Clinical application of electroacupuncture assisted Opioid-sparing anesthesia in laparoscopic abdominal surgery

注册号:

Registration number:

ITMCTR2024000289

最近更新日期:

Date of Last Refreshed on:

2024-08-24

注册时间:

Date of Registration:

2024-08-24

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

电针辅助低阿片化麻醉在腔镜腹部大手术的临床应用研究

Public title:

Clinical application of electroacupuncture assisted Opioid-sparing anesthesia in laparoscopic abdominal surgery

注册题目简写:

English Acronym:

研究课题的正式科学名称:

电针辅助低阿片化麻醉在腔镜腹部大手术的临床应用研究

Scientific title:

Clinical application of electroacupuncture assisted Opioid-sparing anesthesia in laparoscopic abdominal surgery

研究课题的正式科学名称简写:

Scientific title acronym:

no

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:

蔡俊强

研究负责人:

吴建魏

Applicant:

Cai Junqiang

Study leader:

Wu jianwei

申请注册联系人电话:

Applicant telephone:

+86 1881671214

研究负责人电话:

Study leader's telephone:

+86 15876500650

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:

982191421@qq.com

研究负责人电子邮件:

Study leader's E-mail:

wujianwei97@163.com

申请单位网址(自愿提供):

Study leader's website(voluntary supply):

广东省中医院

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:

广东省广州市越秀区大德路111号

研究负责人通讯地址:

广东省广州市越秀区大德路111号

Applicant address:

No. 111, Dade Road, Yuexiu District, Guangzhou, Guangdong Province

Study leader's address:

No. 111, Dade Road, Yuexiu District, Guangzhou, Guangdong Province

申请注册联系人邮政编码:

Applicant postcode:

510000

研究负责人邮政编码:

Study leader's postcode:

510000

申请人所在单位:

广东省中医院

Applicant's institution:

Guangdong Provincial Hospital of Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

BF2024-158-01

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

广东省中医院伦理委员会

Name of the ethic committee:

Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/6/28 0:00:00

伦理委员会联系人:

李晓彦

Contact Name of the ethic committee:

Li Xiaoyan

伦理委员会联系地址:

广东省广州市越秀区大德路111号

Contact Address of the ethic committee:

No. 111, Dade Road, Yuexiu District, Guangzhou, Guangdong Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 81887233

伦理委员会联系人邮箱:

Contact email of the ethic committee:

llbs@gzucm.edu.cn

研究实施负责(组长)单位:

广东省中医院

Primary sponsor:

Guangdong Provincial Hospital of Chinese Medicine

研究实施负责(组长)单位地址:

广东省中医院

Primary sponsor's address:

Guangdong Provincial Hospital of Chinese Medicine

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):

广州市

Country:

CHINA

Province:

Guangdong

City:

Guangzhou

单位(医院):

广东省中医院

具体地址:

广东省广州市越秀区大德路111号

Institution
hospital:

Guangdong Provincial Hospital of Chinese Medicine

Address:

No. 111, Dade Road, Yuexiu District, Guangzhou, Guangdong Province

经费或物资来源:

广东省中医院

Source(s) of funding:

Guangdong Provincial Hospital of Chinese Medicine

研究疾病:

行腹部大手术的疾病,包括结直肠癌、胃癌、肝癌等

研究疾病代码:

Target disease:

Diseases that require major abdominal surgery, including colorectal cancer, gastric cancer, liver cancer, etc

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

探讨电针辅助低阿片化麻醉对腔镜腹部大手术患者阿片类药物用量、并发症、术中生命体征、术中应激反应、住院时间、远期预后等的影响。

Objectives of Study:

Exploring the effects of electroacupuncture assisted Opioid-sparing anesthesia on opioid dosage, complications, intraoperative vital signs, intraoperative stress response, length of hospital stay, and long-term prognosis in patients undergoing laparoscopic abdominal surgery.

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: 择期行腔镜腹部大手术患者 2: 年龄18-65岁 3: BMI:18.5-28kg/m2 4: 无严重全身性系统性疾病 5: 无相关药物及电针过敏史

Inclusion criteria

1: Patients undergoing elective laparoscopic abdominal surgery 2: Age range: 18-65 years old; 3: BMI:18.5-28kg/m2; 4: No serious systemic diseases; 5: No history of medication or electroacupuncture allergies.

排除标准:

1: 已并发远处转移,其他脏器患有恶性肿瘤,术前接受过放疗、化疗或免疫治疗 2: 患有自身免疫性疾病,1年内曾接受糖皮质激素或免疫抑制剂治疗; 3: 严重的神经系统疾病、肝脏疾病、肾衰竭或ASA评分IV级及以上; 4: 1年内大手术病史; 5: 术前使用阿片类药物患者; 6: 相关穴位部位有感染者。

Exclusion criteria:

1: Has developed distant metastasis, other organs have malignant tumors, and received preoperative radiotherapy, chemotherapy, or immunotherapy; 2: Suffering from autoimmune diseases and having received treatment with glucocorticoids or immunosuppressants within one year; 3: Serious neurological disorders, liver diseases, kidney failure, or ASA score IV or above; 4: History of major surgery within 1 year; 5: Preoperative use of opioid drugs in patients; 6: There are infected individuals in the relevant acupoints.

研究实施时间:

Study execute time:

From 2024-01-01

To      2026-12-31

征募观察对象时间:

Recruiting time:

From 2024-09-01

To      2026-01-01

干预措施:

Interventions:

组别:

电针组(E组)

样本量:

57

Group:

Electroacupuncture group (E group)

Sample size:

干预措施:

于麻醉诱导前30min于患者足三里、内关、合谷和三阴交穴(双侧)电针治疗30min

干预措施代码:

Intervention:

30 minutes before anesthesia induction, electroacupuncture treatment was performed at the Zusanli, Neiguan, Hegu, and Sanyinjiao acupoints (bilateral) of the patient for 30 minutes

Intervention code:

组别:

瑞芬太尼组(R组)

样本量:

57

Group:

Remifentanil group(R)

Sample size:

干预措施:

于麻醉诱导后持续泵注瑞芬太尼0.2-0.5μg/kg/h至术毕前10min

干预措施代码:

Intervention:

Continuously pump remifentanil 0.2-0.5 μ g/kg/h after anesthesia induction until 10 minutes before the end of the operation

Intervention code:

样本总量 Total sample size : 114

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):

广州市

Country:

CHINA

Province:

Guangdong

City:

Guangzhou

单位(医院):

广东省中医院

单位级别:

三甲

Institution/hospital:

Guangdong Provincial Hospital of Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

术后住院天数

指标类型:

次要指标

Outcome:

Postoperative hospitalization days

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后匹兹堡睡眠评分

指标类型:

次要指标

Outcome:

PSQI

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

手术麻醉药物用量

指标类型:

次要指标

Outcome:

Surgical anesthesia medication dosage

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后恢复质量

指标类型:

次要指标

Outcome:

Post-Operative Quality of Recovery Scale (PQRS)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后无复发生存期和总生存期

指标类型:

次要指标

Outcome:

Postoperative recurrence free survival and overall survival

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后30天及90天并发症

指标类型:

次要指标

Outcome:

Postoperative complications at 30 and 90 days

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后疼痛评分

指标类型:

主要指标

Outcome:

NRS

Type:

Primary 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:

组织:

Sample Name:

no

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:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 65
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

本研究采取信封法随机分配方法,将受试者随机分为瑞芬太尼麻醉组(R组)和电针组(E组)。即预先制定随机编码,把每个编码独立放入信封内密封。在确定受试者符合入选/排除标准之后、临床试验之前,由科研助理按次序打开信封进行分组。

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

In this study, the envelope method was used for random allocation, and the subjects were randomly divided into remifentanil anesthesia group (R group) and electroacupuncture group (E group). Pre assign random codes and seal each code independently in an envelope. After confirming that the subjects meet the inclusion/exclusion criteria and before the clinical trial, the research assistant opens the envelopes in order for grouping.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

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

no

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:

CRF表

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

CRF

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above