ChiCTR2600122335 版本V1.0 版本创建时间2026/04/13 02:03:37 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：

 ChiCTR2600122335 

最近更新日期：

Date of Last Refreshed on：

 2026-04-13 02:03:31 

注册时间：

Date of Registration：

 2026-04-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于氨磺必利预防高危腹腔镜术后恶心呕吐：经皮穴位电刺激对比药物联合方案的非劣效性随机对照研究

Public title：

Prevention of Postoperative Nausea and Vomiting after High-Risk Laparoscopic Surgery with Amisulpride: A Non-Inferiority Randomized Controlled Study Comparing Percutaneous Acupoint Electrical Stimulation with Drug Combination Therapy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于氨磺必利预防高危腹腔镜术后恶心呕吐：经皮穴位电刺激对比药物联合方案的非劣效性随机对照研究

Scientific title：

Prevention of Postoperative Nausea and Vomiting after High-Risk Laparoscopic Surgery with Amisulpride: A Non-Inferiority Randomized Controlled Study Comparing Percutaneous Acupoint Electrical Stimulation with Drug Combination Therapy

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：

胡登云 

研究负责人：

王昕 

Applicant：

Dengyun Hu 

Study leader：

Xin Wang 

申请注册联系人电话：

Applicant telephone：

 +86 551 6296 5375

研究负责人电话：

Study leader's
telephone：

+86 551 6296 5375

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：

 1677670092@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 anaesthes@126.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：

安徽省合肥市瑶海区铜陵路街道长江东路574号

研究负责人通讯地址：

安徽省合肥市瑶海区铜陵路街道长江东路574号

Applicant address：

No. 574, East Changjiang Road, Tongling Road Sub-district, Yaohai District, Hefei City, Anhui Province

Study leader's address：

No. 574, East Changjiang Road, Tongling Road Sub-district, Yaohai District, Hefei City, Anhui 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：

合肥市第二人民医院

Applicant's institution：

Hefei Second People's Hospital

研究负责人所在单位：

合肥市第二人民医院

Affiliation of the Leader：

Hefei Second People's 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：

 2026-科研-008

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：

合肥市第二人民医院临床试验伦理委员会

Name of the ethic committee：

Clinical Trial Ethics Committee of Hefei Second People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-01-08 00:00:00

伦理委员会联系人：

邹明明

Contact Name of the ethic committee：

Mingming Zou

伦理委员会联系地址：

安徽省合肥市瑶海区铜陵路街道长江东路574号

Contact Address of the ethic committee：

No. 574, East Changjiang Road, Tongling Road Sub-district, Yaohai District, Hefei City, Anhui Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 138 6598 1583

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：

合肥市第二人民医院

Primary sponsor：

Hefei Second People's Hospital

研究实施负责（组长）单位地址：

安徽省合肥市瑶海区铜陵路街道长江东路574号

Primary sponsor's address：

No. 574, East Changjiang Road, Tongling Road Sub-district, Yaohai District, Hefei City, Anhui 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)：

安徽省

市(区县)：

合肥市

Country：

China

Province：

Anhui

City：

Hefei

单位(医院)：

合肥市第二人民医院

具体地址：

安徽省合肥市瑶海区铜陵路街道长江东路574号

Institution
hospital：

Hefei Second People's Hospital

Address：

No. 574, East Changjiang Road, Tongling Road Sub-district, Yaohai District, Hefei City, Anhui Province

经费或物资来源：

合肥市卫生健康科技项目（基金会齐鲁专项）

Source(s) of funding：

Hefei Health Technology Project (Qilu Special Program of the Foundation)

研究疾病：

高危腹腔镜术后恶心呕吐  

Target disease：

Postoperative nausea and vomiting after high-risk laparoscopic 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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究立足于临床未满足的需求，旨在验证一种“靶点互补、药械结合”的创新多模式方案。对于已接受基础预防（氨磺必利）的高危患者，采用非药物的 TEAS 替代传统的药物联合（昂丹司琼+氨磺必利），其预防效果不劣于药物联合方案。本研究将为 PONV 的防治提供一种更具性价比、副作用更少的优化策略，并为非药物疗法在中高危人群中的应用提供高级别循证医学证据。  

Objectives of Study：

This study is based on the unmet clinical needs and aims to verify an innovative multi-modal approach of "target complementation and drug-device combination". For high-risk patients who have already received basic prevention (Amisulpride), the non-drug TEAS was used as a substitute for the traditional drug combination (ondansetron + amantadine), and its preventive effect was not inferior to the drug combination regimen. This study will provide a more cost-effective and less side-effect optimized strategy for the prevention and treatment of PONV, and provide high-level evidence-based medical evidence for the application of non-drug therapy in the middle and high-risk population.

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. 美国麻醉医师协会（ASA）身体状况分级Ⅰ-Ⅲ级； 2. 年龄 18 至 60 周岁，性别不限； 3. 身体质量指数(BMI)在 18.0-30.0kg/m^2 2 之间（包含临界值）； 4. 拟行需全身麻醉的择期腹腔镜手术。 5. 通过 Apfel 简化风险评分，判断为术后恶心呕吐发生的中高危患者（评分>=2）； 6. 能够理解本实验的程序和方法，经过充分的知情同意，并自愿参加并签署知情同意书。

Inclusion criteria

1. American Society of Anesthesiologists (ASA) physical condition classification: Grade I - III; 2. Age 18 to 60 years old, gender not restricted; 3. Body Mass Index (BMI) between 18.0 - 30.0 kg/m^2 (including the critical value); 4. Scheduled for elective laparoscopic surgery requiring general anesthesia; 5. Judged as patients at moderate to high risk of postoperative nausea and vomiting (score >= 2) based on the Apfel simplified risk score; 6. Able to understand the procedures and methods of this experiment, having given full informed consent, and voluntarily participating and signing the informed consent form.

排除标准：

1. 患有严重呼吸系统病史； 2. 中枢神经系统疾病：患有癫痫、帕金森疾病，或其他引起恶心呕吐的中枢神经系统疾病的受试者； 3. 心血管系统疾病：筛选前 6 个月内存在：NYHA 心功能Ⅲ-Ⅳ级、不稳定性心绞痛、急性心肌梗死、或药物控制不佳的高血压（收缩>=160mmHg 或舒张压>=100mmHg）或其他心脏疾病的患者； 4. 消化系统疾病：患有肠梗阻或引起恶心呕吐的其他消化系统疾病的受试者； 5. 有明显的、慢性头晕病史的受试者，术前 24 小时内发生恶心和/或呕吐、术前 3天内使用过止吐药、催吐药、阿片类药物等； 6. 已知对氨磺必利、昂丹司琼或任一辅料或本实验中所使用的任何成分过敏或有特发反应史者； 7. 植入心脏起搏器、复律器或除颤器的患者； 8. 穴位刺激区域存在皮肤问题

Exclusion criteria：

1. Has a history of severe respiratory system diseases; 2. Central nervous system disorders: Subjects with epilepsy, Parkinson's disease, or other central nervous system disorders causing nausea and vomiting; 3. Cardiovascular system disorders: Subjects with NYHA cardiac function grade III-IV within 6 months prior to screening, unstable angina pectoris, acute myocardial infarction, or poorly controlled hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg) or other heart diseases; 4. Digestive system disorders: Subjects with intestinal obstruction or other digestive system disorders causing nausea and vomiting; 5. Subjects with obvious and chronic dizziness history, nausea and/or vomiting within 24 hours before the operation, use of antiemetic drugs, emetic drugs, opioid drugs, etc. within 3 days before the operation; 6. Those who are known to be allergic to amisulpride, ondansetron, or any excipient or any component used in this experiment, or have a history of allergic reaction; 7. Patients with implanted cardiac pacemaker, cardioverter-defibrillator, or defibrillator; 8. Subjects with skin problems in the acupoint stimulation area.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2028-12-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-04-13 00:00:00 至 To 2028-12-01 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 105

Group：

Experimental group

Sample size：

干预措施：

氨磺必利 5mg + 真·经皮穴位电刺激 + 安慰剂注射液

干预措施代码：

Intervention：

Amisulpride 5mg + True Transcutaneous Acupoint Electrical Stimulation + Placebo Injection.

Intervention code：

组别：

阳性对照组

样本量：

 105

Group：

Positive control group

Sample size：

干预措施：

氨磺必利 5mg + 假·TEAS刺激 + 昂丹司琼 4mg

干预措施代码：

Intervention：

Amisulpride 5mg + sham TEAS stimulation + Ondansetron 4mg

Intervention code：

组别：

对照组

样本量：

 105

Group：

Control group

Sample size：

干预措施：

氨磺必利 5mg + 假·TEAS 刺激 + 安慰剂注射液

干预措施代码：

Intervention：

Amisulpride 5mg + sham TEAS stimulation + placebo injection

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 安徽省 

市(区县)：

 合肥市 

Country：

China

Province：

Anhui

City：

Hefei

单位(医院)：

 合肥市第二人民医院 

单位级别：

 三甲 

Institution
hospital：

Hefei Second People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术后 24 小时内出现术后恶心呕吐发生率

指标类型：

主要指标

Outcome：

The incidence of postoperative nausea and vomiting within 24 hours after surgery

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后 48 小时内救援止吐药使用时间和使用率

指标类型：

次要指标

Outcome：

The time and usage rate of antiemetic drugs administered within 48 hours after the surgery

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

视觉模拟量表

指标类型：

次要指标

Outcome：

Visual Analogue Scale

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 18 岁 years
最大 Max age 60 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）：

采用随机数字表法产生随机序列。由一名不参与临床研究的专业统计人员操作，使用SPSS 26.0软件生成随机数字，按照1:1:1的比例将315例纳入研究的患者随机分为三组。

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

A random sequence was generated using the random number table method. This was carried out by a professional statistician who was not involved in the clinical study. The random numbers were generated using SPSS 26.0 software, and the 315 patients included in the study were randomly divided into three groups in a 1:1:1 ratio.

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：

本研究采用计算机生成随机序列进行分组。由一位不参与试验的独立研究员按1:1:1 比例将受试者随机分配至三个组别。分组信息密封于不透光信封中，于手术当日由其他研究人员启封，并根据编号将受试者分配至对应组别。研究药物配制完成后以不透明材料包裹，再送至手术室。分组信息直至数据分析阶段才予以揭盲。所有麻醉操作及术中指标观察、记录与术后随访，均由一位经验丰富的麻醉医师完成。该医师及受试者均对分组与干预措施不知情，确保实现了研究的双盲设计。

Blinding：

In this study, random sequences were generated by a computer for group allocation. An independent researcher, who was not involved in the trial, randomly assigned the subjects to the three groups in a 1:1:1 ratio. The group allocation information was sealed in an opaque envelope and was opened by other researchers on the day of the surgery. The subjects were assigned to the corresponding groups according to the numbers. After the preparation of the study drugs was completed, they were wrapped in opaque materials and sent to the operating room. The group allocation information was not disclosed until the data analysis stage. All anesthesia procedures, intraoperative indicator observations, records, and postoperative follow-ups were carried out by an experienced anesthesiologist. The anesthesiologist and the subjects were unaware of the group allocation and the intervention measures, ensuring the implementation of the double-blind design of 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

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：

所有观测指标均使用预先设计的标准化病例报告表（CRF）进行采集。数据由专人通过“双人独立录入”或“录入后复核”的方式转录至受控的电子数据库，并进行逻辑校验，目标是将录入错误率控制在5%以下。研究结束后，数据库将在最终审核后锁定，所有更改留有审计痕迹，从而保证研究数据的准确性、完整性及可溯源性，为后续统计分析提供坚实基础。

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

All observation indicators were collected using a pre-designed standardized case report form (CRF). The data were transcribed into a controlled electronic database by designated personnel through either "double independent entry" or "entry followed by review" methods, and logical verification was conducted. The goal was to keep the error rate of data entry below 5%. After the completion of the study, the database would be locked after final review, and all changes would leave audit trails, thereby ensuring the accuracy, completeness and traceability of the research data, and providing a solid foundation for subsequent statistical 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：

  2026-04-13 02:03:31