ChiCTR2500105411 版本V1.0 版本创建时间2025/07/03 08:34:08 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：

 ChiCTR2500105411 

最近更新日期：

Date of Last Refreshed on：

 2025-07-03 08:33:47 

注册时间：

Date of Registration：

 2025-07-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

探究全麻联合鞘内注射吗啡复合罗哌卡因用于胸、腹部大手术的效果对比及罗哌卡因最佳剂量

Public title：

Exploring the Comparative Effects of General Anesthesia Combined with Intrathecal Morphine-Ropivacaine Mixture in Major Thoracoabdominal Surgeries and Determining the Optimal Dose of Ropivacaine

注册题目简写：

English Acronym：

研究课题的正式科学名称：

探究全麻联合鞘内注射吗啡复合罗哌卡因用于胸、腹部大手术的效果对比及罗哌卡因最佳剂量

Scientific title：

Exploring the Comparative Effects of General Anesthesia Combined with Intrathecal Morphine-Ropivacaine Mixture in Major Thoracoabdominal Surgeries and Determining the Optimal Dose of Ropivacaine

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：

马雪松 

研究负责人：

马雪松 

Applicant：

Xuesong Ma 

Study leader：

Xuesong Ma 

申请注册联系人电话：

Applicant telephone：

 +86 13613630888

研究负责人电话：

Study leader's
telephone：

+86 13613630888

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：

 mxs13613630888@163.com

研究负责人电子邮件：

Study leader's E-mail：

 mxs13613630888@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：

黑龙江省哈尔滨市南岗区颐园街37号

研究负责人通讯地址：

黑龙江省哈尔滨市南岗区颐园街37号

Applicant address：

No. 37, Yiyuan Street, Nangang District, Harbin, Heilongjiang

Study leader's address：

No. 37, Yiyuan Street, Nangang District, Harbin, Heilongjiang

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：

哈尔滨医科大学附属第四医院

Applicant's institution：

The Fourth Affiliated Hospital of Harbin Medical University

研究负责人所在单位：

哈尔滨医科大学附属第四医院

Affiliation of the Leader：

The Fourth Affiliated Hospital of Harbin Medical University

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：

 2025-伦理审查-103

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：

哈尔滨医科大学附属第四医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Fourth Affiliated Hospital of Harbin Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-07-01 00:00:00

伦理委员会联系人：

王玉珏

Contact Name of the ethic committee：

Wang Yujue

伦理委员会联系地址：

黑龙江省哈尔滨市南岗区颐园街37号

Contact Address of the ethic committee：

No. 37, Yiyuan Street, Nangang District, Harbin, Heilongjiang

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 451 82576558

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 297121751@qq.com

研究实施负责（组长）单位：

哈尔滨医科大学附属第四医院

Primary sponsor：

The Fourth Affiliated Hospital of Harbin Medical University

研究实施负责（组长）单位地址：

黑龙江省哈尔滨市南岗区颐园街37号

Primary sponsor's address：

No. 37, Yiyuan Street, Nangang District, Harbin, Heilongjiang

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

黑龙江

市(区县)：

Country：

China

Province：

Heilongjiang

City：

单位(医院)：

哈尔滨医科大学附属第四医院

具体地址：

黑龙江省哈尔滨市南岗区颐园街37号

Institution
hospital：

The Fourth Affiliated Hospital of Harbin Medical University

Address：

No. 37, Yiyuan Street, Nangang District, Harbin, Heilongjiang

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

术后疼痛  

Target disease：

Postoperative pain

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：

队列研究 

Study design：

Cohort study 

研究目的：

探究全麻联合鞘内注射吗啡复合罗哌卡因用于胸、腹部大手术，对患者麻醉维持及术后镇痛的影响。  

Objectives of Study：

Exploring the effects of general anesthesia combined with intrathecal injection of morphine and ropivacaine on anesthesia maintenance and postoperative analgesia in patients undergoing major thoracic and abdominal surgeries.

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.择期行麻醉下胸、腹部大手术并签署知情同意书；
2.年龄18-75岁，美国麻醉医师分级Ⅰ-Ⅱ级；
3.术前72 h内未服用镇痛、镇静药物或对其过敏者；
4.麻醉时间为2~5 h；
5.愿意配合研究及术后三天内随访；

Inclusion criteria

1.Electively perform major chest and abdominal surgery under anesthesia and sign an informed consent form;
2.Age 18-75 years old, American anesthesiologist classification I-II;
3.Those who have not taken analgesics, sedatives or are allergic to them within 72 hours before surgery;
4.The anesthesia time is 2-5 hours;
5.Willing to cooperate with research and postoperative follow-up;

排除标准：

1.术前无法进行沟通配合，存在昏迷、严重痴呆、严重精神障碍等；
2.合并明显心肝肾功能障碍、不能耐受手术的疾病者；
3.依从性差、有凝血功能障碍、脊柱畸形、穿刺部位感染、难以配合穿刺操作完成治疗者；
4.术中意外发生药物过敏、转行开放式手术；
5.术后三天内无法回访；

Exclusion criteria：

1.Unable to communicate and cooperate before surgery, resulting in coma, severe dementia, severe mental disorders, etc;
2.Patients with obvious liver, liver and kidney dysfunction and intolerance to surgery;
3.Patients with poor compliance, coagulation dysfunction, spinal deformities, infection at the puncture site, and difficulty cooperating with the puncture operation to complete treatment;
4.Unexpected drug allergy during surgery, switch to open surgery;
5.Unable to follow up within three days after surgery;

研究实施时间：

Study execute time：

从 From 2025-06-01 00:00:00至 To 2026-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-07-04 00:00:00 至 To 2026-01-31 00:00:00

干预措施：

Interventions：

组别：

鞘内吗啡+罗哌卡因6mg组（B2组）

样本量：

 30

Group：

Intrathecal morphine+ropivacaine 6mg group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

N/A

Intervention code：

组别：

鞘内吗啡组（A组）

样本量：

 30

Group：

Intrathecal morphine group (Group A)

Sample size：

干预措施：

无

干预措施代码：

Intervention：

N/A

Intervention code：

组别：

鞘内吗啡+罗哌卡因4mg组（B1组）

样本量：

 30

Group：

Intrathecal morphine+ropivacaine 4mg group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

N/A

Intervention code：

组别：

对照组（常规静脉镇痛组）

样本量：

 30

Group：

Control group (conventional intravenous analgesia group)

Sample size：

干预措施：

无

干预措施代码：

Intervention：

N/A

Intervention code：

组别：

鞘内吗啡+罗哌卡因8mg组（B3组）

样本量：

 30

Group：

Intrathecal morphine+ropivacaine 8mg group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

N/A

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 黑龙江 

市(区县)：

  

Country：

China

Province：

Heilongjiang

City：

单位(医院)：

 哈尔滨医科大学附属第四医院 

单位级别：

 三甲 

Institution
hospital：

The Fourth Affiliated Hospital of Harbin Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

毒麻药品相关不良反应发生情况（术后头晕、呼吸抑制、恶心恶吐、尿储留、导尿管相关膀胱不适(CRBD)、皮肤瘙痒、低血压等）

指标类型：

次要指标

Outcome：

Occurrence of toxic and anesthetic drug-related adverse reactions (postoperative dizziness, respiratory depression, nausea and vomiting, urine retention, catheter-related bladder discomfort (CRBD), pruritus, hypotension, etc.)

Type：

Secondary indicator

测量时间点：

术后72小时内

测量方法：

通过术后访视，记录术后72小时内患者不良反应发生情况

Measure time point of outcome：

Within 72 hours after surgery

Measure method：

Record the occurrence of adverse reactions in patients within 72 hours after surgery through postoperative visits

指标中文名：

观察术中瑞芬太尼用量以及术后72小时VAS评分

指标类型：

主要指标

Outcome：

Observation of intraoperative remifentanil dosage and postoperative 72 hour VAS score

Type：

Primary indicator

测量时间点：

术后72小时内

测量方法：

通过术中数据记录瑞芬太尼用量。通过术后访视，记录术后72小时内患者VAS评分

Measure time point of outcome：

Within 72 hours after surgery

Measure method：

Record the dosage of remifentanil through intraoperative data. Record the patient's VAS score within 72 hours after surgery through postoperative visits

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

N/A

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 18 岁 years
最大 Max age 75 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:

不公开/Private

盲法：

无

Blinding：

None

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：

数据管理 本研究采用医研通数据平台进行电子化数据管理，在试验启动之前对参加人员进行相关培训。数据管理方根据病例报告表构建e-CRF。 1 数据记录 1）研究者填写临床试验记录要求：及时、准确、完整、规范、真实； 2）全部病例均按方案规定，认真书写病历和病例报告表，所有项目均需填写，不得空项、漏项（无记录的空格划斜线）。 3）病历及病例报告表作为原始记录，做任何更正时只能划线，旁注修改后数据，说明理由并由参加临床试验的医师和研究者签名并注明日期，不得擦涂、覆盖原始记录。 4）化验单齐全并粘贴在病例报告表上，病例报告表记录的数据要与病历及原始检验报告核对无误。 5）对显著异常或在临床可接受范围以外的数据需加以合适，由参加临床试验的医师做必要的说明。 6）每一位受试者观察疗程结束后，研究者应在3个工作日内将病例报告表及病历交本单位主要研究者审核、签名。 2 数据监察 1）主研单位质控人员在试验过程中要核查研究者是否遵循试验方案，定期去各试验中心检查受试者的知情同意及筛选纳入情况； 2）确认所有病例报告表填写及时、正确，并与原始资料真实、一致；所有错误或遗漏均已改正或注明，经研究者签名并注明日期；每一受试者的剂量改变、治疗变更、合并用药、间发疾病、检查遗漏等均应确认并记录； 3）核实入选受试者的退出须在病例报告表中予以说明；确认所有不良事件均应记录在案，严重不良事件在规定时间内作出报告并记录在案；核实试验用药品是否按照有关规定进行供应、储藏、分发、回收，并做相应的记录。 3 数据保存 1）建立数据库：根据病例报告表的项目采用医研通数据平台建立相应录入程序，并设定录入时的逻辑审查限定条件，对数据库进行试运行，建立本试验专用的数据库系统。 2）录入前再次核查：对病例报告表进一步检查。已经审核声明签字的病例报告表交数据管理员，数据管理员对日期、入组标准、排除标准、脱落、缺失值等进行检查，如有疑问，可填写疑问表返回检察员，由研究者对疑问表中的问题进行书面解答并签名，交回数据管理员，疑问表应妥善保管。 3）数据录入：e-CRF数据来源于原始记录，由研究者根据e-CRF填写说明，将受试者研究数据及时录入医研通数据平台中，保证数据的真实、准确、完整、及时，并需确保与受试者原始病历数据核对一质性。 4）数据审核：采用计算机软件中的核查功能进行逻辑检查与自动比较，查对与病例报告表不一致的结果值，然后逐项与原始病例报告表核对，予以更正。再进行病例报告表和数据库中的数据与病例报告表中的结果一致。 5）数据锁定：由主要研究者、申办者，统计分析人员和数据管理人员共同签署数据锁定记录后，数据管理员进行数据库锁定。

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

Data Management In this study, the medical research and development data platform was used for electronic data management. The data management party builds an e-CRF based on the case report form and creates an account based on the information provided by the researcher. 1. Data Recording 1) The researcher fills in the clinical test record requirements: timely, accurate, complete, standardized, and true; 2) All cases are written according to the regulations, and the medical records and case report forms are carefully written. All items need to be filled out, and no empty items or missing items (with no recorded spaces); 3) The medical record and case report form are used as the original records. Any corrections can only be crossed, and the revised data should be inserted. The reasons are indicated and signed and dated by the doctors and researchers participating in the clinical trial. recording; 4) The test list is complete and pasted on the case report form, and the data recorded in the case report form should be checked against the medical record and the original test report; 5) Appropriate abnormality or data outside the clinically acceptable range should be appropriate, and the necessary explanation should be given by the physician participating in the clinical trial; 6) After the end of the observation course, the investigator shall review and sign the case report form and the medical record to the main investigator of the unit within 3 working days; 2. Data monitoring 1) The quality control personnel of the main research unit should check whether the researcher follows the test plan during the test, and regularly go to each test center to check the subject's informed consent and screening and inclusion; 2) Confirm that all case report forms are filled in correctly and correctly, and are true and consistent with the original materials; all errors or omissions have been corrected or indicated, signed and dated by the investigator; dose change and treatment of each subject Changes, combined medications, intermittent illnesses, and omissions should be confirmed and recorded; 3) Verification of the withdrawal of the selected subjects shall be stated in the case report form; confirmation that all adverse events shall be recorded, serious adverse events shall be reported and recorded within the specified time; verification of whether the test drugs are in accordance with relevant regulations Supply, store, distribute, recycle, and record accordingly. 3 data saving 1) Establish database: According to the project of the case report form, use the medical research data platform to establish the corresponding entry procedure, and set the logical review qualification conditions at the time of entry, test run the database, and establish a database system dedicated to the test; 2) Check again before entering: further check the case report form. The case report form signed by the audited statement is submitted to the data administrator. The data manager checks the date, the entry criteria, the exclusion criteria, the dropout, the missing value, etc. If in doubt, you can fill in the question form and return to the inspector. The questions in the question form are answered in writing and signed, and returned to the data administrator. The question form should be kept in a safe place; 3) Data entry: The e-CRF data is derived from the original record. The researcher fills in the e-CRF instructions and records the subject research data into the medical research data platform in time to ensure the data is true, accurate, complete and timely. It is also necessary to ensure that the original medical record data of the subject is checked for qualitative; 4) Data audit: Use the verification function in the computer software to perform logical check and automatic comparison, check the result value that is inconsistent with the case report form, and then check the original case report form item by item and correct it. The data in the case report form and the database are consistent with the results in the case report form; 5) Data lock: After the data lock record is signed by the main researcher, sponsor, statistical analyst and data management personnel, the data administrator performs database lock.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-07-03 08:33:47