ChiCTR2500113969 版本V1.0 版本创建时间2025/12/04 17:33:07 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：

ChiCTR2500113969 

最近更新日期：

Date of Last Refreshed on：

2025-12-04 17:32:52 

注册时间：

Date of Registration：

2025-12-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

11·（审核员标记请勿删除；修改完，请回复邮件到chictr-s1@wchscu.cn；1、目前上传的知情同意的版本号是6.0，但是伦理审批只审核到5.0，请重新核对；2、如尚无参试者入组，可适当后延征募参试者时间起始时间，建议为修改完成日期之后的5天以上，以免成为补注册。3、请在干预措施中描述交叉方式；4、建议注册所留联系电话都留为座机电话，以免信息泄露，仅作提醒，不涉及请忽略；）咪达唑仑与丙泊酚中度镇静对健康志愿者镇静恢复时间的影响：一项基于fMRI-EEG的单中心、单盲、随机交叉对照试验

Public title：

Midazolam versus Propofol for Moderate Sedation: Effects on Sedation Recovery Time in Healthy Volunteers – A Single-Center, Single-Blind, Randomized Crossover Trial Using fMRI-EEG

注册题目简写：

咪达唑仑与丙泊酚中度镇静对健康志愿者镇静恢复时间的影响：一项fMRI-EEG随机交叉研究?

English Acronym：

??Recovery After Midazolam vs. Propofol Sedation: An fMRI-EEG Randomized Crossover Study

研究课题的正式科学名称：

咪达唑仑与丙泊酚中度镇静对健康志愿者镇静恢复时间的影响：一项基于fMRI-EEG的单中心、单盲、随机交叉对照试验

Scientific title：

??Effects of Midazolam versus Propofol-induced Moderate Sedation on Recovery Time in Healthy Volunteers: A Single-center, Single-blind, Randomized Crossover Controlled Trial Using fMRI-EEG?

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：

汪燕 

研究负责人：

张鸿飞 

Applicant：

Yan Wang 

Study leader：

Hong fei Zhang 

申请注册联系人电话：

Applicant telephone：

+86 20 6278 7271

研究负责人电话：

Study leader's telephone：

+86 20 6278 7271

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：

Miawang020@outlook.com

研究负责人电子邮件：

Study leader's E-mail：

zhanghongfei@smu.edu.cn

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：

广州市海珠区工业大道中253号南方医科大学珠江医院

研究负责人通讯地址：

广州市海珠区工业大道中253号南方医科大学珠江医院

Applicant address：

Department of Anesthesiology, Zhujiang Hospital, Southern Medical University, Guangzhou 510280, China

Study leader's address：

Department of Anesthesiology, Zhujiang Hospital, Southern Medical University, Guangzhou 510280, China

申请注册联系人邮政编码：

Applicant postcode：

510282

研究负责人邮政编码：

Study leader's postcode：

510282

申请人所在单位：

南方医科大学珠江医院

Applicant's institution：

Zhujiang Hospital, Southern Medical University

研究负责人所在单位：

南方医科大学珠江医院

Affiliation of the Leader：

Zhujiang Hospital, Southern Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2025-KY-393-01

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：

南方医科大学珠江医院医学伦理委员会

Name of the ethic committee：

The Medical Ethics Committee of Zhujiang Hospital, Southern Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-10-23 00:00:00

伦理委员会联系人：

黄熙华

Contact Name of the ethic committee：

Xihua Huang

伦理委员会联系地址：

广州市工业大道中253号

Contact Address of the ethic committee：

No. 253, Gongye Dadao Zhong, Guangzhou, Guangdong Province, China, 510280

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 20 6278 2857

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：

南方医科大学珠江医院

Primary sponsor：

Zhujiang Hospital, Southern Medical University?

研究实施负责（组长）单位地址：

广州市海珠区工业大道中253号南方医科大学珠江医院

Primary sponsor's address：

Department of Anesthesiology, Zhujiang Hospital, Southern Medical University, Guangzhou 510280, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东

市(区县)：

广州

Country：

China

Province：

Guang Dong

City：

Guang Zhou

单位(医院)：

南方医科大学珠江医院

具体地址：

广州市海珠区工业大道中253号南方医科大学珠江医院

Institution
hospital：

Zhujiang Hospital, Southern Medical University?

Address：

Department of Anesthesiology, Zhujiang Hospital, Southern Medical University, Guangzhou 510280, China

经费或物资来源：

自筹经费

Source(s) of funding：

Self-funding?

Target disease：

Procedures such as GI endoscopy and MRI performed in outpatient settings?

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机交叉对照 

Study design：

Cross-over 

研究目的：

比较咪达唑仑与丙泊酚在健康志愿者中度镇静后的镇静恢复时间，明确两种药物在恢复时间上的差异，为临床实践中选择更优的镇静药物提供依据。  

Objectives of Study：

This study aims to compare midazolam and propofol in terms of sedation recovery time following moderate sedation in healthy volunteers. The objective is to clarify the differences in recovery time between the two agents, thereby providing evidence for selecting the superior sedative in clinical practice.

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. 本院近 3 个月内健康体检者，且经该体检（含血常规、肝肾功能、心电图、胸部 X 线等基础项目）确认无明确心、肝、肾、中枢神经系统等基础疾病； 2. 年龄18–35周岁，男女均可； 3. BMI（body mass index） 18–27 kg·m^2； 4. ASA（American Society of Anesthesiologists） 分级为I-II级； 5. 右利手，母语为汉语； 6. 无重大躯体或精神疾病史； 7. 无MRI禁忌（如无金属植入、无幽闭恐惧症）。

Inclusion criteria

1. Healthy individuals who underwent a health check-up at this hospital within the last 3 months, with no significant underlying diseases (e.g., cardiovascular, hepatic, renal, or central nervous system disorders) confirmed by the check-up (including basic items such as complete blood count, liver and kidney function tests, electrocardiogram, and chest X-ray); 2. Aged 18–35 years, regardless of gender; 3. BMI (Body Mass Index) between 18–27 kg·m^2; 4. ASA (American Society of Anesthesiologists) physical status classification of I-II; 5. Right-handed, with Mandarin Chinese as their native language; 6. No history of major physical or mental illnesses; 7. No contraindications for MRI (e.g., no metal implants, no claustrophobia).

排除标准：

1. 既往头外伤、癫痫或意识障碍史； 2. 长期服药、药物或酒精依赖； 3. 妊娠、哺乳或计划半年内妊娠； 4. 肝肾功能异常、哮喘或气道高反应性； 5. 动脉穿刺禁忌或凝血功能障碍。

Exclusion criteria：

1. History of head trauma, epilepsy, or impaired consciousness; 2. Long-term medication use, or dependence on drugs or alcohol; 3. Pregnancy, lactation, or planning pregnancy within the next six months; 4. Abnormal liver or kidney function, asthma, or airway hyperresponsiveness; 5. Contraindications to arterial puncture or coagulopathy.

研究实施时间：

Study execute time：

从 From 2025-12-20 00:00:00至 To 2027-12-12 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-12-20 00:00:00 至 To 2027-12-12 00:00:00  

干预措施：

Interventions：

组别：

咪达唑仑组

样本量：

24

Group：

the midazolam group

Sample size：

干预措施：

基线清醒期 (T0)：单次静脉注射 2 mL 生理盐水作为安慰剂对照。 中度镇静期 (T1)： 单次静脉注射咪达唑仑，初始剂量为 0.06 mg/kg，通过滴定法达到中度镇静效果（OAA/S 评分 ≤ 3 分）。累计剂量不超过 0.12 mg/kg。 本干预方案采用两周期交叉设计实施。具体流程如下：符合入组条件的健康志愿者按入组顺序获得唯一ID编号，并依据随机数表分配至不同序列。被随机分配至序列A的受试者，将在第一周期接受上述咪达唑仑干预方案；被随机分配至序列B的受试者，则在第二周期接受该干预。每个研究周期均包含基线清醒期（T0）与药物镇静期（T1），并同步采集fMRI-EEG数据。两个周期之间设有1周的洗脱期，以彻底消除前一周期药物的残留效应，避免携带效应干扰。本研究全程采用单盲设计，确保受试者对当次干预药物不知情。通过此设计，所有受试者均会在一个周期接受咪达唑仑，另一周期接受丙泊酚，从而作为自身对照，实现两种药物的比较。

干预措施代码：

Intervention：

Midazolam group: Baseline awake period (T0): Received a single intravenous injection of 2 mL normal saline as a placebo control. Moderate sedation period (T1): Received a single intravenous injection of midazolam at an initial dose of 0.06 mg/kg, titrated to achieve moderate sedation (OAA/S score ≤ 3). The cumulative dose did not exceed 0.12 mg/kg. This interventional protocol was implemented using a two-period crossover design. The specific procedure is as follows: eligible healthy volunteers were assigned unique ID numbers according to their enrollment sequence and allocated to different sequences based on a randomization table. Subjects randomly assigned to Sequence A received the aforementioned midazolam intervention regimen in the first period, while those randomly assigned to Sequence B received the same intervention in the second period. Each study period included a baseline awake phase (T0) and a drug-induced sedation phase (T1), with synchronous fMRI-EEG data acquisition throughout. A 1-week washout period was established between the two periods to thoroughly eliminate residual effects from the previous period's drug and avoid carryover effects. The study employed a single-blind design throughout, ensuring subjects remained unaware of the specific intervention drug administered in each period. Through this design, all subjects received midazolam in one period and propofol in the other, thereby serving as their own controls to enable comparison of the two drugs.

Intervention code：

组别：

丙泊酚组

样本量：

24

Group：

the propofol group

Sample size：

干预措施：

基线清醒期 (T0)：单次静脉注射 2 mL 生理盐水作为安慰剂对照。 中度镇静期 (T1)：采用靶控输注（TCI）方式静脉注射丙泊酚，设定血浆靶浓度为 2.0 μg/mL，以诱导并维持中度镇静（OAA/S 评分 ≤ 3 分）。允许进行浓度微调（±0.2 μg/mL），最多调整2次。 本干预方案采用两周期交叉设计实施。具体流程如下：符合入组条件的健康志愿者按入组顺序获得唯一ID编号，并依据随机数表分配至不同序列。被随机分配至序列B的受试者，将在第一周期接受上述丙泊酚干预方案；被随机分配至序列A的受试者，则在第二周期接受该干预。每个研究周期均包含基线清醒期（T0）与药物镇静期（T1），并同步采集fMRI-EEG数据。两个周期之间设有1周的洗脱期，以彻底消除前一周期药物的残留效应，避免携带效应干扰。本研究全程采用单盲设计，确保受试者对当次干预药物不知情。通过此设计，所有受试者均会在一个周期接受丙泊酚，另一周期接受咪达唑仑，从而作为自身对照，实现两种药物的比较。

干预措施代码：

Intervention：

Baseline awake period (T0): Received a single intravenous injection of 2 mL normal saline as a placebo control. Moderate sedation period (T1): Administered propofol via target-controlled infusion (TCI) with a plasma target concentration set at 2.0 μg/mL to induce and maintain moderate sedation (OAA/S score ≤ 3). Adjustments of ±0.2 μg/mL were permitted, up to a maximum of two adjustments. This intervention plan is implemented using a two-period crossover design. The specific procedure is as follows: eligible healthy volunteers are assigned unique ID numbers according to their enrollment sequence and allocated to different sequences based on a randomization table. Subjects randomly assigned to Sequence B receive the propofol intervention plan described above in the first period, while those randomly assigned to Sequence A receive this intervention in the second period. Each study period includes a baseline awake phase (T0) and a drug-induced sedation phase (T1), with synchronous fMRI-EEG data acquisition. A 1-week washout period is established between the two periods to thoroughly eliminate residual effects from the previous period's drug and avoid carryover effects. This study employs a single-blind design throughout, ensuring subjects remain unaware of the specific intervention drug administered in each period. Through this design, all subjects receive propofol in one period and midazolam in the other, thereby serving as their own controls to achieve comparison of the two drugs.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

 广州 

Country：

China 

Province：

Guangdong Sheng 

City：

Guangzhou 

单位(医院)：

南方医科大学珠江医院 

单位级别：

三甲 

Institution
hospital：

Zhujiang Hospital, Southern Medical University?

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

镇静恢复时间

指标类型：

主要指标

Outcome：

Sedation Recovery Time

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

中度镇静状态下脑功能网络（如默认模式网络、执行控制网络）的功能连接强度变化

指标类型：

次要指标

Outcome：

Changes in functional connectivity strength of brain networks (e.g., the default mode network and executive control network) under moderate sedation.?

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

镇静期间不良事件发生率

指标类型：

副作用指标

Outcome：

Incidence of adverse events during sedation

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

上肢静脉

Sample Name：

Blood

Tissue：

Department of Anesthesiology, Zhujiang Hospital, Southern Medical University, Guangzhou 510280, China

人体标本去向

 使用后销毁  

说明

保存2年，然后销毁

Fate of sample：

Destruction after use  

Note：

Retain for two years and then destroy

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 35 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）：

随机序列的产生：?? 由不参与受试者招募、分组与干预的独立生物统计学家，使用统计软件SPSS（版本26.0）生成随机数字序列。该序列规定了受试者的组别分配（咪达唑仑组或丙泊酚组），其生成过程与受试者的招募入组完全独立。

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

Generation of the random sequence:?? The random allocation sequence was generated by an independent biostatistician who was not involved in participant recruitment, grouping, or intervention. The sequence, which determined participant assignment to either the midazolam or propofol group, was produced using the SPSS software (version 26.0). The generation process was conducted independently of and prior to participant enrollment.

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：

盲法的实施：?? 本研究为单盲设计，即受试者（志愿者）对分组情况设盲，而研究者（包括麻醉医师和结果评估者）知晓分组信息。 ??具体措施：?? ??对受试者设盲：?? 在试验的镇静干预阶段（T1期），两组受试者均在接受静脉输注的情况下，同步进行脑功能磁共振（fMRI-EEG）数据采集。输注药物（咪达唑仑或丙泊酚）由不参与结果评估的麻醉医师在磁共振室外通过靶控输注泵（丙泊酚组）或使用注射器（咪达唑仑组）进行给药。此操作流程使受试者无法通过观察输液泵屏幕或注射器中药物的外观（两种药物均为无色透明液体）来获知自己所接受的具体药物，从而成功实现设盲。 ??研究者设盲情况：?? 由于两种药物的给药方案（单次推注 vs. 靶控输注）和监护要求不同，负责给药和保障患者安全的麻醉医师无法设盲。同样，主要结局指标（镇静恢复时间）为客观指标，受试者的生理数据采集由设备自动完成，最大程度减少了评估者知晓分组信息可能带来的偏倚。

Blinding：

Blinding:?? This study employed a single-blind design, wherein the participants (volunteers) were blinded to group assignment, while the investigators (including the anesthesiologists and outcome assessors) were unblinded. ??Specific Procedures:?? ??Blinding of Participants:?? During the sedation intervention phase (T1), all participants underwent synchronous fMRI-EEG data acquisition while receiving an intravenous infusion. The study drugs (midazolam or propofol) were administered by an anesthesiologist (not involved in outcome assessment) outside the MRI room using a target-controlled infusion pump (for the propofol group) or a syringe (for the midazolam group). This procedure ensured that participants were unable to identify the assigned drug by observing the infusion pump screen or the appearance of the drug in the syringe (as both drugs are colorless, clear liquids), thereby successfully maintaining blinding. ??Blinding of Investigators:?? Due to the distinct administration protocols (bolus injection vs. target-controlled infusion) and monitoring requirements for the two drugs, the anesthesiologists responsible for drug delivery and patient safety were necessarily unblinded. However, the primary outcome (sedation recovery time) is an objective measure, and the collection of physiological data was automated, minimizing potential assessment bias.

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

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：

病例记录表

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

CRF

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：

  2025-12-04 17:32:52