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Trial search Nation, Province(City) Code of disease Primary sponsor(s) Secondary sponsor(s) Funding source Recruiting status Register status Measure Ethical committee Study type

The effects of pre-stimulation of the vagus nerve on the recovery of gastrointestinal function after ERCP and the perioperative parasympathetic response.

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注册号：

Registration number：

ChiCTR2600123104 

最近更新日期：

Date of Last Refreshed on：

2026-04-21 17:37:01 

注册时间：

Date of Registration：

2026-04-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

耳迷走神经预刺激对ERCP术后胃肠功能恢复与围术期副交感反应的影响

Public title：

The effects of pre-stimulation of the vagus nerve on the recovery of gastrointestinal function after ERCP and the perioperative parasympathetic response.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

耳迷走神经预刺激对ERCP术后胃肠功能恢复与围术期副交感反应的影响

Scientific title：

The effects of pre-stimulation of the vagus nerve on the recovery of gastrointestinal function after ERCP and the perioperative parasympathetic response.

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：

陈明 

研究负责人：

胡宪文 

Applicant：

Chen Ming 

Study leader：

Hu Xianwen 

申请注册联系人电话：

Applicant telephone：

+86 173 7261 2116

研究负责人电话：

Study leader's telephone：

+86 151 5515 9719

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：

3269464524@qq.com

研究负责人电子邮件：

Study leader's E-mail：

efy110302@fy.ahmu.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：

合肥市经济技术开发区芙蓉路678号

研究负责人通讯地址：

合肥市经济技术开发区芙蓉路678号

Applicant address：

678 Furi Road, Hefei Economic and Technological Development Zone

Study leader's address：

678 Furi Road, Hefei Economic and Technological Development Zone

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：

安徽医科大学第二附属医院

Applicant's institution：

The Second Affiliated Hospital of Anhui Medical University

研究负责人所在单位：

安徽医科大学第二附属医院

Affiliation of the Leader：

The Second Affiliated Hospital of Anhui Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

YX2025-333

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：

安徽医科大学第二附属医院医学研究伦理委员会

Name of the ethic committee：

The Second Hospital of Anhul Medlcal University;Ethics Committee Office Action

伦理委员会批准日期：

Date of approved by ethic committee：

2026-01-16 00:00:00

伦理委员会联系人：

张静

Contact Name of the ethic committee：

Zhang Jing

伦理委员会联系地址：

合肥市经济技术开发区芙蓉路678号

Contact Address of the ethic committee：

678 Furi Road, Hefei Economic and Technological Development Zone

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 551 6380 6061

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：

安徽医科大学第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Anhui Medical University

研究实施负责（组长）单位地址：

合肥市经济技术开发区芙蓉路678号

Primary sponsor's address：

678 Furi Road, Hefei Economic and Technological Development Zone

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)：

Country：

China

Province：

Anhui Province

City：

单位(医院)：

安徽医科大学第二附属医院

具体地址：

合肥市经济技术开发区芙蓉路678号

Institution
hospital：

The Second Affiliated Hospital of Anhui Medical University

Address：

678 Furi Road, Hefei Economic and Technological Development Zone

经费或物资来源：

自筹

Source(s) of funding：

Self-raised

Target disease：

Biliary calculi

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：

本研究旨在探讨术前经耳迷走神经预刺激（Transcutaneous Auricular Vagus Nerve Stimulation, TaVNS）对内镜逆行胰胆管造影术（Endoscopic Retrograde Cholangiopancreatography, ERCP）术后早期胃肠功能恢复的促进作用。次要目的旨在进一步探讨术前TaVNS预刺激对ERCP围术期的多维影响，包括对术中副交感异常兴奋事件、对与手术相关的不良事件，以及围术期心率变异性参数和炎症因子水平的影响，进而探索TaVNS作为消化内镜围术期非药物神经调控干预的潜在机制与临床应用价值。  

Objectives of Study：

This study aims to evaluate whether preoperative transcutaneous auricular vagus nerve stimulation (taVNS) preconditioning facilitates early postoperative gastrointestinal functional recovery following endoscopic retrograde cholangiopancreatography (ERCP). Secondary objectives are to characterize the multidimensional periprocedural effects of preoperative taVNS—specifically its impact on intraoperative episodes of parasympathetic hyperexcitability, procedure-related adverse events, perioperative heart rate variability indices, and inflammatory cytokine levels—thereby elucidating the potential mechanisms and clinical utility of taVNS as a non-pharmacological neuromodulatory intervention in the peri-endoscopic setting.

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. 年龄在18–80岁之间，性别不限； 2. 拟接受全麻气管插管下择期行ERCP的患者； 3. ASA病情分级I-III级； 4. 无听力、语言、认知障碍，能够配合完成术后24小时随访； 5. 能够清楚理解研究内容，并自愿签署书面知情同意书； 6. 在干预前的术前评估中无明显自主神经功能障碍表现； 7. BMI介于18.5–28 kg/m^2之间（用于排除极端体型干扰自主神经）； 8. 同时未接受其他潜在影响PONV或胃肠功能的干预（如针灸、其他神经调控等）； 9. 本次检查前72小时内未接受其他镇静、止吐或麻醉药物治疗。

Inclusion criteria

Age 18–80 years, any sex. Scheduled to undergo elective ERCP under general anesthesia with endotracheal intubation. ASA physical status I–III. No hearing, speech, or cognitive impairments; able to complete 24-hour postoperative follow-up. Able to clearly understand the study and willing to provide written informed consent. No evident autonomic dysfunction on preoperative assessment prior to the intervention. BMI 18.5–28 kg/m² (to exclude extreme body habitus that may confound autonomic function). Not concurrently receiving other interventions that could affect postoperative nausea and vomiting (PONV) or gastrointestinal function (e.g., acupuncture, other neuromodulatory therapies). No use of sedatives, antiemetics, or other medications likely to affect autonomic or gastrointestinal function within 72 hours before the procedure.

排除标准：

1. 有咽喉部病变、外伤或手术史（可能影响呛咳及咽痛评估）； 2. 有既往术后恶心呕吐（PONV）史或晕动病史合并中枢神经系统疾病； 3. 严重胃肠道系统疾病（胃癌、食管癌等）； 4. 存在耳廓发炎、外耳道感染或解剖变异，影响电极放置； 5. 明确诊断为迷走神经功能障碍、自主神经病或严重植物神经功能紊乱； 6. 对电流刺激或电极贴片材料存在过敏反应； 7. 正在或近一月内使用止吐药、抗胆碱药物、抗抑郁药、抗癫痫药物等可能影响自主神经功能的药物； 8. 装有心脏起搏器、除颤器或其他植入式电子设备； 9. 合并严重肝肾功能障碍、心脑血管疾病、癫痫或神经系统疾病； 10. 存在严重焦虑、抑郁或其他精神障碍，无法配合干预和评分； 11. 妊娠或哺乳期妇女（需术前签署妊娠排除声明）； 12. 参加其他临床试验未满3个月者； 13. 研究者认为不适宜参加本研究的其他情况（如重大变故、沟通障碍等）。

Exclusion criteria：

1. Lesions, trauma, or prior surgery of the oropharynx/larynx that could confound assessment of cough/gag reflex and postoperative sore throat. 2. History of postoperative nausea and vomiting (PONV) or motion sickness; or concomitant central nervous system disease. 3. Severe gastrointestinal diseases (e.g., gastric cancer, esophageal cancer). 4. Auricular inflammation, external auditory canal infection, or anatomical variations that preclude proper electrode placement. 5. Diagnosed vagal dysfunction, autonomic neuropathy, or severe dysautonomia. 6. Known hypersensitivity to electrical stimulation or to electrode/adhesive materials. 7. Current use of, or use within the past month of, medications that may affect autonomic function (e.g., antiemetics, anticholinergics, antidepressants, antiepileptic drugs). 8. Presence of a cardiac pacemaker, implantable cardioverter-defibrillator (ICD), or other implanted electronic device. 9. Severe hepatic or renal impairment; significant cardiovascular or cerebrovascular disease; epilepsy or other major neurologic disorders. 10. Severe anxiety, depression, or other psychiatric disorders that would preclude cooperation with the intervention and outcome assessments. 11. Pregnant or lactating women (preoperative pregnancy-exclusion declaration required). 12. Participation in another clinical trial within the previous 3 months. 13. Any other condition that, in the investigator's judgment, renders the patient unsuitable for study participation (e.g., major life events, communication barriers).

研究实施时间：

Study execute time：

从 From 2026-01-17 00:00:00至 To 2027-01-14 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-05-01 00:00:00 至 To 2027-01-14 00:00:00  

干预措施：

Interventions：

组别：

TaVNS 组

样本量：

64

Group：

Group T

Sample size：

干预措施：

患者于术前在左侧耳屏或耳甲区域接受刺激，参数为频率25 Hz、脉宽 200μs、电流1-2mA（以患者主观轻度可耐受刺痛为准），持续20 min。

干预措施代码：

Intervention：

Preoperatively, patients will undergo transcutaneous auricular vagus nerve stimulation (taVNS) applied to the left tragus or cymba conchae, delivered at 25 Hz with a 200 μs pulse width and 1–2 mA current—titrated to a mildly perceptible yet tolerable pricking sensation—for 20 minutes.

Intervention code：

组别：

Sham 组

样本量：

64

Group：

Group S

Sample size：

干预措施：

患者于术前在左侧耳屏或耳甲区域接受刺激，参数为脉宽 200μs、频率0 Hz（无实际电流输出），持续20 min。

干预措施代码：

Intervention：

The patient underwent stimulation in the area of the left pinna or ear conch before the procedure, with parameters of pulse width of 200 μs, frequency of 0 Hz (no actual current output), and a duration of 20 minutes.

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)：

  

Country：

China 

Province：

Anhui Province 

City：

 

单位(医院)：

安徽医科大学第二附属医院 

单位级别：

三甲 

Institution
hospital：

The Second Affiliated Hospital of Anhui Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

胃肠功能恢复情况

指标类型：

主要指标

Outcome：

gastrointestinal functional recovery

Type：

Primary indicator

测量时间点：

术后0-4小时及4-24小时

测量方法：

I-FEED量表总分与分级及首次固体进食时间（小时）

Measure time point of outcome：

0–4 hours postoperatively and 4–24 hours postoperatively

Measure method：

Total score and classification of the I-FEED scale, as well as the time (in hours) taken to initiate solid food intake for the first time.

指标中文名：

患者一般情况资料：年龄，性别，BMI、ASA 分级等

指标类型：

次要指标

Outcome：

General patient information: age, gender, BMI, ASA classification, etc.

Type：

Secondary indicator

测量时间点：

术前常规记录

测量方法：

根据入院病例记录

Measure time point of outcome：

Standard pre-operative records.

Measure method：

Based on the records of inpatient cases.

指标中文名：

术中副交感反应

指标类型：

次要指标

Outcome：

Parasympathetic response during surgery.

Type：

Secondary indicator

测量时间点：

手术过程中发生心动过缓（心率<50 次/分）、血压过低（收缩压<80mmHg或血压下降超过30%）、肠痉挛等即刻，记录次数、时间及处理措施。

测量方法：

根据术中监护仪实时监测结果记录

Measure time point of outcome：

Record the occurrence of bradycardia (heart rate < 50 beats per minute), hypotension (systolic blood pressure < 80 mmHg or a drop in blood pressure of more than 30%), and intestinal spasms during surgery, including the frequency, duration, and measures taken to address them.

Measure method：

Based on real-time monitoring results recorded by the intraoperative monitor.

指标中文名：

PONV发生率与补救用药

指标类型：

次要指标

Outcome：

Incidence of PONV and treatment options.

Type：

Secondary indicator

测量时间点：

术后0-4小时及4-24小时

测量方法：

依据WHO分级标准评估患者恶心呕吐情况。Ⅰ级：无恶心、呕吐症状；Ⅱ级：轻微恶心感，但未见呕吐；Ⅲ级：反复干呕；Ⅳ级：吐出胃内容物，且需药物控制。

Measure time point of outcome：

0–4 hours postoperatively and 4–24 hours postoperatively

Measure method：

Evaluate the patient’s nausea and vomiting based on the WHO grading criteria. Grade I: No symptoms of nausea or vomiting; Grade II: Mild nausea, but no vomiting observed; Grade III: Recurrent dry retching; Grade IV: Vomiting of gastric contents, requiring medication to manage.

指标中文名：

HRV参数（LF/HF、RMSSD）

指标类型：

次要指标

Outcome：

HRV parameters (LF/HF, RMSSD).

Type：

Secondary indicator

测量时间点：

入待检室预刺激前 5 min（T0）、诱导前 5 min（T1）、内窥镜过胃大弯曲时（T2）、导管进十二指肠大乳头即刻（T3）、胆总管造影时（T4）、导管出十二指肠大乳头（T5）、ERCP结束（T6）、入恢复室（T7）

测量方法：

患者入室后安静平卧10 min 后开始佩戴心电图记录仪于术后摘除，自行导出心电数据，软件分析各时间点开始后持续 5 min 时长的 ECG

Measure time point of outcome：

5 minutes before entering the examination room for pre-stimulation (T0), 5 minutes before induction (T1), when the endoscope passes through the major curvature of the stomach (T2), immediately after the catheter enters the large papilla of the duodenum (T3), during cholangiography (T4), just before the catheter exits the large papilla of the duodenal bulb (T5), at the conclusion of ERCP (T6), and upon entering the recovery room (T7).

Measure method：

After the patient entered the room and was placed in a quiet, horizontal position for 10 minutes, a electrocardiogram (ECG) recorder was applied. The device was removed post-surgery, and the patient was instructed to manually export the ECG data. The software analyzed the ECG data for a duration of 5 minutes starting from each specific time point.

指标中文名：

术后2h和24h炎症因子（IL-6、TNF-α）水平

指标类型：

次要指标

Outcome：

Levels of inflammatory factors (IL-6, TNF-α) 2 hours and 24 hours post-surgery.

Type：

Secondary indicator

测量时间点：

术后2h和24h

测量方法：

抽取5ml静脉血，用化学发光免疫分析法测量血液中IL-6, TNF-α水平

Measure time point of outcome：

2 and 24 hours postoperatively

Measure method：

Draw 5 mL of venous blood and measure the levels of IL-6 and TNF-α in the blood using a chemiluminescent immunoassay method.

指标中文名：

ERCP术后不良事件（胰腺炎、出血、胆管炎、胆囊炎等）发生率

指标类型：

次要指标

Outcome：

Incidence of adverse events following ERCP (pancreatitis, bleeding, cholangitis, cholecystitis, etc.)

Type：

Secondary indicator

测量时间点：

术后3天

测量方法：

根据患者病历、临床表现及检查指标判断

Measure time point of outcome：

3 days post-surgery.

Measure method：

Based on the patient’s medical records, clinical manifestations, and diagnostic indicators.

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 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）：

采用区组随机（区组大小4或6，1:1），由独立统计人员用R产生序列；分配采用不透明密封信封/中心随机系统隐藏。

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

The study employs block randomization (block size of 4 or 6, 1:1), with sequences generated by independent statisticians using R; allocation is conducted using opaque sealed envelopes/a central randomization system to conceal the assignments.

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、麻醉/内镜团队、结局评估者及统计分析人员均保持盲态。刺激由专职操作者在术前完成，操作者不参与术中管理、随访评估及数据录入。为减少感觉差异导致的破盲风险，所有受试者均被告知刺激感受存在个体差异且与分组无直接对应；设备界面与参数显示对受试者及评估者遮蔽。术后24小时评估盲法成功性（受试者分组猜测及信心评分）。

Blinding：

The participants, the anesthesia/endoscopy team, the outcome assessors, and the statistical analysts remained blinded throughout the study. The stimulation was performed by a dedicated operator pre-operatively, and the operator did not participate in intraoperative management, follow-up assessments, or data entry. To minimize the risk of blinding being compromised due to sensory differences, all participants were informed that individual variations in stimulation perception existed and were not directly correlated with their group assignments. The device interface and parameter displays were obscured from both participants and evaluators. The success of the blinding method was assessed 24 hours post-surgery (guessing of participant groups and confidence ratings).

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

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）：

OSF 开放：公开原始数据日期：【YYYY-MM-DD】 公开方式：去标识化数据集在 Open Science Framework（OSF） 公开 平台名称与网址：OSF（https://osf.io）

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

Open via OSF: Public release date of raw data: [YYYY-MM-DD]. Method: De-identified dataset made publicly available on the Open Science Framework (OSF). Platform & URL: OSF (https://osf.io).

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：

病例记录表：本试验采用专人对入组患者资料进行收集并根据专用表格填写研究记录，用于记录受试者第一手临床试验数据资料。CRF 为统计源文件，由研究者填写。由申办者或其指定人员提供病例报告表（CRF），应按照提供的说明处理 CRF。应由授权的研究人员完整填写所有 CRF。完成的 CRF，第一联交统计分析单位，进行数据录入工作。第一联移交后，CRF 的内容不再作修改。 电子采集和管理系统：建立数据库：由数据管理与统计分析单位负责。核查数据：数值范围和逻辑检查，如有疑问通过监查员向研究者发出询问，研究者应尽快解答并返回，数据管理员根据研究者的回答进行数据修改，确认与录入。数据可溯源性的规定：应保存质量控制性文件，如数据一致性检查，数值范围和逻辑检查的原始记录，盲态核查时的原始记录、研究者与监查员之间交流的疑问记录等。

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

Case report forms (CRFs). Dedicated personnel will collect data from enrolled participants and record them on study-specific CRFs, which constitute the primary source for statistical analyses. CRFs will be provided by the sponsor or its designee and must be handled in accordance with the accompanying instructions. CRFs are completed by authorized investigators/study staff only, with all items filled in fully and accurately. Upon completion, the primary copy of each CRF will be submitted to the statistical analysis unit for data entry. After this primary copy has been transferred, no further changes will be made to the CRF. Electronic data capture and management (EDC). The study database will be established and maintained by the data management and statistical analysis unit. Data verification will include range checks and logical consistency checks. Any discrepancies will generate formal queries that the monitor will issue to the investigators; investigators should respond promptly, and the data manager will implement, confirm, and record amendments based on the investigators’ responses. To ensure data traceability, quality-control documentation will be retained, including original records of data consistency checks, range/logic checks, materials from the blinded review, and query logs/correspondence between investigators and monitors.

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：

  2026-04-21 17:36:57
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