ChiCTR2600120365 版本V1.0 版本创建时间2026/03/12 17:51:03 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：

 ChiCTR2600120365 

最近更新日期：

Date of Last Refreshed on：

 2026-03-12 17:50:35 

注册时间：

Date of Registration：

 2026-03-12 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

环泊酚与丙泊酚对胸腔镜手术患者脑氧饱和度的影啊：一项随机对照研究

Public title：

Comparison of the effects of ciprofol and propofol on cerebral oxygen saturation in patients undergoing thoracoscopic surgery: a randomized controlled study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

环泊酚与丙泊酚对胸腔镜手术患者脑氧饱和度的影啊：一项随机对照研究

Scientific title：

Comparison of the effects of ciprofol and propofol on cerebral oxygen saturation in patients undergoing thoracoscopic surgery: a randomized controlled study

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：

陈品秀 

研究负责人：

林菁艳 

Applicant：

Pinxiu Chen 

Study leader：

Jingyan Lin 

申请注册联系人电话：

Applicant telephone：

 +86 173 8095 6963

研究负责人电话：

Study leader's
telephone：

+86 159 8377 1119

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：

 1553015117@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 linjingyan@nsmc.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：

四川省南充市顺庆区茂源南路1号

研究负责人通讯地址：

四川省南充市顺庆区茂源南路1号

Applicant address：

No. 1, Maoyuan South Road, Shunqing District, Nanchong City, Sichuan Province

Study leader's address：

No. 1, Maoyuan South Road, Shunqing District, Nanchong City, Sichuan Province

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：

川北医学院附属医院

Applicant's institution：

Affiliated Hospital of North Sichuan Medical College

研究负责人所在单位：

川北医学院附属医院

Affiliation of the Leader：

Affiliated Hospital of North Sichuan Medical College

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：

 2025ER776-1

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：

川北医学院附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee Of Affliated Hospital of North Sichuan Medical College

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-01-21 00:00:00

伦理委员会联系人：

侯令密

Contact Name of the ethic committee：

Hou Lingmi

伦理委员会联系地址：

四川省南充市顺庆区茂源南路1号

Contact Address of the ethic committee：

No. 1, Maoyuan South Road, Shunqing District, Nanchong City, Sichuan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 138 9079 8808

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：

川北医学院附属医院

Primary sponsor：

Affiliated Hospital of North Sichuan Medical College

研究实施负责（组长）单位地址：

四川省南充市顺庆区茂源南路1号

Primary sponsor's address：

No. 1, Maoyuan South Road, Shunqing District, Nanchong City, Sichuan 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)：

四川省

市(区县)：

Country：

China

Province：

Sichuan

City：

单位(医院)：

川北医学院附属医院

具体地址：

四川省南充市顺庆区茂源南路1号

Institution
hospital：

Affiliated Hospital of North Sichuan Medical College

Address：

No. 1, Maoyuan South Road, Shunqing District, Nanchong City, Sichuan Province

经费或物资来源：

川北医学院附属医院

Source(s) of funding：

Affiliated Hospital of North Sichuan Medical College

研究疾病：

胸腔镜手术相关围术期脑氧管理相关病症  

Target disease：

Perioperative cerebral oxygen management-related disorders associated with thoracoscopic surgery

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：

 上市后药物 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

主要目的：比较环泊酚与丙泊酚用于胸腔镜手术患者麻醉诱导后至开胸前，脑氧饱和度（rSO?）较基线差异的曲线下面积（AUC），评估两种药物在药物效应叠加体位操作的协同场景下，对脑氧稳定性的整体影响.次要目的：1. 对比两组患者术后认知功能暂时性减退发生情况；2. 评估两种药物对麻醉诱导后至开胸前血流动力学的影响；3. 比较两组麻醉诱导相关指标及血管活性药物使用剂量；4. 记录并对比两组诱导期不良反应发生情况。  

Objectives of Study：

Primary Objective:To compare the area under the curve (AUC) of the difference in cerebral oxygen saturation (rSO?) from the baseline between ciprofol and propofol in patients undergoing thoracoscopic surgery from anesthesia induction to before thoracotomy, and to evaluate the overall effect of the two drugs on cerebral oxygen stability in the synergistic scenario of drug effect superimposed with position operation. Secondary Objectives:1. To compare the incidence of transient postoperative cognitive impairment between the two groups; 2. To evaluate the effects of the two drugs on hemodynamics from anesthesia induction to before thoracotomy; 3. To compare the anesthesia induction-related indicators and the dosage of vasoactive drugs between the two groups; 4. To record and compare the incidence of adverse reactions during induction in the two groups.

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，性别不限； 2. 拟行择期胸腔镜肺叶/楔形/肺段切除术； 3. ASA体力状态分级I-III级； 4. BMI 18.0-30.0kg/m2； 5. 术前双侧rSO?≥65%（爱琴FNGINMED EGOS-600A监测）； 6. 术前认知正常（MMSE评分：文盲≥17分、小学≥20分、中学及以上≥24分）； 7. 患者及家属签署书面知情同意书。

Inclusion criteria

1. Aged 18-65 years, regardless of gender; 2. Scheduled for elective thoracoscopic lobectomy/wedge resection/segmentectomy; 3. ASA physical status classification Grade I-III; 4. BMI 18.0-30.0kg/m2; 5. Preoperative bilateral rSO? >=65% (monitored by FNGINMED EGOS-600A); 6. Normal preoperative cognitive function (MMSE score: illiterate >=17 points, primary school education >=20 points, middle school education and above >=24 points); 7. Written informed consent signed by patients and their family.

排除标准：

1. 有脑血管疾病史（脑卒中、短暂性脑缺血发作）或严重颅内病变； 2. 严重心肺功能障碍（NYHA心功能III-Ⅳ级、FVC<50%预计值）； 3. 肝肾功能衰竭（肌酐>176μmol/L、血尿素氮>7.1mmol/L、Child-Pugh B级及以上）； 4. 对环泊酚、丙泊酚、七氟醚或顺阿曲库溴铵过敏； 5. 术前1周内使用镇静催眠药、阿片类药物或抗精神病药物； 6. 前额皮肤损伤无法粘贴rSO?探头； 7. 妊娠、哺乳期女性或计划3个月内妊娠者。

Exclusion criteria：

1. History of cerebrovascular disease (stroke, transient ischemic attack) or severe intracranial lesions; 2. Severe cardiopulmonary dysfunction (NYHA cardiac function Grade III-IV, FVC<50% predicted value); 3. Hepatic and renal failure (serum creatinine >176μmol/L, blood urea nitrogen >7.1mmol/L, Child-Pugh Grade B and above); 4. Hypersensitivity to ciprofol, propofol, sevoflurane or cisatracurium besylate; 5. Use of sedative-hypnotics, opioids or antipsychotics within 1 week before surgery; 6. Forehead skin injury that cannot attach rSO? probe; 7. Pregnant or lactating women, or those planning to become pregnant within 3 months.

研究实施时间：

Study execute time：

从 From 2026-01-22 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-03-01 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

环泊酚组

样本量：

 39

Group：

Ciprofol Group

Sample size：

干预措施：

1. 麻醉诱导：静脉推注环泊酚0.4mg/kg（推注>60s），同步推注舒芬太尼0.3μg/kg、顺阿曲库溴铵0.15mg/kg（推注>20s），睫毛反射消失为意识丧失，未达标则按规范追加剂量；待BIS≤60、肌松达标后行双腔气管插管（纤维支气管镜确认位置）。2. 麻醉维持：插管后环泊酚持续泵注至开胸时，调整输注速率维持麻醉深度；开胸后采用七氟醚吸入+瑞芬太尼0.1-0.2μg/(kg·min)静脉泵注，顺阿曲库溴铵按需追加至手术结束。3. 体位操作：麻醉诱导后至开胸前完成仰卧位→侧卧位转换，纳入9个固定时间点监测。

干预措施代码：

Intervention：

1. Anesthesia induction: Intravenous bolus of ciprofol 0.4mg/kg (injection >60s), simultaneous bolus of sufentanil 0.3μg/kg and cisatracurium besylate 0.15mg/kg (injection >20s). Loss of consciousness is defined as disappearance of corneal reflex, and additional doses are administered according to specifications if not up to standard. Double-lumen endotracheal intubation (position confirmed by fiberoptic bronchoscopy) is performed when BIS<=60 and muscle relaxation is up to standard. 2. Anesthesia maintenance: Continuous intravenous infusion of ciprofol until thoracotomy after intubation, adjust the infusion rate to maintain anesthesia depth; after thoracotomy, inhalation of sevoflurane combined with intravenous pump infusion of remifentanil 0.1-0.2μg/(kg·min), cisatracurium besylate is added on demand until the end of surgery. 3. Position operation: Conversion from supine to lateral decubitus position is completed from anesthesia induction to before thoracotomy, included in monitoring at 9 fixed time points.

Intervention code：

组别：

丙泊酚组

样本量：

 39

Group：

Propofol Group

Sample size：

干预措施：

1. 麻醉诱导：静脉推注丙泊酚2.0mg/kg（推注>60s），其余诱导用药、给药方式、插管指征及操作同环泊酚组。2. 麻醉维持：插管后丙泊酚持续泵注至开胸时，调整输注速率维持麻醉深度；开胸后麻醉维持方案同环泊酚组。3. 体位操作：体位转换的时间、方式同环泊酚组，纳入相同9个固定时间点监测。

干预措施代码：

Intervention：

1. Anesthesia induction: Intravenous bolus of propofol 2.0mg/kg (injection >60s), the remaining induction drugs, administration methods, intubation indications and operations are the same as the ciprofol group. 2. Anesthesia maintenance: Continuous intravenous infusion of propofol until thoracotomy after intubation, adjust the infusion rate to maintain anesthesia depth; the anesthesia maintenance protocol after thoracotomy is the same as the ciprofol group. 3. Position operation: The time and method of position conversion are the same as the ciprofol group, included in monitoring at the same 9 fixed time points.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川省 

市(区县)：

  

Country：

China

Province：

Sichuan

City：

单位(医院)：

 川北医学院附属医院 

单位级别：

 三甲 

Institution
hospital：

Affiliated Hospital of North Sichuan Medical College

Level of the institution：

Teriary A

测量指标：

Outcomes：

指标中文名：

麻醉诱导后至开胸前脑氧饱和度较基线差异的曲线下面积

指标类型：

主要指标

Outcome：

AUC of rSO2 deviation from baseline during induction to thoracotomy

Type：

Primary indicator

测量时间点：

T0-T8（T0麻醉诱导前基线、T1诱导后30s、T2诱导后1.5min、T3插管前1min、T4插管后1min、T5体位改变前1min、T6体位改变后1min、T7体位改变后3min、T8开胸前），基于T0基线计算各时间点差异并拟合曲线

测量方法：

Measure time point of outcome：

From T0 to T8 (T0: Pre-induction baseline, T1: 30s after induction, T2: 1.5min after induction, T3: 1min before intubation, T4: 1min after intubation, T5: 1min before position change, T6: 1min after position change, T7: 3min after position change, T8: before thoracotomy); calculate differences from T0 baseline at each time point and fit the curve

Measure method：

指标中文名：

术后 6 小时、12 小时、24 小时简易精神状态检查量表（MMSE）评分

指标类型：

次要指标

Outcome：

MMSE scores at 6h, 12h, and 24h after surgery

Type：

Secondary indicator

测量时间点：

术前 1 天（基线）、术后 6h、术后 12h、术后 24h

测量方法：

Measure time point of outcome：

1 day before surgery (baseline), 6h after surgery, 12h after surgery, 24h after surgery

Measure method：

指标中文名：

术后认知功能暂时性减退发生率

指标类型：

次要指标

Outcome：

Incidence of postoperative cognitive dysfunction

Type：

Secondary indicator

测量时间点：

术后 6h、术后 12h、术后 24h

测量方法：

Measure time point of outcome：

6h after surgery, 12h after surgery, 24h after surgery

Measure method：

指标中文名：

T0-T8 时间点平均动脉压（MAP）值

指标类型：

次要指标

Outcome：

MAP values at T0-T8 time points

Type：

Secondary indicator

测量时间点：

T0-T8（T0麻醉诱导前基线、T1诱导后30s、T2诱导后1.5min、T3插管前1min、T4插管后1min、T5体位改变前1min、T6体位改变后1min、T7体位改变后3min、T8开胸前）

测量方法：

Measure time point of outcome：

From T0 to T8 (T0: Pre-induction baseline, T1: 30s after induction, T2: 1.5min after induction, T3: 1min before intubation, T4: 1min after intubation, T5: 1min before position change, T6: 1min after position change, T7: 3min after position change, T8: before thoracotomy)

Measure method：

指标中文名：

T0-T8 时间点心率（HR）值

指标类型：

次要指标

Outcome：

HR values at T0-T8 time points

Type：

Secondary indicator

测量时间点：

T0-T8（T0麻醉诱导前基线、T1诱导后30s、T2诱导后1.5min、T3插管前1min、T4插管后1min、T5体位改变前1min、T6体位改变后1min、T7体位改变后3min、T8开胸前）

测量方法：

Measure time point of outcome：

From T0 to T8 (T0: Pre-induction baseline, T1: 30s after induction, T2: 1.5min after induction, T3: 1min before intubation, T4: 1min after intubation, T5: 1min before position change, T6: 1min after position change, T7: 3min after position change, T8: before thoracotomy)

Measure method：

指标中文名：

诱导后至开胸前平均动脉压最大下降值

指标类型：

次要指标

Outcome：

Maximum decrease of MAP during induction to thoracotomy

Type：

Secondary indicator

测量时间点：

T0-T8（T0麻醉诱导前基线、T1-T8同步监测时间点），计算较T0基线的最大下降幅度

测量方法：

Measure time point of outcome：

From T0 to T8 (T0: Pre-induction baseline, T1-T8: Synchronized monitoring time points); calculate the difference between the maximum and minimum HR during this period

Measure method：

指标中文名：

诱导后至开胸前低血压发生率

指标类型：

次要指标

Outcome：

Incidence of hypotension during induction to thoracotomy

Type：

Secondary indicator

测量时间点：

T0-T8（T0麻醉诱导前基线、T1-T8同步监测时间点），记录MAP<65mmHg或较T0基线下降≥30%的发生情况

测量方法：

Measure time point of outcome：

From T0 to T8 (T0: Pre-induction baseline, T1-T8: Synchronized monitoring time points); record the occurrence of MAP<65mmHg or ≥30% decrease compared with T0 baseline

Measure method：

指标中文名：

意识消失时间（睫毛反射消失时间）

指标类型：

次要指标

Outcome：

Time to loss of consciousness

Type：

Secondary indicator

测量时间点：

麻醉诱导药物推注开始至睫毛反射消失

测量方法：

Measure time point of outcome：

From start of induction drug infusion until loss of eyelash reflex

Measure method：

指标中文名：

诱导后至开胸前环泊酚 / 丙泊酚总泵注剂量

指标类型：

次要指标

Outcome：

Total dosage of ciprofol/propofol during induction to thoracotomy

Type：

Secondary indicator

测量时间点：

麻醉诱导后至开胸前

测量方法：

Measure time point of outcome：

from after anesthesia induction to before thoracotomy

Measure method：

指标中文名：

诱导后至开胸前血管活性药物使用剂量

指标类型：

次要指标

Outcome：

Dosage of vasoactive drugs during induction to thoracotomy

Type：

Secondary indicator

测量时间点：

麻醉诱导后至开胸前

测量方法：

Measure time point of outcome：

from after anesthesia induction to before thoracotomy

Measure method：

指标中文名：

麻醉诱导期注射痛发生率

指标类型：

次要指标

Outcome：

Incidence of injection pain during induction

Type：

Secondary indicator

测量时间点：

麻醉诱导药物推注过程中

测量方法：

Measure time point of outcome：

During infusion of induction drug

Measure method：

指标中文名：

麻醉诱导期呛咳发生率

指标类型：

次要指标

Outcome：

Incidence of cough during induction

Type：

Secondary indicator

测量时间点：

麻醉诱导药物推注过程中

测量方法：

Measure time point of outcome：

During infusion of induction drug

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

no

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：

正在进行

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）：

单随机化，用SPSS/R等统计软件生成1:1随机数序列，按78例样本量完成分组，随机数与受试者一一对应分配组别，结果密封保存。

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

Simple randomization; generate a 1:1 random number sequence with SPSS/R for 78 subjects, match random numbers with subjects one by one for group assignment, and seal the results for storage.

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：

受试者不知晓分组及用药信息；因研究药物给药剂量存在明确差异，临床研究人员知晓分组，全程保证受试者盲态。

Blinding：

subjects are unaware of grouping and medication information; clinical researchers are aware of grouping due to obvious differences in study drug dosages, and the blind state of subjects is maintained throughout the study.

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

是Yes

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）：

研究结果发表后6个月内，通过ResMan临床试验公共管理平台（www.medresman.org）共享去标识化的原始数据，包括患者基线资料、T0-T8时间点rSO?/MAP/HR监测数据、MMSE评分、药物使用剂量及不良反应发生情况。共享数据仅提供在线浏览，如需下载需与研究者联系，且所有共享内容已通过伦理委员会批准，不包含任何受试者隐私信息。

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

De-identified individual participant data (IPD), including baseline characteristics, rSO?/MAP/HR monitoring data at T0-T8 time points, MMSE scores, drug dosage and adverse reactions, will be shared via the ResMan platform (www.medresman.org) within 6 months after the publication of study results. The shared data is available for online viewing only; download requests must be directed to the investigators. All data sharing has been approved by the ethics committee and does not contain any identifiable participant information.

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：

由指定人员先进行纸质采集数据，采集后由负责人将数据录入电脑管理系统，以备后期统计分析。

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

The designated personnel first conduct paper collection date, and after the collection, the person in charge records the date in to computer management for later statistital analysis.

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：

  2026-03-12 17:50:35