolam

Measure method：

Professionally trained scale assessors measured the subjects once when they were awake before taking the drug, and again within 30 minutes of waking up after taking the drug.

指标中文名：

失眠严重程度指数量表

指标类型：

主要指标

Outcome：

Insomnia Severity Index Scale

Type：

Primary indicator

测量时间点：

被试者静脉注射瑞马唑仑前后各测量一次

测量方法：

由受过专业培训的量表评估师分别在被试用药前清醒状态测量一次，用药后苏醒30分钟以内再次测量一次。

Measure time point of outcome：

The subjects were measured once before and after intravenous remimazolam

Measure method：

Professionally trained scale assessors measured the subjects once when they were awake before taking the drug, and again within 30 minutes of waking up after taking the drug.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

无

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

None

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-02-11 18:49:25