ChiCTR2500114862 版本V1.0 版本创建时间2025/12/18 11:05:49 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：

 ChiCTR2500114862 

最近更新日期：

Date of Last Refreshed on：

 2025-12-18 11:05:45 

注册时间：

Date of Registration：

 2025-12-18 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

病人状态指数指导复杂内镜治疗精准麻醉策略的安全性研究

Public title：

Patient status index to guide the safety of precision anesthesia strategies for complex endoscopic treatment

注册题目简写：

English Acronym：

研究课题的正式科学名称：

病人状态指数指导复杂内镜治疗精准麻醉策略的安全性研究

Scientific title：

Patient status index to guide the safety of precision anesthesia strategies for complex endoscopic treatment

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：

胡海姣 

研究负责人：

刁玉刚 

Applicant：

Hu Haijiao 

Study leader：

Diao Yugang 

申请注册联系人电话：

Applicant telephone：

 +86 187 4240 1562

研究负责人电话：

Study leader's
telephone：

+86 153 0988 1160

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：

 1223981801@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 1223981801@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：

中国辽宁省沈阳市沈河区文化路83号

研究负责人通讯地址：

中国辽宁省沈阳市沈河区文化路83号

Applicant address：

83 Wenhua Road, Shenhe District, Shenyang, Liaoning, China

Study leader's address：

83 Wenhua Road, Shenhe District, Shenyang, Liaoning, China

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：

中国人民解放军北部战区总医院

Applicant's institution：

General Hospital of the Northern Theater of the Chinese People's Liberation Army

研究负责人所在单位：

中国人民解放军北部战区总医院

Affiliation of the Leader：

General Hospital of the Northern Theater of the Chinese People's Liberation Army

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：

 伦审Y(2025)150号

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：

中国人民解放军北部战区总医院伦理委员会

Name of the ethic committee：

Ethics Committee of General Hospital of Northern Theater Command of PLA

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-04-17 00:00:00

伦理委员会联系人：

赵海涛

Contact Name of the ethic committee：

Zhao Haitao

伦理委员会联系地址：

中国辽宁省沈阳市沈河区文化路83号

Contact Address of the ethic committee：

83 Wenhua Road, Shenhe District, Shenyang, Liaoning, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 133 0988 9270

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 szec2005@163.com

研究实施负责（组长）单位：

中国人民解放军北部战区总医院

Primary sponsor：

General Hospital of the Northern Theater of the Chinese People's Liberation Army

研究实施负责（组长）单位地址：

中国辽宁省沈阳市沈河区文化路83号

Primary sponsor's address：

83 Wenhua Road, Shenhe District, Shenyang, Liaoning, 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)：

辽宁

市(区县)：

沈阳

Country：

China

Province：

Liaoning

City：

Shenyang

单位(医院)：

中国人民解放军北部战区总医院

具体地址：

中国辽宁省沈阳市沈河区文化路83号

Institution
hospital：

General Hospital of the Northern Theater of the Chinese People's Liberation Army

Address：

83 Wenhua Road, Shenhe District, Shenyang, Liaoning, China

经费或物资来源：

中国人民解放军北部战区总医院自主科研项目（No. ZZKY2024030）

Source(s) of funding：

Independent scientific research project of General Hospital of Northern Theater Command of the Chinese People's Liberation Army (No. ZZKY2024030)

研究疾病：

复杂内镜治疗  

Target disease：

Complex endoscopic therapy

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：

本研究拟采用随机对照试验，探讨病人状态指数（PSi）监测下不同药物镇静方案与行无痛复杂内镜诊疗患者术中镇静相关不良事件发生率的相关性，为复杂内镜诊疗中镇静监测与镇静药物最佳组合选择提供高质量临床证据。  

Objectives of Study：

This study intends to use a randomized controlled trial to explore the correlation between different drug sedation regimens under the monitoring of patient status index (PSi) and the incidence of adverse events related to sedation in patients undergoing painless and complex endoscopic diagnosis and treatment, and provide high-quality clinical evidence for the best combination of sedation monitoring and sedation drugs in complex endoscopic diagnosis and treatment.

药物成份或治疗方案详述：

术前用药方案为麻醉诱导阿芬太尼6ug/kg+丙泊酚2mg/kg。采用丙泊酚TCI注射系统完成静脉镇静，初始血浆靶浓度均设为2μg/mL，根据镇静深度监测方法调整丙泊酚靶浓度，每次调整幅度均为0.2μg/mL。阿芬太尼维持剂量均为0.5μg/kg/min。 实验组采用PSi指数监测指导下的丙泊酚TCI镇静，镇静目标为PSi值35-50，当PSi值低于35时，需降低丙泊酚TCI靶浓度，当PSi值高于50时，需升高丙泊酚TCI靶浓度。 对照组采用MOAA/S评分指导下的丙泊酚TCI镇静，镇静目标为MOAA/S评分2分，若评分＞2分，需升高丙泊酚TCI靶浓度，若评分＜2分，需降低丙泊酚TCI靶浓度。 观察并记录入室（T0）、给药后2min（T1）、置入内镜时（T2）、手术结束时（T3）、患者苏醒时（T4）的平均动脉压（MAP）、心率（HR）、血氧饱和度（SPO2）、PSi值；并记录术中不良事件包括：高血压、心动过缓、低氧血症、呼吸抑制、注射痛、呃逆；记录血管活性药物使用次数和剂量、记录术中气道干预次数。 

Description for medicine or protocol of treatment in detail：

The preoperative medication regimen is anesthesia inducing afentanil 6ug/kg + propofol 2mg/kg. Intravenous sedation was accomplished by using propofol TCI injection system, and the initial plasma target concentration was set to 2μg/mL. The propofol target concentration was adjusted according to the sedation depth monitoring method, and the adjustment amplitude was 0.2μg/mL for each adjustment. The maintenance dose of afentanil was 0.5 μg/kg/min. The experimental group used propofol TCI sedation under the guidance of PSi index monitoring, and the sedation target was PSi value 35-50. When the PSi value was less than 35, the propofol TCI target concentration should be reduced. When the PSi value was higher than 50, the propofol TCI target concentration should be increased. The control group used propofol TCI sedation under the guidance of MOAA/S score, and the sedation target was 2 points. If the score was >2 points, the concentration of propofol TCI target should be increased. If the score was <2 points, the concentration of propofol TCI target should be reduced. The mean arterial pressure (MAP), heart rate (HR), blood oxygen saturation (SPO2), and PSi values ??were observed and recorded intraoperative adverse events including: hypertension, bradycardia, hypoxemia, respiratory depression, injection pain, and hiccups; the number of vasoactive drugs used and dosages, and the number of intraoperative airway interventions were recorded.  

纳入标准：

1.择期行无痛复杂内镜诊疗的患者，复杂内镜诊疗，ERCP或ESD手术，是指通过内镜实施的消化道深部病变微创介入技术，解剖操作复杂，技术要求精细，出血、穿孔、感染等并发症风险高于常规内镜操作； 2.ASA分级I-III级； 3.体重指数（BMI）18-30 kg/m^2； 4.麻醉方式为静脉麻醉； 5.愿意签署知情同意书并严格遵守临床研究方案。

Inclusion criteria

1. Patients scheduled for elective painless complex endoscopic procedures, such as ERCP or ESD, refer to minimally invasive interventional techniques performed via endoscopy for deep-seated lesions of the gastrointestinal tract, involving complex anatomical manipulation and requiring high technical precision; these procedures carry a higher risk of complications—including bleeding, perforation, and infection—compared to conventional endoscopic procedures; 2. ASA physical status classification I–III; 3. Body mass index (BMI) of 18–30 kg/m2; 4. Anesthesia method: intravenous anesthesia; 5. Willingness to provide informed consent and strictly adhere to the clinical study protocol.

排除标准：

排除标准： 1.循环系统疾病者（心力衰竭、心绞痛、心肌梗死、心律失常）； 2.未控制的高血压（收缩压>=160 mmHg或舒张压>=100 mmHg）或低血压（收缩压<=90 mmHg或舒张压<=60 mmHg）； 3.呼吸系统疾病者（急性呼吸道感染、哮喘发作期、慢性阻塞性肺疾病） 4.Mallampati评分为3或4分； 5.预计操作时间长且复杂（＞2h）的手术； 6.肝功能不全：Child-Pugh评级C级以上； 7.肾功能不全：肾小球滤过率<30 mL/ min或肌酐>2.5 mg/dL； 8.贫血或血小板减少症（血红蛋白< 90 g/L，血小板计数<80×10^9 /L）； 9.改良Allen试验阴性者； 10.实验药物过敏者； 11.长期酗酒或使用精神药物、止痛药者； 12.既往有麻醉镇静意外史和麻醉镇静禁忌症者； 13.近三个月参加过其他药物临床试验者。

Exclusion criteria：

Exclusion criteria: 1 People with circulatory system diseases (heart failure, angina, myocardial infarction, arrhythmia); 2. Uncontrolled hypertension (systolic blood pressure>=160 mmHg or diastolic blood pressure >=100 mmHg) or hypotension (systolic blood pressure <=90 mmHg or diastolic blood pressure <=60 mmHg); 3. People with respiratory diseases (acute respiratory infection, asthma attack, chronic obstructive pulmonary disease) 4.Mallampati score is 3 or 4 points; 5. Surgery with long and complex (>2h) expected operation time; 6. Liver insufficiency: Child-Pugh rating C or above; 7. Renal insufficiency: glomerular filtration rate <30 mL/min or creatinine>2.5 mg/dL; 8. Anemia or thrombocytopenia (hemoglobin < 90 g/L, platelet count < 80 × 10^9 /L); 9. Those who have negative modified Allen test; 10. People with allergic to experimental drugs; 11. People who have been drinking for a long time or use psychotropic drugs and painkillers; 12. Those with previous history of anesthesia and sedation accidents and contraindications to anesthesia and sedation; 13. Those who have participated in clinical trials of other drugs in the past three months.

研究实施时间：

Study execute time：

从 From 2025-06-01 00:00:00至 To 2026-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-01 00:00:00 至 To 2026-04-30 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 380

Group：

Control group

Sample size：

干预措施：

麻醉诱导：阿芬太尼6ug/kg+丙泊酚2mg/kg进行麻醉诱导。采用丙泊酚TCI注射系统完成静脉镇静，初始血浆靶浓度均设为2μg/mL，根据镇静深度检测调整丙泊酚靶浓度，每次调整幅度均为0.2μg/mL。阿芬太尼维持剂量均为0.5μg/kg/min。对照组采用脑电双频指数（BIS）指导下丙泊酚TCI镇静，镇静目标为BIS值40-60，若BIS＞60，需升高丙泊酚TCI靶浓度，若BIS＜40，需降低丙泊酚TCI靶浓度。

干预措施代码：

Intervention：

Anesthesia was induced with alfentanil 6ug/kg and propofol 2mg/kg. Propofol TCI injection system was used to complete intravenous sedation. The initial target plasma concentration of propofol was set at 2μg/mL, and the target concentration of propofol was adjusted according to the depth of sedation, and the range of each adjustment was 0.2μg/mL. The maintenance dose of alfentanil was 0.5μg/kg/min. The control group was sedation with propofol TCI under the guidance of bispectral index (BIS), and the sedation target was 40-60. If BIS > 60, the target concentration of propofol TCI should be increased, and if BIS < 40, the target concentration of propofol TCI should be decreased.

Intervention code：

组别：

试验组

样本量：

 380

Group：

Trial group

Sample size：

干预措施：

麻醉诱导：阿芬太尼6ug/kg+丙泊酚2mg/kg进行麻醉诱导。采用丙泊酚TCI注射系统完成静脉镇静，初始血浆靶浓度均设为2μg/mL，根据镇静深度检测调整丙泊酚靶浓度，每次调整幅度均为0.2μg/mL。阿芬太尼维持剂量均为0.5μg/kg/min。实验组采用PSi指数监测指导下丙泊酚TCI镇静，镇静目标为PSi值35-50，当PSi值低于35时，需降低丙泊酚TCI靶浓度，当PSi值高于50时，需升高丙泊酚TCI靶浓度。

干预措施代码：

Intervention：

Anesthesia was induced with alfentanil 6ug/kg and propofol 2mg/kg. Propofol TCI injection system was used to complete intravenous sedation. The initial target plasma concentration of propofol was set at 2μg/mL, and the target concentration of propofol was adjusted according to the depth of sedation, and the range of each adjustment was 0.2μg/mL. The maintenance dose of alfentanil was 0.5μg/kg/min. The experimental group received propofol TCI sedation under the guidance of PSi index monitoring, and the sedation target was the PSi value of 35-50. When the PSi value was lower than 35, the target concentration of propofol TCI should be reduced, and when the PSi value was higher than 50, the target concentration of propofol TCI should be increased.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 辽宁 

市(区县)：

  

Country：

China

Province：

Liaoning

City：

单位(医院)：

 中国人民解放军北部战区总医院 

单位级别：

 三甲 

Institution
hospital：

General Hospital of the Northern Theater of the Chinese People's Liberation Army

Level of the institution：

Tertiary, Tertiary A

测量指标：

Outcomes：

指标中文名：

镇静相关不良事件发生率 [包括：1.持续任何时间的低氧血症（SpO2＜90％）； 2.需要使用气道干预（包括使用鼻咽通气道、口咽通气道、提拉下颌、球囊面罩通气和气管插管）; 3.低血压：收缩压降低超过术前基础值20%或使用血管活性药维持血压; 4.心律失常（持续任何时间的心率＜50次/分，或心率＞120次/分）; 5.与镇静不佳相关的操作中断或终止）]

指标类型：

主要指标

Outcome：

Incidence of sedation-related adverse events [including: 1. Hypoxemia (SpO2 < 90%) of any duration; 2. Need for airway intervention (including use of nasopharyngeal airway, oropharyngeal airway, jaw lifting, bag-mask ventilation, and endotracheal intubation); 3. Hypotension: Reduction in systolic blood pressure by more than 20% of preoperative baseline or use of vasoactive agents to maintain blood pressure; 4. arrhythmia (heart rate < 50 beats per minute for any duration, or heart rate > 120 bea

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

各组麻醉期间用药情况，观察并记录入室（T0）、给药后2min（T1）、置入内镜时（T2）、手术结束时（T3）、苏醒时（T4）的平均动脉压（MAP）、心率（HR）、血氧饱和度（SPO2）

指标类型：

次要指标

Outcome：

The mean arterial pressure (MAP), heart rate (HR), and blood oxygen saturation (SPO2) were observed and recorded at the time of entering the room (T0), 2min after administration (T1), at the time of endoscope insertion (T2), at the end of operation (T3), and at the time of awakening (T4).

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

患者与内镜医生满意度评分

指标类型：

次要指标

Outcome：

Satisfaction score of patients and endoscopists

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

内镜操作时间

指标类型：

次要指标

Outcome：

Endoscopic procedure time (time from entry of the endoscope into the oral cavity to exit the oral cavity)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

镇静恢复时间（从内镜退出口腔至患者恢复至Aldrete评分=10分的时间）

指标类型：

次要指标

Outcome：

Time to recovery of sedation (time from exit of the endoscope into the mouth to patient's recovery to Aldrete score =10)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

内镜操作相关的不良事件（如意外出血、穿孔）

指标类型：

次要指标

Outcome：

Adverse events related to endoscopic procedures (e.g., unexpected bleeding, perforation)

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：

No

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：

正在进行

Recruiting

年龄范围：

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

根据拟定的纳入和排除标准筛选受试者，采用SPSS软件生成随机数字的方法分为T丙泊酚组（A组）、P丙泊酚组（B组）。

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

Subjects were screened according to the proposed inclusion and exclusion criteria, and random numbers were generated by SPSS software: T propofol group (group A), P propofol group (group B), P cyclopolyol group (group C) and P remazolam group (group D).

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：

未提及

Blinding：

Not stated

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）：

http://www.medresman.org.cn/；数据共享时间预计为研究结束后6个月内（注：仅为预计声明，实际实施由研究者最终决定）

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

http://www.medresman.org.cn/; Data sharing was expected to occur within 6 months of the end of the study (Note: This is only an estimated statement. The actual implementation is ultimately determined by the researcher).

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：

数据收集使用病历记录表，数据管理使用电子采集和管理系统（ResMan）

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

Medical record form was used for data collection and ResMan was used for data management.

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：

  2025-12-18 11:05:45