ChiCTR2500097787 版本V1.0 版本创建时间2025/02/25 16:50:42 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：

 ChiCTR2500097787 

最近更新日期：

Date of Last Refreshed on：

 2025-02-25 16:50:24 

注册时间：

Date of Registration：

 2025-02-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

全身麻醉下升压药物对颈动脉内膜剥脱术患者脑氧饱和度的影响

Public title：

Effects of vasopressors on cerebral oxygen saturation in patients undergoing carotid endarterectomy under general anesthesia

注册题目简写：

升压药物对CEA患者脑氧饱和度的影响

English Acronym：

Effects of vasopressors on cerebral oxygen saturation in patients undergoing CEA.

研究课题的正式科学名称：

全身麻醉下升压药物对颈动脉内膜剥脱术患者脑氧饱和度的影响

Scientific title：

Effects of vasopressors on cerebral oxygen saturation in patients undergoing carotid endarterectomy under general anesthesia

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：

李桂宇 

研究负责人：

刘海洋/李桂宇 

Applicant：

Li Guiyu 

Study leader：

Liu Haiyang/ Li Guiyu 

申请注册联系人电话：

Applicant telephone：

 +86 183 0974 2778

研究负责人电话：

Study leader's
telephone：

+86 136 5106 8281

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：

 1158751742@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 oceantth@163.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：

青海省西宁市城西区同仁路29号青海大学附属医院麻醉科

研究负责人通讯地址：

北京市丰台区南四环西路119号首都医科大学附属北京天坛医院/ 青海省西宁市城西区同仁路29号青海大学附属医院麻醉科

Applicant address：

Department of Anesthesiology, Affiliated Hospital of Qinghai University, No. 29 Tongren Road, Chengxi District, Xining City, Qinghai Province

Study leader's address：

Beijing Tiantan Hospital Affiliated to Capital Medical University, No. 119, South Fourth Ring Road West, Fengtai District, Beijing/ Department of Anesthesiology, Affiliated Hospital of Qinghai University, No. 29 Tongren Road, Chengxi District, Xining City, Qinghai Province

申请注册联系人邮政编码：

Applicant postcode：

 810000

研究负责人邮政编码：

Study leader's postcode：

 100070

申请人所在单位：

青海大学附属医院麻醉科

Applicant's institution：

Anesthesia Department, Qinghai University Affiliated Hospital

研究负责人所在单位：

首都医科大学附属北京天坛医院麻醉科/青海大学附属医院麻醉科

Affiliation of the Leader：

Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University/ Anesthesia Department, Qinghai University Affiliated 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：

 P-SL-2024-197

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：

青海大学临床医学院伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Qinghai University School

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-07-25 00:00:00

伦理委员会联系人：

李毅

Contact Name of the ethic committee：

Li Yi

伦理委员会联系地址：

青海省西宁市城西区同仁路29号

Contact Address of the ethic committee：

No. 29, Tongren Road, Chengxi District, Xining City, Qinghai Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 971 392 1307

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：

青海大学附属医院（临床医学院）

Primary sponsor：

Qinghai University Affiliated Hospital (School of Clinical Medicine)

研究实施负责（组长）单位地址：

青海省西宁市城西区同仁路29号

Primary sponsor's address：

No. 29, Tongren Road, Chengxi District, Xining City, Qinghai Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

青海

市(区县)：

西宁

Country：

China

Province：

Qinghai

City：

Xining

单位(医院)：

青海大学附属医院

具体地址：

青海省西宁市城西区同仁路29号

Institution
hospital：

The Affiliated Hospital of Qinghai University

Address：

No. 29, Tongren Road, Chengxi District, Xining City, Qinghai Province

经费或物资来源：

自筹

Source(s) of funding：

self-funded

研究疾病：

缺血性脑血管病  

Target disease：

ischemic cerebrovascular disease

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

近年来各项研究较为关注术中使用药物对脑氧代谢和脑血流动力学的影响。然而，去甲肾上腺素和去氧肾上腺素作为临床常用的升压药，目前探究其对脑氧代谢和脑血流动力学影响的相关研究较少。颈动脉内膜剥脱术（CEA）的患者由于压力反射敏感性和脑自动调节功能均受损，术中极易出现血流动力学不稳定，常需在术中使用血管活性药物来保证患者的脑灌注。本研究旨在通过近红外光谱(NIRS)技术研究去氧肾上腺素和去甲肾上腺素对CEA患者rSO2的影响，初步探索为此后脑血管类手术术中选取适宜的升压药提供依据，同时选出适合CEA的升压药以利于患者围术期循环管理。  

Objectives of Study：

In recent years, various studies have focused on the effects of intraoperative drugs on cerebral oxygen metabolism and cerebral hemodynamics. However, norepinephrine and phenylephrine are commonly used pressors in clinical practice, and there are few studies on their effects on cerebral oxygen metabolism and cerebral hemodynamics. Patients undergoing carotid endarterectomy (CEA) are prone to hemodynamic instability during surgery due to impaired baroreflex sensitivity and cerebral autoregulation, and vasoactive drugs are often used during surgery to ensure cerebral perfusion. This study aims to study the effects of phenylephrine and norepinephrine on rSO2 in patients with CEA using near-infrared spectroscopy (NIRS) technology, and to provide a basis for the selection of appropriate pressors during subsequent cerebrovascular surgeries. At the same time, pressors suitable for CEA are selected to facilitate perioperative circulatory management of patients.

药物成份或治疗方案详述：

本研究选取择期行颈动脉内膜剥脱术患者96例，采用随机数字表法随机分为去氧肾上腺素组（P组，48例）和去甲肾上腺素组（N组，48例）。术前记录患者的基本情况，并进行认知功能的评估。患者入室后建立静脉输液通路，采用心电监护仪的5导联心电图、脉搏血氧仪、无创自动血压袖带进行连续监测，根据监护仪获取心率(heart rate, HR)、脉搏血氧分压(SpO2)、血压（BP），并进行基线血压测定（基线血压定义在入室后安静状态下连续三次测量的平均动脉压均值）。经局部浸润麻醉后，桡动脉穿刺置管持续监测平均动脉血压(mean arterial pressure, MAP)。连接并监测 BIS（Bispectralindex，脑电双频谱指数），使用 NIRS（Near infrared spectroscopy, 近红外光谱）术中持续监测患者rSO2的变化。麻醉诱导开始前给予平衡液进行补偿性扩容，减轻麻醉诱导药物的舒张血管作用。开始行全身麻醉，麻醉诱导采用舒芬太尼（0.5～1 μg/kg），丙泊酚（1.5～2.5mg/kg），以及顺式阿曲库铵（0.1～0.2 mg/kg）。在气管插管后行机械通气，保持PaCO2 35～40mmhg。麻醉维持采用丙泊酚（4～6mg/kg/h）和瑞芬太尼（0.05～0.2μg/kg/min），必要时使用顺式阿曲库铵维持肌肉松弛，BIS维持在40～50。在全身麻醉后10min至生命体征平稳，两组患者分别经静脉泵注升压药，将血压维持在基线水平。当颈动脉钳夹阻断后以目标血压值（基线血压20%以上）调节给药或泵注速度。颈动脉开放时停止升压药的泵注。分别记录不同时间点的rSO2、HR、RR、BP、SpO2、MAP、PetCO2、BIS、麻醉用药及出入量，以及升压药是否达到目标血压、术后苏醒质量。术后评估患者是否谵妄及认知功能。最后整理数据后进行分析，统计学分析采用SPSS软件进行。 

Description for medicine or protocol of treatment in detail：

This study selected 96 patients who underwent carotid endarterectomy and randomly divided them into the phenylephrine group (P group, 48 cases) and the norepinephrine group (N group, 48 cases) by random number table method. The basic information of the patients was recorded before surgery, and cognitive function was evaluated. After entering the room, intravenous infusion access was established for the patients, and continuous monitoring was performed using a 5-lead electrocardiogram, pulse oximeter, and non-invasive automatic blood pressure cuff. The heart rate (heartrate, HR), pulse oxygen partial pressure (SpO2), and blood pressure (BP) were obtained according to the monitor, and baseline blood pressure was measured (baseline blood pressure was defined as the mean of three consecutive mean arterial pressure measurements in a quiet state after entering the room). After local infiltration anesthesia, radial artery puncture and catheterization were used to continuously monitor mean arterial pressure (MAP). BIS (Bispectral index, brain electroencephalogram bispectral index) was connected and monitored, and NIRS (Near infrared spectroscopy, near infrared spectroscopy) was used to continuously monitor the changes in rSO2 of patients during surgery. Before the induction of anesthesia, balanced fluid was given for compensatory volume expansion to reduce the vasodilatory effect of anesthesia induction drugs. General anesthesia was initiated, and sufentanil (0.5-1μg/kg), propofol (1.5-2.5mg/kg), and cisatracurium (0.1-0.2mg/kg) were used for anesthesia induction. Mechanical ventilation was performed after endotracheal intubation to maintain PaCO2 at 35-40mmhg. Propofol (4-6mg/kg/h) and remifentanil (0.05-0.2μg/kg/min) were used for anesthesia maintenance. Cisatracurium was used to maintain muscle relaxation when necessary, and BIS was maintained at 40-50. Ten minutes after general anesthesia until vital signs stabilized, vasopressors were intravenously pumped into the two groups of patients to maintain blood pressure at the baseline level. When the carotid artery was clamped, the drug administration or pumping rate was adjusted according to the target blood pressure value (more than 20% of the baseline blood pressure). The pumping of vasopressors was stopped when the carotid artery was open. rSO2, HR, RR, BP, SpO2, MAP, PetCO2, BIS, anesthetic medication and intake and output at different time points, whether the vasopressor reached the target blood pressure, and the quality of postoperative recovery were recorded. The patients were evaluated for delirium and cognitive function after surgery. Finally, the data were sorted and analyzed, and statistical analysis was performed using SPSS software. 

纳入标准：

（1）年龄：40-80岁；（2）择期行颈动脉内膜剥脱术；（3）签署知情同意书。

Inclusion criteria

(1) Age: 40-80 years; (2) Elective carotid endarterectomy; (3) Signed informed consent.

排除标准：

（1） ASA分级IV-VI；（2）肾功能衰竭；（3）严重心律失常；（4）心肌梗死、心力衰竭；（5）无精神障碍和严重视听障碍；（6）可自主完成术前认知功能测试，术前MMSE（Mini-Mental State Examination，简易精神状态量表）得分≥23分。

Exclusion criteria：

(1) ASA grade IV-VI; (2) renal failure; (3) severe arrhythmia; (4) myocardial infarction, heart failure; (5) no mental disorder and severe visual and auditory impairment; (6) able to complete the preoperative cognitive function test independently, and the preoperative MMSE (Mini-Mental State Examination) score is >=23 points.

研究实施时间：

Study execute time：

从 From 2025-03-01 00:00:00至 To 2026-03-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-03-03 00:00:00 至 To 2026-02-28 00:00:00

干预措施：

Interventions：

组别：

去氧肾上腺素组

样本量：

 48

Group：

Phenylephrine group

Sample size：

干预措施：

全身麻醉平稳后，经静脉泵注去氧肾上腺素并将血压维持在基线水平；当颈动脉被钳夹后调节去氧肾上腺素的浓度或给药速度，将血压维持在高于基线20%的水平；颈动脉开放时停止泵注。其余操作同常规全身麻醉。

干预措施代码：

Intervention：

After general anesthesia is stable, phenylephrine is infused intravenously and blood pressure is maintained at the baseline level; when the carotid artery is clamped, the concentration or administration rate of phenylephrine is adjusted to maintain blood pressure 20% higher than the baseline level; the infusion is stopped when the carotid artery is open.Remaining operation was consistent with routine general anesthesia.

Intervention code：

组别：

去甲肾上腺素组

样本量：

 48

Group：

Norepinephrine group

Sample size：

干预措施：

全身麻醉平稳后，经静脉泵注去甲肾上腺素并将血压维持在基线水平；当颈动脉被钳夹后调节去甲肾上腺素的浓度或给药速度，将血压维持在高于基线20%的水平；颈动脉开放时停止泵注。其余操作同常规全身麻醉。

干预措施代码：

Intervention：

After general anesthesia is stable, norepinephrine is infused intravenously and blood pressure is maintained at the baseline level; when the carotid artery is clamped, the concentration or administration rate of norepinephrine is adjusted to maintain blood pressure 20% higher than the baseline level; the infusion is stopped when the carotid artery is open.Remaining operation was consistent with routine general anesthesia.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 青海 

市(区县)：

 西宁 

Country：

China

Province：

Qinghai

City：

Xining

单位(医院)：

 青海大学附属医院 

单位级别：

 三甲 

Institution
hospital：

The Affiliated Hospital of Qinghai University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

局部脑氧饱和度

指标类型：

主要指标

Outcome：

Regional cerebral oxygenation

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

升压药达到目标血压的成功率

指标类型：

次要指标

Outcome：

Success rate of vasopressors in achieving target blood pressure

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

苏醒质量

指标类型：

次要指标

Outcome：

Wake-up quality

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后谵妄发生率

指标类型：

次要指标

Outcome：

Postoperative delirium

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后简易精神状态检查(MMSE)评分

指标类型：

次要指标

Outcome：

Postoperative Mini-Mental State Examination (MMSE) score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术中、术后并发症发生率

指标类型：

次要指标

Outcome：

Incidence of intraoperative and postoperative complications

Type：

Secondary indicator

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：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 40 岁 years
最大 Max age 80 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）：

计算机生成的随机化数字表

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

A computer-generated randomized digital table

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：

双盲，对受试者和研究者均设盲。

Blinding：

Double blind, both subjects and researchers are blinded.

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）：

论文形式发表

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

published with article

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 运用医院数据系统采集需要的数据并记录于excel电子表中

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

Case Record Form, CRF Use the hospital data system to collect the required data and record it in excel spreadsheet.

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：

  2025-02-25 16:50:24