ChiCTR2600117962 版本V1.0 版本创建时间2026/01/30 15:35:53 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：

ChiCTR2600117962 

最近更新日期：

Date of Last Refreshed on：

2026-01-30 15:35:36 

注册时间：

Date of Registration：

2026-01-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

经皮耳迷走神经刺激联合环泊酚在无痛胃肠镜中的应用：一项前瞻性、随机、双盲的非劣效性研究

Public title：

Transcutaneous Auricular Vagus Nerve Stimulation Combined with Ciprofol in Painless Gastrointestinal Endoscopy: A Prospective, Randomized, Double-Blind Non-Inferiority Study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

经皮耳迷走神经刺激联合环泊酚在无痛胃肠镜中的应用：一项前瞻性、随机、双盲、安慰剂对照的临床研究

Scientific title：

Transcutaneous Auricular Vagus Nerve Stimulation Combined with Ciprofol in Painless Gastrointestinal Endoscopy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study

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：

彭浩彬 

研究负责人：

彭浩彬 

Applicant：

Haobin Peng 

Study leader：

Haobin Peng 

申请注册联系人电话：

Applicant telephone：

+86 188 1871 1784

研究负责人电话：

Study leader's telephone：

+86 188 1871 1784

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：

476736369@qq.com

研究负责人电子邮件：

Study leader's E-mail：

476736369@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：

广东省佛山市顺德区大良金沙大道12号

研究负责人通讯地址：

广东省佛山市顺德区大良金沙大道12号

Applicant address：

No. 12, Jinsha Avenue, Daliang, Shunde District, Foshan City, Guangdong Province

Study leader's address：

No. 12, Jinsha Avenue, Daliang, Shunde District, Foshan City, 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：

广州中医药大学顺德医院(佛山市顺德区中医院)

Applicant's institution：

Guangzhou University of Traditional Chinese Medicine ShunDe Traditional Chinese Medicine Hospital, Foshan, Guangdong

研究负责人所在单位：

广州中医药大学顺德医院(佛山市顺德区中医院)

Affiliation of the Leader：

Guangzhou University of Traditional Chinese Medicine ShunDe Traditional Chinese Medicine Hospital, Foshan, Guangdong

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：

KY-2025096

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：

广州中医药大学顺德医院医学伦理委员会

Name of the ethic committee：

Ethics Committee of Shunde Hospital, Guangzhou University of Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025-06-13 00:00:00

伦理委员会联系人：

巫朝银

Contact Name of the ethic committee：

Chaoyin Wu

伦理委员会联系地址：

广东省佛山市顺德区大良金沙大道12号

Contact Address of the ethic committee：

No. 12, Jinsha Avenue, Daliang, Shunde District, Foshan City, Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 757 2232 2561

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：

广州中医药大学顺德医院(佛山市顺德区中医院)

Primary sponsor：

Guangzhou University of Traditional Chinese Medicine ShunDe Traditional Chinese Medicine Hospital, Foshan, Guangdong

研究实施负责（组长）单位地址：

广东省佛山市顺德区大良金沙大道12号

Primary sponsor's address：

No. 12, Jinsha Avenue, Daliang, Shunde District, Foshan City, 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

市(区县)：

佛山

Country：

China

Province：

Guangdong

City：

Foshan

单位(医院)：

广州中医药大学顺德医院(佛山市顺德区中医院)

具体地址：

广东省佛山市顺德区大良金沙大道12号

Institution
hospital：

Guangzhou University of Traditional Chinese Medicine ShunDe Traditional Chinese Medicine Hospital, Foshan, Guangdong

Address：

No. 12, Jinsha Avenue, Daliang, Shunde District, Foshan City, Guangdong Province

经费或物资来源：

2025年度广州中医药大学校院联合科技创新基金-顺德医院共建项目

Source(s) of funding：

2025 Guangzhou University of Chinese Medicine Joint Technology Innovation Fund - Collaborative Project with Shunde Hospital

Target disease：

Sedation/Pain Management in Gastrointestinal Endoscopy

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 上市后药物 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究旨在通过一项前瞻性、随机、双盲、安慰剂对照、三臂、非劣效性临床试验，评估在行无痛胃镜联合结肠镜检查的患者中，应用“经皮耳迷走神经刺激（taVNS）联合环泊酚”的镇静方案，在患者术后24小时整体恢复质量方面是否不劣于当前标准的“舒芬太尼联合环泊酚”方案。同时，本研究将首先验证试验灵敏度，即确认标准方案（舒芬太尼+环泊酚）在主要结局上优于无阿片类药物的安慰剂方案（假刺激+环泊酚），从而为后续的非劣效比较提供逻辑基础。本研究将患者报告的术后24小时恢复质量作为主要终点，系统评价taVNS替代阿片类药物在无痛胃肠镜联合检查中的可行性与优势，旨在为优化“无阿片化”或“阿片节用”的舒适化内镜镇静策略提供高级别循证医学证据。  

Objectives of Study：

This study aims to evaluate, through a prospective, randomized, double-blind, placebo-controlled, three-arm non-inferiority clinical trial, whether the sedation protocol of "transcutaneous auricular vagus nerve stimulation (taVNS) combined with ciprofol" is not inferior to the current standard protocol of "sufentanil combined with ciprofol" in terms of overall recovery quality within 24 hours postoperatively in patients undergoing painless gastroscopy combined with colonoscopy. Additionally, this study will first validate the sensitivity of the trial by confirming that the standard protocol (sufentanil + ciprofol) is superior to the non-opioid placebo protocol (sham stimulation + ciprofol) regarding the primary outcome, thereby providing a logical basis for subsequent non-inferiority comparisons. This study will use patient-reported recovery quality within 24 hours postoperatively as the primary endpoint and systematically evaluate the feasibility and advantages of taVNS as a replacement for opioids in painless gastrointestinal endoscopy. The aim is to provide high-level evidence for optimizing "opioid-free" or "opioid-sparing" comfort sedation strategies in endoscopy.

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≥18岁； 2. 18 kg/m^2<= BMI <=30 kg/m^2； 3. 美国麻醉医师协会（ASA）分级Ⅰ-Ⅲ级； 4. 受试者自愿参加本试验，并计划同时进行胃肠镜检查。

Inclusion criteria

1. Age >= 18 years; 2. 18 kg/m2 <= BMI <= 30 kg/m2; 3. American Society of Anesthesiologists (ASA) physical status classification I-III; 4. Subject voluntarily participates in this trial and plans to undergo gastrointestinal endoscopy simultaneously.

排除标准：

1. 术前24小时内使用镇静、镇痛或精神类药物； 2. 有taVNS治疗史者或对任何一种药物成分过敏者； 3. 患有严重心脏、肝、肾、脑或肺部疾病的患者，如NYHA心功能III-IV级、Child-Pugh C级、肌酐清除率<30 mL/min等； 4. 胃镜检查操作时间超过30分钟或总检查时间（从胃镜进镜至结肠镜退镜）超过60分钟； 5. 妊娠或哺乳期妇女； 6. 精神系统疾病（精神分裂症、躁狂症、双向情感障碍、精神错乱等）及长期服用精神类药物史及认知功能障碍患者； 7. 存在耳部疾病或皮肤破损影响 taVNS 贴片放置者，如急性外耳道炎、耳廓畸形等。 8. 存在心脏起搏器或颅内金属植入物等taVNS禁忌症者； 9. 酗酒史。

Exclusion criteria：

1. Use of sedatives, analgesics, or psychotropic drugs within 24 hours prior to surgery; 2. History of taVNS treatment or allergy to any drug component; 3. Patients with severe heart, liver, kidney, brain, or lung diseases, such as NYHA heart function class III-IV, Child-Pugh class C, creatinine clearance <30 mL/min, etc.; 4. Endoscopic operation time exceeding 30 minutes or total examination time (from the insertion of the gastroscope to the withdrawal of the colonoscope) exceeding 60 minutes; 5. Pregnant or breastfeeding women; 6. Patients with psychiatric disorders (schizophrenia, mania, bipolar disorder, psychosis, etc.), a history of long-term use of psychotropic drugs, and cognitive impairment; 7. Presence of ear diseases or skin lesions affecting the placement of the taVNS patch, such as acute otitis externa or ear deformities; 8. Contraindications for taVNS such as the presence of a pacemaker or intracranial metallic implants; 9. History of alcohol abuse.

研究实施时间：

Study execute time：

从 From 2025-06-01 00:00:00至 To 2027-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-04-01 00:00:00 至 To 2026-09-30 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

67

Group：

Control Group

Sample size：

干预措施：

接受静脉舒芬太尼（0.1 μg/kg）及假taVNS刺激（仅予初始30秒微弱刺激）。所有患者均统一静脉给予环泊酚（诱导剂量0.4 mg/kg，术中按需追加）进行镇静。

干预措施代码：

Intervention：

Intravenous sufentanil (0.1 μg/kg) and sham taVNS stimulation were administered (with only an initial 30 seconds of weak stimulation). . All patients received an intravenous dose of ciprofol (induction dose 0.4 mg/kg, additional doses as needed during the procedure) for sedation.

Intervention code：

组别：

试验组

样本量：

67

Group：

Experimental Group

Sample size：

干预措施：

接受静脉生理盐水安慰剂及真taVNS刺激。刺激于麻醉诱导前开始，持续30分钟后停止，随后进行麻醉诱导与胃肠镜检查。所有患者均统一静脉给予环泊酚（诱导剂量0.4 mg/kg，术中按需追加）进行镇静。

干预措施代码：

Intervention：

Intravenous saline placebo and true taVNS stimulation were administered. Stimulation began before anesthesia induction and continued for 30 minutes before stopping, followed by anesthesia induction and gastrointestinal endoscopy. All patients received an intravenous dose of ciprofol (induction dose 0.4 mg/kg, with additional doses as needed during the procedure) for sedation.

Intervention code：

组别：

安慰剂组

样本量：

47

Group：

Placebo Group

Sample size：

干预措施：

接受静脉生理盐水安慰剂及假taVNS刺激（仅予初始30秒微弱刺激）。所有患者均统一静脉给予环泊酚（诱导剂量0.4 mg/kg，术中按需追加）进行镇静。

干预措施代码：

Intervention：

Intravenous saline placebo and sham taVNS stimulation were administered (with only an initial 30 seconds of weak stimulation). All patients received an intravenous dose of ciprofol (induction dose 0.4 mg/kg, with additional doses as needed during the procedure) for sedation.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

 佛山 

Country：

China 

Province：

Guangdong 

City：

Foshan 

单位(医院)：

广州中医药大学顺德医院(佛山市顺德区中医院) 

单位级别：

三级 

Institution
hospital：

Guangzhou University of Traditional Chinese Medicine ShunDe Traditional Chinese Medicine Hospital, Foshan, Guangdong

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

术后24小时恢复质量

指标类型：

主要指标

Outcome：

Postoperative 24-hour recovery quality

Type：

Primary indicator

测量时间点：

术后24小时

测量方法：

使用患者报告的恢复质量量表（QoR-15）进行评价。对已出院患者通过结构化电话访谈进行，对住院患者进行现场问卷评估。评分范围为0-150分，分数越高表示恢复质量越好。

Measure time point of outcome：

Postoperative 24 hours

Measure method：

The evaluation was conducted using the Patient-Reported Outcomes Quality of Recovery Scale (QoR-15). For discharged patients, structured telephone interviews were conducted, while inpatients underwent on-site questionnaire assessments. The scoring range is from 0 to 150 points, with higher scores indicating better quality of recovery.

指标中文名：

术后1小时恢复质量

指标类型：

次要指标

Outcome：

Postoperative 1-hour recovery quality

Type：

Secondary indicator

测量时间点：

术后1小时

测量方法：

使用患者报告的恢复质量量表（QoR-15），在恢复室由研究助理进行现场评估。评分范围0-150分，分数越高恢复越好。

Measure time point of outcome：

Postoperative 1 hour

Measure method：

Using the Patient-Reported Outcomes Quality of Recovery Scale (QoR-15), on-site assessments were conducted by research assistants in the recovery room. The scoring range is from 0 to 150 points, with higher scores indicating better recovery.

指标中文名：

围术期内不良事件的发生率及严重程度

指标类型：

次要指标

Outcome：

Incidence and severity of adverse events during the perioperative period

Type：

Secondary indicator

测量时间点：

从首次研究干预（开始taVNS刺激/推注研究药物）前的基础值评估开始，持续至术后24小时随访结束。

测量方法：

术前taVNS刺激相关不良事件，如皮肤红斑、瘙痒和心律失常；术中相关不良事件，包括呼吸抑制（如SpO2<90%持续10秒或更长时间）、低血压（收缩压<90mmHg或较基础值下降≥20%）、心动过缓（心率<50 次/分）、注射痛和镇静不足（体动）；术后恢复期不良事件（至24h随访），如恶心呕吐、头晕、头痛、嗜睡和咽喉不适等。全研究周期的严重不良事件，如严重过敏、心脑血管意外、意外伤害等（一经发生，需按规范立即上报并详细记录）。

Measure time point of outcome：

The assessment will begin from the baseline values before the first research intervention (initiation of taVNS stimulation/injection of the research drug) and will continue until the completion of the postoperative 24-hour follow-up.

Measure method：

Preoperative adverse events related to transcutaneous auricular vagus nerve stimulation (taVNS), such as skin erythema,pruritus and arrhythmia; intraoperative adverse events, including respiratory depression (e.g., SpO? < 90% lasting 10 seconds or longer), hypotension (systolic blood pressure<90 mmHg or a decrease≥20% from baseline), bradycardia (heart rate<50 beats per minute), injection pain, and inadequate sedation (body movement); postoperative adverse events during the recovery period.

指标中文名：

术中环泊酚各阶段用量及丙泊酚补救情况

指标类型：

次要指标

Outcome：

Intraoperative remifentanil dosages at each stage and the use of propofol rescue.

Type：

Secondary indicator

测量时间点：

在麻醉开始至检查结束时

测量方法：

环泊酚总用量及各阶段（胃镜、结肠镜）用量在麻醉开始至检查结束时记录（单位：mg），丙泊酚补救的发生率（%）及剂量（mg）在同一时段内统计。

Measure time point of outcome：

From the start of anesthesia to the end of the examination.

Measure method：

The total dose of remifentanil and the dosages at each stage (gastroscopy, colonoscopy) will be recorded from the start of anesthesia to the end of the examination (unit: mg). The incidence (%) and dosage (mg) of propofol rescue will be summarized within the same timeframe.

指标中文名：

镇静深度 (Ramsay评分)

指标类型：

次要指标

Outcome：

Depth of sedation (Ramsay score)

Type：

Secondary indicator

测量时间点：

在麻醉开始至检查结束时

测量方法：

采用Ramsay镇静评分（1-6分，分数越高镇静越深），分别在给药前、检查过程中（每5分钟一次）、检查结束时进行评估。

Measure time point of outcome：

From the start of anesthesia to the end of the examination.

Measure method：

The Ramsay sedation scale (1-6 points, with higher scores indicating deeper sedation) will be assessed before administration, during the examination (every 5 minutes), and at the end of the examination.

指标中文名：

内镜医生和患者满意度

指标类型：

次要指标

Outcome：

Satisfaction of Endoscopists and Patients

Type：

Secondary indicator

测量时间点：

胃肠镜检查操作结束后5分钟内和患者离开胃肠镜室前

测量方法：

使用临床满意度量表（CSSI）评估内镜医生对操作条件的满意度，包括胃肠蠕动情况、患者配合度等，以及患者满意度。

Measure time point of outcome：

Within 5 minutes after the completion of the gastrointestinal endoscopy procedure and before the patient leaves the endoscopy room.

Measure method：

The Clinical Satisfaction Index (CSSI) will be used to assess endoscopists' satisfaction with the operating conditions, including gastrointestinal motility, patient cooperation, and patient satisfaction.

指标中文名：

操作与恢复效率指标

指标类型：

次要指标

Outcome：

Operational and Recovery Efficiency Indicators

Type：

Secondary indicator

测量时间点：

术中和术后

测量方法：

记录各阶段操作时间（胃镜、结肠镜、转换间隔及总时长）、是否实施活检/治疗、苏醒时间（从检查结束到呼唤能睁眼的时间）和离院时间（从检查结束到符合离院标准的时间）。

Measure time point of outcome：

Intraoperative and postoperative

Measure method：

Record the operation time at each stage during and after the procedure (gastroscopy, colonoscopy, transfer intervals, and total duration), whether a biopsy/treatment was performed, awakening time (the time from the end of the examination until the patient can respond to verbal stimuli), and discharge time (the time from the end of the examination until the patient meets discharge criteria).

指标中文名：

盲法有效性评估

指标类型：

次要指标

Outcome：

Blind efficacy assessment

Type：

Secondary indicator

测量时间点：

患者评估时间为最后一次随访（如术后24h），结局评估者在完成所有负责的评估后

测量方法：

研究结束时，将使用标准化的盲法有效性评估问卷，对患者和结局评估者（麻醉医生、随访护士）进行询问，以评估设盲的成功率。计算“猜测正确率”和分析“不知道”选项的比例，使用二项分布检验和卡方检验进行统计。

Measure time point of outcome：

Patient assessment will occur at the final follow-up (e.g., 24 hours post-surgery), while outcome evaluators will respond after completing all their assigned assessments.

Measure method：

At the end of the study, a standardized blinded efficacy assessment questionnaire will be administered to both patients and outcome evaluators (anesthesiologists, follow-up nurses) to assess the success rate of blinding. The "correct guess rate" will be calculated, and the proportion of "I don't know" responses will be analyzed, using binomial distribution tests and chi-square tests for statistical analysis.

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 / 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）：

采用动态区组随机化法，使用SAS 9.4软件生成随机分配序列。针对总样本量181例，设定目标分配比例为S组（对照组）: T组（实验组）: P组（安慰剂组）= 1:1:0.7（即最小整数比10:10:7）。通过设计多种区组模式（区组长度包括4、5、6、8、9、10、12等），在每个区组内保持近似目标比例，并采用动态优化算法实时选择最合适的区组模式，确保在完成181例分配时，各组实际例数精确符合理论值（S组67例、T组67例、P组47例）。

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

A dynamic block randomization method was used, with the randomization allocation sequence generated using SAS 9.4 software. For a total sample size of 181 subjects, the target allocation ratio was set as Group S (control): Group T (experimental): Group P (placebo) = 1:1:0.7 (i.e., the minimum integer ratio of 10:10:7). By designing multiple block patterns (block lengths including 4, 5, 6, 8, 9, 10, 12, etc.), the approximate target ratio was maintained within each block, and a dynamic optimization algorithm was used to select the most appropriate block pattern in real-time, ensuring that upon completion of the allocation of 181 subjects, the actual number of subjects in each group precisely matched the theoretical values (67 in Group S, 67 in Group T, and 47 in Group P).

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：

此过程确保受试者、内镜医生、麻醉医生及结局评估者在分组实施前后均无法预知分配结果，从而保证分配隐蔽性和盲法的完整性。

Blinding：

This process guarantees that the participant, endoscopist, anesthesiologist, and outcome assessors will be unaware of the allocation results both before and after group implementation, thereby ensuring the concealment of allocation and the integrity of blinding.

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）：

原始数据计划于2026年12月在中国临床试验注册中心的ResMan原始数据共享平台（IPD共享平台）上公开，并可通过http://www.medresman.org.cn进行访问。

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

The raw data are planned to be made publicly available on the ResMan raw data–sharing platform (IPD sharing platform) of the Chinese Clinical Trial Registry in December 2026 and can be accessed at http://www.medresman.org.cn.

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：

本研究的所有数据将使用根据方案专门设计的纸质病例记录表（CRF）进行采集。研究护士在每次访视后，需及时、完整、准确、规范地填写CRF，所有修改必须签注姓名和日期。数据录入阶段，由两名项目秘书进行双人独立录入到电子数据库中，随后进行一致性比对与人工逻辑核查。所有发现的数据疑问（如缺失、异常或逻辑矛盾）将由数据管理员生成纸质数据疑问表，返回给原始填写者（研究护士）进行核查、说明与修正，修正过程需经主要研究者审核，所有疑问表均需归档保存。在主要指标采集完成且所有疑问解决后，最终数据库将进行冻结与锁定，锁定后的数据方用于统计分析。整个数据管理过程将严格遵循GCP原则，并通过上述明确分工与多重核对机制确保数据的真实性、准确性、完整性和可溯源性。

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

All data in this study will be collected using paper Case Report Forms (CRFs) that are specifically designed according to the protocol. Research nurses are required to fill out the CRFs promptly, completely, accurately, and in accordance with standards after each visit, with all modifications signed with their name and dated. During the data entry phase, two project secretaries will independently enter the data into an electronic database, followed by consistency comparison and manual logical verification. Any identified data queries (such as missing, abnormal, or logically inconsistent data) will be generated into paper data query forms by the data manager and returned to the original data entry personnel (research nurses) for verification, clarification, and correction. The correction process must be reviewed by the principal investigator, and all query forms must be archived. Once the collection of primary endpoints is complete and all queries have been resolved, the final database will be frozen and locked, with only the locked data used for statistical analysis. The entire data management process will strictly adhere to GCP principles, ensuring the authenticity, accuracy, completeness, and traceability of the data through clear division of responsibilities and a multi-check mechanism.

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：

  2026-01-30 15:35:36