ChiCTR2600124253 版本V1.0 版本创建时间2026/05/09 11:29:12 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：

 ChiCTR2600124253 

最近更新日期：

Date of Last Refreshed on：

 2026-05-09 11:28:49 

注册时间：

Date of Registration：

 2026-05-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

术中安瑞克芬用于腹部手术术后胃肠功能影响的随机对照试验

Public title：

Randomized controlled trial of intraoperative Anrecofen on postoperative gastrointestinal function in abdominal surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

术中安瑞克芬用于腹部手术术后胃肠功能影响的随机对照试验

Scientific title：

Randomized controlled trial of intraoperative Anrecofen on postoperative gastrointestinal function in abdominal surgery

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：

莫桂熙 

研究负责人：

莫桂熙 

Applicant：

Mo Guixi 

Study leader：

Mo Guixi 

申请注册联系人电话：

Applicant telephone：

 +86 759 238 7429

研究负责人电话：

Study leader's
telephone：

+86 759 238 7429

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：

 mogxi@163.com

研究负责人电子邮件：

Study leader's E-mail：

 mogxi@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：

广东省湛江市霞山区人民大道南57号

研究负责人通讯地址：

广东省湛江市霞山区人民大道南57号

Applicant address：

57 South Renmin Avenue, Xiashan District, Zhanjiang, Guangdong Province

Study leader's address：

57 South Renmin Avenue, Xiashan District, Zhanjiang, Guangdong 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：

广东医科大学附属医院

Applicant's institution：

Guangdong Medical University Affiliated Hospital

研究负责人所在单位：

广东医科大学附属医院

Affiliation of the Leader：

Affiliated Hospital of Guangdong 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：

 PJKT2025-316

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：

广东医科大学附属医院临床科研伦理委员会

Name of the ethic committee：

Ethics Committee for Institutional Review Affiliated Hospitals of Guangdong Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-01-13 00:00:00

伦理委员会联系人：

王健丽

Contact Name of the ethic committee：

Wang Jianli

伦理委员会联系地址：

广东省湛江市霞山区人民大道南57号

Contact Address of the ethic committee：

57 South Renmin Avenue, Xiashan District, Zhanjiang, Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 759 2386971

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 3221452@qq.com

研究实施负责（组长）单位：

广东医科大学附属医院

Primary sponsor：

Affiliated Hospital of Guangdong Medical University

研究实施负责（组长）单位地址：

广东省湛江市霞山区人民大道南57号

Primary sponsor's address：

57 South Renmin Avenue, Xiashan District, Zhanjiang, Guangdong 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)：

广东省

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

广东医科大学附属医院

具体地址：

广东省湛江市霞山区人民大道南57号

Institution
hospital：

Affiliated Hospital of Guangdong Medical University

Address：

57 South Renmin Avenue, Xiashan District, Zhanjiang, Guangdong Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self selected topic (self funded)

研究疾病：

腹部手术（胃肠、肝胆、胰腺等腹部手术）  

Target disease：

gastrointestinal surgery (stomach, intestines, liver, gallbladder, pancreas, etc.)

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：

1.主要研究目的：本研究旨在通过单中心、随机、单盲、对照设计，以接受胃肠、肝胆、胰腺等腹部手术的患者（含老年患者）为研究对象，明确术中及术后使用新型外周 κ 受体镇痛药物安瑞克芬，在保证术后镇痛效果的前提下，对术后胃肠功能恢复（以首次排气时间、首次排便时间为核心指标）的影响；同时评估安瑞克芬对术后肠麻痹（POI）发生率、术后恶心呕吐发生率、住院时长、住院费用及不良事件（如中枢神经系统反应、循环系统异常）的作用，为腹部手术术后镇痛方案的优化提供高质量循证依据。 2.次要研究目的：临床治疗层面合理优化术后镇痛与胃肠功能管理方案、改善患者预后、指导合理用药。药物应用层面：拓展外周限制性 κ 阿片受体激动剂临床价值、凸显药物独特优势，扩大临床应用场景、为同类药物研发与应用提供参考。  

Objectives of Study：

1. Primary Research ObjectiveBy adopting a single-center, randomized, single-blind, controlled design, this study aims to take patients (including elderly patients) undergoing abdominal surgeries such as gastrointestinal, hepatobiliary, and pancreatic surgeries as research subjects. It intends to clarify the effect of the novel peripheral κ-opioid receptor analgesic Anruifen (used during and after surgery) on the recovery of postoperative gastrointestinal function (with the time to first flatus and time to first defecation as core indicators), while ensuring the efficacy of postoperative analgesia. Meanwhile, it will evaluate the impact of Anruifen on the incidence of postoperative ileus (POI), incidence of postoperative nausea and vomiting, length of hospital stay, hospitalization costs, and adverse events (e.g., central nervous system reactions, circulatory system abnormalities), so as to provide high-quality evidence-based basis for the optimization of postoperative analgesia regimens for abdominal surgeries. 2. Secondary Research ObjectivesFrom the perspective of clinical treatment: To rationally optimize the postoperative analgesia and gastrointestinal function management regimens, improve patients' prognosis, and guide rational drug use.

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.ASA 分级 Ⅰ-Ⅱ 级； 2.计划行择期腹腔镜下胃肠、肝胆、胰腺等腹部手术； 3.年龄 18-75 岁； 4.签署知情同意书。

Inclusion criteria

1. ASA physical status classification Ⅰ-Ⅱ; 2. Patients scheduled for elective laparoscopic abdominal surgery (including gastrointestinal surgery, hepatobiliary surgery, pancreatic surgery, etc.); 3. Aged 18-75 years; 4. Signed informed consent form.

排除标准：

1.对安瑞克芬、舒芬太尼或研究中使用的其他麻醉药物（如丙泊酚、顺式阿曲库铵）过敏或有禁忌证；
2.长期使用阿片类药物（如用于慢性疼痛治疗，定义为术前定期使用阿片类药物超过 3 个月）；
3.术前 1 周内使用过影响胃肠动力的药物（如胃肠促动力药、抗胆碱药）；
4.存在严重影响胃肠道功能的预先存在的疾病，如：炎症性肠病（克罗恩病、溃疡性结肠炎）活动期；肠梗阻、麻痹性肠梗阻；严重的胃轻瘫；既往有重大腹部手术史（如胃旁路术、全胃切除术）可能导致解剖结构改变和功能异常；
5.存在严重的心肺功能障碍（如严重心力衰竭、慢性阻塞性肺疾病急性加重期）、肝肾功能衰竭（如肝硬化失代偿期、尿毒症期）；存在中枢神经系统疾病（如癫痫、严重认知功能障碍），可能影响疼痛评估或术后不良反应的判断；
6.急诊手术、创伤手术；
7.手术过程中出现严重并发症（如大出血、休克、需要大量输血、手术时间异常延长）；
8.术中不得不行肠造口术（造瘘）或术后需要进入 ICU 进行长时间机械通气支持（>24 小时）；
9.妊娠期或哺乳期女性；
10.无法配合完成术后随访（如长期居住外地、沟通障碍）；
11.近期（如 3 个月内）参加过其他药物临床试验；

Exclusion criteria：

1. Allergy or contraindication to Anruikafen, Sufentanil, or other anesthetic drugs used in the study (e.g., Propofol, Cisatracurium); 2. Long-term use of opioid drugs (e.g., for chronic pain management, defined as regular use of opioids for more than 3 months before surgery); 3. Use of medications affecting gastrointestinal motility within 1 week prior to surgery (e.g., gastrointestinal prokinetics, anticholinergic drugs); 4. Pre-existing diseases severely affecting gastrointestinal function, such as: active inflammatory bowel disease (Crohn’s disease, ulcerative colitis); intestinal obstruction, paralytic ileus; severe gastroparesis; prior major abdominal surgery (e.g., gastric bypass, total gastrectomy) potentially leading to anatomical alterations and functional abnormalities; 5. Severe cardiopulmonary dysfunction (e.g., severe heart failure, acute exacerbation of chronic obstructive pulmonary disease), hepatic or renal failure (e.g., decompensated liver cirrhosis, uremia); presence of central nervous system disorders (e.g., epilepsy, severe cognitive impairment) that may affect pain assessment or judgment of postoperative adverse reactions; 6. Emergency surgery or trauma surgery; 7. Severe intraoperative complications (e.g., massive hemorrhage, shock, requirement for massive blood transfusion, abnormally prolonged surgical duration); 8. Unavoidable enterostomy performed during surgery or requirement for prolonged postoperative mechanical ventilation support in the ICU (>24 hours); 9. Pregnant or breastfeeding women; 10. Inability to cooperate with postoperative follow-up (e.g., long-term residence outside the area, communication difficulties); 11. Participation in another clinical drug trial within the recent period (e.g., within 3 months);

研究实施时间：

Study execute time：

从 From 2026-01-14 00:00:00至 To 2028-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-05-14 00:00:00 至 To 2026-12-14 00:00:00

干预措施：

Interventions：

组别：

对照组：（舒芬太尼组）

样本量：

 59

Group：

Control Group (Sufentanil Group)

Sample size：

干预措施：

对照组静脉使用舒芬太尼

干预措施代码：

Intervention：

The experimental group received sufentanil intravenously

Intervention code：

组别：

试验组：（安瑞克芬组）

样本量：

 59

Group：

Experimental Group (Anruifen Group)

Sample size：

干预措施：

试验组静脉使用安瑞克芬

干预措施代码：

Intervention：

The experimental group was administered Anruifen intravenously.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 广东医科大学附属医院 

单位级别：

 三级甲等 

Institution
hospital：

Affiliated Hospital of Guangdong Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术后首次肛门排气、排便时间

指标类型：

主要指标

Outcome：

Time to first anal flatus after surgery; Time to first anal defecatio n after surgery

Type：

Primary indicator

测量时间点：

手术术后；术后24h；术后48h；术后7天

测量方法：

通过研究者定时询问（术后每 4-6 小时 1 次）结合患者主动告知，记录患者术后首次出现肛门排气、排便的具体时间（精确到小时），以手术结束时间为起始点计算间隔时长。

Measure time point of outcome：

after surgery /postoperative; 24 hours after surgery; 48 hours after surgery; 7 days after surgery

Measure method：

The specific time of the patient's first postoperative anal flatus and defecation (accurate to the hour) is recorded through regular inquiries by researchers (once every 4-6 hours after surgery) combined with active reporting by the patient. The interval duration is calculated using the end time of the surgery as the starting point.

指标中文名：

静息疼痛视觉模拟评分（VAS）

指标类型：

次要指标

Outcome：

Resting Visual Analogue Scale (VAS) Pain Score

Type：

Secondary indicator

测量时间点：

手术术后；术后24h；术后48h；术后7天

测量方法：

通过研究者定时询问，结合患者主动告知，记录患者状况（精确到小时），以手术结束时间为起始点计算间隔时长，随访调查表收集信息。

Measure time point of outcome：

after surgery /postoperative; 24 hours after surgery; 48 hours after surgery; 7 days after surgery

Measure method：

The patient's condition (recorded accurate to the hour) is documented through regular inquiries by researchers combined with active reporting by the patient. The interval duration is calculated using the end time of the surgery as the starting point, and information is collected via follow-up questionnaires.

指标中文名：

术后胃肠功能综合评估（I-FEED 评分）

指标类型：

次要指标

Outcome：

I-FEED Score

Type：

Secondary indicator

测量时间点：

手术术后；术后24h；术后48h；术后7天

测量方法：

通过研究者定时询问，结合患者主动告知，记录患者状况（精确到小时），以手术结束时间为起始点计算间隔时长，随访调查表收集信息。

Measure time point of outcome：

after surgery /postoperative; 24 hours after surgery; 48 hours after surgery; 7 days after surgery

Measure method：

The patient's condition (recorded accurate to the hour) is documented through regular inquiries by researchers combined with active reporting by the patient. The interval duration is calculated using the end time of the surgery as the starting point, and information is collected via follow-up questionnaires.

指标中文名：

术后肠麻痹（POI）发生率

指标类型：

次要指标

Outcome：

Incidence of Postoperative Ileus, POI

Type：

Secondary indicator

测量时间点：

手术术后；术后24h；术后48h；术后7天

测量方法：

通过研究者定时询问，结合患者主动告知，记录患者状况（精确到小时），以手术结束时间为起始点计算间隔时长，随访调查表收集信息。

Measure time point of outcome：

after surgery /postoperative; 24 hours after surgery; 48 hours after surgery; 7 days after surgery

Measure method：

The patient's condition (recorded accurate to the hour) is documented through regular inquiries by researchers combined with active reporting by the patient. The interval duration is calculated using the end time of the surgery as the starting point, and information is collected via follow-up questionnaires.

指标中文名：

首次经口进食时间

指标类型：

次要指标

Outcome：

Time to First Oral Feeding

Type：

Secondary indicator

测量时间点：

手术术后；术后24h；术后48h；术后7天

测量方法：

通过研究者定时询问，结合患者主动告知，记录患者状况（精确到小时），以手术结束时间为起始点计算间隔时长，随访调查表收集信息。

Measure time point of outcome：

after surgery /postoperative; 24 hours after surgery; 48 hours after surgery; 7 days after surgery

Measure method：

The patient's condition (recorded accurate to the hour) is documented through regular inquiries by researchers combined with active reporting by the patient. The interval duration is calculated using the end time of the surgery as the starting point, and information is collected via follow-up questionnaires.

指标中文名：

术后恶心呕吐

指标类型：

次要指标

Outcome：

Postoperative Nausea and Vomiting

Type：

Secondary indicator

测量时间点：

手术术后；术后24h；术后48h；术后7天

测量方法：

通过研究者定时询问，结合患者主动告知，记录患者状况（精确到小时），以手术结束时间为起始点计算间隔时长，随访调查表收集信息

Measure time point of outcome：

after surgery /postoperative; 24 hours after surgery; 48 hours after surgery; 7 days after surgery

Measure method：

The patient's condition (recorded accurate to the hour) is documented through regular inquiries by researchers combined with active reporting by the patient. The interval duration is calculated using the end time of the surgery as the starting point, and information is collected via follow-up questionnaires.

指标中文名：

住院费用和住院时间

指标类型：

次要指标

Outcome：

Hospitalization Costs and Length of Hospital Stay

Type：

Secondary indicator

测量时间点：

手术术后；术后24h；术后48h；术后7天

测量方法：

通过研究者定时询问，结合患者主动告知，记录患者状况（精确到小时），以手术结束时间为起始点计算间隔时长，随访调查表收集信息

Measure time point of outcome：

after surgery /postoperative; 24 hours after surgery; 48 hours after surgery; 7 days after surgery

Measure method：

The patient's condition (recorded accurate to the hour) is documented through regular inquiries by researchers combined with active reporting by the patient. The interval duration is calculated using the end time of the surgery as the starting point, and information is collected via follow-up questionnaires.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

blood

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 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）：

随机化分组：本研究采用区组随机化方法，以手术类型（胃肠手术、肝胆手术、胰腺手术）?作为分层因素，按?1:1 比例将受试者分配至试验组（安瑞克芬组）与对照组（舒芬太尼组）。 一、随机序列生成 生成工具与执行者 由本研究的执行负责人，使用?SAS 9.4?软件的?PROC PLAN?程序生成随机序列。

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

Randomized Grouping: This study adopts a blocked randomization method, using the type of surgery (gastrointestinal surgery, hepatobiliary surgery, pancreatic surgery) as stratification factors, and allocates subjects to the experimental group (Anruikafen group) and the control group (Sufentanil group) in a 1:1 ratio. I. Random Sequence Generation Generation Tool and Executor: The random sequence was generated by the study's executive principal investigator using the PROC PLAN procedure in SAS 9.4 software.

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：

单盲

Blinding：

Single blind study

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）：

共享方式与时间：本研究计划于2028年12月（即主要研究结果发表后，或数据完全去标识化并完成主要分析后）开始共享数据。届时，所有去标识化的个体参与者数据将通过 （广东医科大学附属医院数据中心/国家全面健康保障信息平台） 进行发布。数据获取依据：可自行在广东医科大学附属医院数据中心与国家全民健康保障信息平台获取，研究类型说明：本研究为预注册研究，我们承诺遵循开放，在保护受试者隐私的前提下，最大限度地实现研究数据的透明与共享。

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

Sharing method and timeline: This study plans to begin sharing data in December 2028 (i.e., after the primary research results are published or after the data are fully de-identified and primary analyses are completed). At that time, all de-identified individual participant data will be made available through (the Data Center of the Affiliated Hospital of Guangdong Medical University / the National Health Security Information Platform). Data access method: Data can be obtained directly from the Data Center of the Affiliated Hospital of Guangdong Medical University and the National Health Security Information Platform. Study type description: This study is a pre-registered study, and we commit to adhering to openness, ensuring the maximum transparency and sharing of research data while protecting the privacy of participants.

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：

数据采集：分术前（人口学、ASA 分级、实验室指标等）、术中（麻醉用药、生命体征、手术信息）、术后（胃肠功能、镇痛效果、安全性指标）三阶段，用专用病例报告表（CRF），由非诊疗专门人员采集，确保与医疗记录一致。 数据管理：双人双份录入并核查，纸质资料锁存（研究结束后存 5 年）、电子数据加密存储（期满销毁）；仅授权人员使用，成果用匿名化数据，且可追溯数据采集录入过程。

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

Data CollectionData is collected in three phases—preoperative, intraoperative, and postoperative—using dedicated Case Report Forms (CRFs). The collection is conducted by specialized personnel who do not engage in clinical diagnosis and treatment, ensuring consistency with medical records.Preoperative phase: Collects demographic data, ASA physical status classification, and laboratory indicators, etc.Intraoperative phase: Records anesthetic medication use, vital signs, and surgical information, etc.Postoperative phase: Gathers data on gastrointestinal function, analgesic efficacy, and safety indicators, etc.Data ManagementData entry and verification: Data is entered twice independently by two staff members and cross-checked to ensure accuracy.Storage and destruction: Paper materials are stored in locked cabinets (retained for 5 years after the study) and electronic data is encrypted (destroyed after the retention period).Access and anonymity: Only authorized personnel have access to the data. Anonymized data is used for research outcomes, and the entire process of data collection and entry is traceable.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-05-09 11:28:49