简体中文|English
检索试验 按国家、省（市）统计 按疾病代码统计 按试验实施单位统计 按试验主办单位统计 按经费或物资来源统计 按征募研究对象情况统计 按注册状态统计 按干预措施统计 按伦理委员会统计 按研究类型统计
经皮穴位电刺激对腹腔镜全子宫切除患者预保温作用的观察
下载XML文档

注册号：

Registration number：

 ChiCTR2300075864 

最近更新日期：

Date of Last Refreshed on：

 2024-02-21 19:59:51 

注册时间：

Date of Registration：

 2023-09-18 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

经皮穴位电刺激对腹腔镜全子宫切除患者预保温作用的观察

Public title：

Observation on the effect of percutaneous acupoint electrical stimulation on pre insulation in patients undergoing laparoscopic total hysterectomy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

经皮穴位电刺激对腹腔镜全子宫切除患者预保温作用的观察

Scientific title：

Observation on the effect of percutaneous acupoint electrical stimulation on pre insulation in patients undergoing laparoscopic total hysterectomy

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：

牛金柱 

研究负责人：

李坤 

Applicant：

Niu Jinzhu 

Study leader：

Li Kun 

申请注册联系人电话：

Applicant telephone：

 +86 139 3463 9590

研究负责人电话：

Study leader's
telephone：

+86 139 3462 9201

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：

 niujz264@163.com

研究负责人电子邮件：

Study leader's E-mail：

 895863342@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：

山西省太原市迎泽区桥东街30号

研究负责人通讯地址：

山西省太原市迎泽区桥东街30号

Applicant address：

30 Qiaodong Street, Yingze District, Taiyuan, Shanxi

Study leader's address：

30 Qiaodong Street, Yingze District, Taiyuan, Shanxi

申请注册联系人邮政编码：

Applicant postcode：

 030001

研究负责人邮政编码：

Study leader's postcode：

 030001

申请人所在单位：

中国人民解放军联勤保障部队第985医院麻醉科

Applicant's institution：

Anesthesia Department of the 985th Hospital of the Joint Logistics Support Force of the People's Liberation Army

研究负责人所在单位：

中国人民解放军联勤保障部队第985医院麻醉科

Affiliation of the Leader：

Anesthesia Department of the 985th Hospital of the Joint Logistics Support Force of the People's Liberation Army

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：

 伦审(技)第40号; 伦审(技)第56号

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：

中国人民解放军联勤保障部队第985医院卫勤处（伦理委员会）

Name of the ethic committee：

Health Service Office of the 985th Hospital of the People's Liberation Army Joint Service Support Force (Ethics Committee)

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-03-23 00:00:00

伦理委员会联系人：

李祥娟

Contact Name of the ethic committee：

Li Xiangjuan

伦理委员会联系地址：

山西省太原市迎泽区桥东街30号

Contact Address of the ethic committee：

30 Qiaodong Street, Yingze District, Taiyuan, Shanxi

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 138 0341 9339

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：

中国人民解放军联勤保障部队第985医院

Primary sponsor：

The 985th Hospital of the Joint Service Support Force of the People's Liberation Army

研究实施负责（组长）单位地址：

山西省太原市迎泽区桥东街30号

Primary sponsor's address：

30 Qiaodong Street, Yingze District, Taiyuan, Shanxi

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

山西

市(区县)：

太原

Country：

China

Province：

Shanxi

City：

Taiyuan

单位(医院)：

中国人民解放军联勤保障部队第985医院

具体地址：

山西省太原市迎泽区桥东街30号

Institution
hospital：

The 985th Hospital of the Joint Service Support Force of the People's Liberation Army

Address：

30 Qiaodong Street, Yingze District, Taiyuan, Shanxi

经费或物资来源：

中国人民解放军联勤保障部队第985医院

Source(s) of funding：

Project of the 985th Hospital of the Joint Service Support Force of the People's Liberation Army

研究疾病：

腹腔镜全子宫切除  

Target disease：

Laparoscopic total hysterectomy

研究疾病代码：

68.405

Target disease code：

68.405

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

妇科腹腔镜手术的二氧化碳气腹可以导致术中低体温，术后恢复时间延长。术前实施经皮穴位电刺激（TEAS）预保温能有效提升患者术中的核心体温，降低低体温的发生率。本研究旨在观察术前经皮穴位电刺激大椎及神门、内关穴对腹腔镜全子宫切除患者的预保温效果。  

Objectives of Study：

Carbon dioxide pneumoperitoneum in gynecological Laparoscopy can lead to hypothermia during the operation and prolong the recovery time after the operation. Preoperative implementation of percutaneous acupoint electrical stimulation (TEAS) pre insulation can effectively increase the core body temperature of patients during surgery and reduce the incidence of hypothermia. This study aims to observe the pre insulation effect of preoperative percutaneous acupoint electrical stimulation of Dazhui, Shenmen, and Neiguan points on patients undergoing laparoscopic total hysterectomy.

药物成份或治疗方案详述：

本研究经医院伦理审查委员会批准,并与患者签署知情同意书。 采用随机数字表法分为2组：按照随机分组TEAS穴位理疗电极刺激组(T组)和对照组(C组)。受试者穴位位置根据中华人民共和国第二版标准针刺命名法确定(GB/12346-2006)，大椎穴（DU14）及双侧神门穴（HT7）、内关穴（PC6）。于手术前天下午到病房访视病人，穴位处用酒精清洁皮肤后，贴上脉冲加热凝胶电极片（驼人医疗器械TR-1型），于平卧保暖30 min(T0)后开始进行TEAS 30min，实验T组给予的穴位刺激采用疏密波，频率2 Hz/100 Hz，强度8~30 mA(取患者能忍受的最大强度值，温度为38-40℃，C组仅在穴位上贴电极片但不给予电刺激，但告诉受试者可能感受不到，记录治疗前后的体温变化。手环监测记录治疗当晚睡眠质量。 手术当日患者入室后穴位治疗方法按分组与术前方法相同。均采用医用控温仪（珠海黑马医学仪器）术中持续保暖，采用恒温储液柜（FYL-YS828L,北京福意联电器）加温输注相同温度的液体及冲洗液(22 ℃)。迈瑞（T9）麻醉监护仪连续监测治疗前30 min(T0)，麻醉后30min(T0)，手术后30min(T1)，60min(T2)，手术后120min(T3)，手术后180min(T4)及手术结束后(T5)体温和是否发生寒战。 

Description for medicine or protocol of treatment in detail：

This study was approved by the hospital ethics review committee and an informed consent form was signed with the patient. Divide into two groups using a random number table method: TEAS acupoint therapy electrode stimulation group (T group) and control group (C group). The acupoint positions of the subjects were determined according to the standard acupuncture nomenclature of the second edition of the China (GB/12346-2006), Dazhui point (DU14), bilateral Shenmen point (HT7), and Neiguan point (PC6). In the afternoon of the day before the operation, we visited the patient in the ward, cleaned the skin with alcohol at the acupoint, pasted the pulse heating gel electrode (Camel Medical Instrument TR-1), and started TEAS for 30 minutes after lying on the back to keep warm for 30 minutes (T0). The acupoint stimulation of experimental group T was given by density wave, with the frequency of 2 Hz/100 Hz, Intensity 8-30 mA (take the maximum intensity value that the patient can tolerate, with a temperature of 38-40 ℃. Group C only applies electrode pads to acupoints but does not provide electrical stimulation, but informs the subjects that they may not feel it. Record the temperature changes before and after treatment. Monitor the sleep quality of the night of treatment with a wristband. On the day of surgery, the acupoint treatment method for patients entering the room is the same as the preoperative method according to their grouping. All patients were kept warm during surgery using a medical temperature controller (Zhuhai Heima Medical Instrument), and a constant temperature liquid storage cabinet (FYL-YS828L, Beijing Fuyilian Electric Appliances) was used to warm up and infuse the same temperature liquid and flushing solution (22 ℃). The Mindray (T9) anesthesia monitor continuously monitors body temperature and whether shivers occur 30 minutes before treatment (T0), 30 minutes after anesthesia (T0), 30 minutes after surgery (T1), 60 minutes after surgery (T2), 120 minutes after surgery (T3), 180 minutes after surgery (T4), and after surgery (T5). 

纳入标准：

Inclusion criteria

排除标准：

1.穴位局部有感染的患者； 2.有腰背部神经损伤的患者； 3.有起搏器等体内电子植入物的患者； 4.术前4周内有感染性发热史的患者； 5.术前2周内服用影响体温调节药物的患者； 6.手术时间小于1 h或大于4 h的患者； 7.不能配合完成研究计划的患者。

Exclusion criteria：

1. Patients with local infection at acupoints; 2. Patients with lower back nerve injury; 3. Patients with internal electronic implants such as pacemakers; 4. Patients with a history of infectious fever within 4 weeks before surgery; 5. Patients taking drugs that affect Thermoregulation within 2 weeks before operation; 6. Patients with surgery time less than 1 hour or more than 4 hours; 7. Patients who cannot cooperate to complete the research plan.

研究实施时间：

Study execute time：

从 From 2022-05-07 00:00:00至 To 2025-01-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-05-18 00:00:00 至 To 2024-12-30 00:00:00

干预措施：

Interventions：

组别：

穴位电刺激组(T组)

样本量：

 48

Group：

Acupoint electrical stimulation group (T group)

Sample size：

干预措施：

TEAS穴位理疗电极刺激组(T组)。受试者穴位选择，根据中华人民共和国第二版标准针刺命名法确定(GB/12346-2006)，大椎穴（DU14）及双侧神门穴（HT7）、内关穴（PC6）。于手术前天下午到病房访视病人，穴位处用酒精清洁皮肤后，贴上脉冲加热凝胶电极片（驼人医疗器械TR-1型），于平卧保暖30 min(T0)后开始进行TEAS 30min，实验T组给予的穴位刺激采用疏密波，频率2 Hz/100 Hz，强度8~30 mA(取患者能忍受的最大强度值，温度为38-40℃，手环监测记录治疗当晚睡眠质量。 手术当日患者入室后穴位治疗方法按分组与术前方法相同。均采用医用控温仪（珠海黑马医学仪器）术中持续保暖，采用恒温储液柜（FYL-YS828L,北京福意联电器）加温输注相同温度的液体及冲洗液(22 ℃)。迈瑞（T9）麻醉监护仪连续监测治疗前30 min(T0)，麻醉后30min(T0)，手术后60min(T1)，手术后120min(T2)，手术后180min(T3)及手术结束后(T4)体温和是否发生寒战。

干预措施代码：

Intervention：

TEAS acupoint physical therapy electrode stimulation group (T group). The acupoints of the subjects were selected according to the standard acupuncture nomenclature of the second edition of the China (GB/12346-2006), Dazhui (DU14), bilateral Shenmen (HT7) and Neiguan (PC6). In the afternoon of the day before the operation, we visited the patient in the ward, cleaned the skin with alcohol at the acupoint, pasted the pulse heating gel electrode (Camel Medical Instrument TR-1), and started TEAS for 30 minutes after lying on the back to keep warm for 30 minutes (T0). The acupoint stimulation of experimental group T was given by density wave, with the frequency of 2 Hz/100 Hz, The intensity is 8-30 mA (taking the maximum intensity value that the patient can tolerate, with a temperature of 38-40 ℃. The wrist strap monitoring records the sleep quality of the night of treatment. On the day of surgery, the patient enters the room and the acupoint treatment method is grouped according to the same preoperative method. All patients use a medical temperature controller (Zhuhai Heima Medical Instrument) to keep warm during surgery, and a constant temperature liquid storage cabinet (FYL-YS828L, Beijing Fuyilian Electric Appliances) is used to warm and infuse the same temperature liquid and flushing solution (22 ℃). The Mindray (T9) anesthesia monitor continuously monitors body temperature and whether shivers occur 30 minutes before treatment (T0), 30 minutes after anesthesia (T0), 60 minutes after surgery (T1), 120 minutes after surgery (T2), 180 minutes after surgery (T3), and after surgery (T4).

Intervention code：

组别：

对照组(C组)

样本量：

 48

Group：

Control group (Group C)

Sample size：

干预措施：

C组仅在穴位上贴电极片但不给予电刺激，但告诉受试者可能感受不到，记录治疗前后的体温变化。手环监测记录治疗当晚睡眠质量。

干预措施代码：

Intervention：

Group C only applied electrode patches to acupoints but did not receive electrical stimulation, but informed the subjects that they may not feel it and recorded the changes in body temperature before and after treatment. Monitor and record the sleep quality of the night of treatment with a wristband.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山西 

市(区县)：

 太原 

Country：

China

Province：

Shanxi

City：

Taiyuan

单位(医院)：

 中国人民解放军联勤保障部队第985医院 

单位级别：

 三甲 

Institution
hospital：

The 985th Hospital of the Joint Service Support Force of the People's Liberation Army

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术后低体温发生率

指标类型：

主要指标

Outcome：

Postoperative hypothermia incidence

Type：

Primary indicator

测量时间点：

手术结束

测量方法：

迈瑞（T9）麻醉监护仪连续监测腋下及鼻咽温

Measure time point of outcome：

End of surgery

Measure method：

Mindray (T9) anesthesia monitor continuously monitors axillary and nasopharyngeal temperature

指标中文名：

术后寒战发生率

指标类型：

主要指标

Outcome：

Postoperative shivering incidence

Type：

Primary indicator

测量时间点：

手术结束

测量方法：

固定一名麻醉医师观察清醒拔管后患者的寒战发生

Measure time point of outcome：

End of surgery

Measure method：

Fix an anesthesiologist to observe the occurrence of shivers in patients after conscious extubation

指标中文名：

术前、术中及清醒不同时间点体温

指标类型：

主要指标

Outcome：

Preoperative and intraoperative body temperature at different time points

Type：

Primary indicator

测量时间点：

治疗前30 min(T0)，麻醉后30min(T0)，手术后60min(T1)，手术后120min(T2)，手术后180min(T3)及手术结束后(T4)体温

测量方法：

迈瑞（T9）麻醉监护仪连续监测腋下及鼻咽温

Measure time point of outcome：

30 minutes before treatment (T0), 30 minutes after anesthesia (T0), 60 minutes after surgery (T1), 120 minutes after surgery (T2), 180 minutes after surgery (T3), and body temperature after surgery (T4)

Measure method：

Mindray (T9) anesthesia monitor continuously monitors axillary and nasopharyngeal temperature

指标中文名：

术前、术中及清醒不同时间点平均动脉压

指标类型：

次要指标

Outcome：

Mean arterial pressure at different time points before and during operation

Type：

Secondary indicator

测量时间点：

治疗前30 min(T0)，麻醉后30min(T0)，手术后60min(T1)，手术后120min(T2)，手术后180min(T3)及手术结束后(T4)体温

测量方法：

迈瑞（T9）麻醉监护仪

Measure time point of outcome：

30 minutes before treatment (T0), 30 minutes after anesthesia (T0), 60 minutes after surgery (T1), 120 minutes after surgery (T2), 180 minutes after surgery (T3), and after surgery (T4)

Measure method：

Mindray (T9) anesthesia monitor

指标中文名：

睡眠质量

指标类型：

次要指标

Outcome：

Sleep quality

Type：

Secondary indicator

测量时间点：

穴位治疗当晚入睡开始到清醒起床。包括：总睡眠时间，深睡眠时间，浅睡眠时间，清醒次数和清醒时间

测量方法：

睡眠手环监测记录仪

Measure time point of outcome：

Acupoint therapy starts from falling asleep that night until waking up. Including: total sleep time, deep sleep time, light sleep time, wakefulness frequency, and wakefulness time

Measure method：

Sleep bracelet monitoring recorder

指标中文名：

手术时间

指标类型：

次要指标

Outcome：

Operative time

Type：

Secondary indicator

测量时间点：

手术开始到结束时间

测量方法：

麦迪斯顿麻醉系统自动记录

Measure time point of outcome：

Surgery start to end time

Measure method：

Madison Anesthesia System Automatic Recording

指标中文名：

总输液量

指标类型：

次要指标

Outcome：

Total infusion volume

Type：

Secondary indicator

测量时间点：

进入手术室到离开手术室时间

测量方法：

巡回护士输液，麻醉医师记录麻醉单

Measure time point of outcome：

Time from entering the operating room to leaving the operating room

Measure method：

Patrol nurse infusion, anesthesiologist records anesthesia sheet

指标中文名：

腹腔冲洗液量

指标类型：

次要指标

Outcome：

Amount of peritoneal flushing fluid

Type：

Secondary indicator

测量时间点：

手术开始到结束时间

测量方法：

巡回护士负责准备（500ml/瓶），手术结束麻醉医师统计记录入麻醉单

Measure time point of outcome：

Surgery start to end time

Measure method：

The itinerant nurse is responsible for preparing, and the anesthesiologist records the anesthesia sheet

指标中文名：

局部皮肤过敏

指标类型：

副作用指标

Outcome：

Local skin allergies

Type：

Adverse events

测量时间点：

手术前一天及手术当日使用后

测量方法：

实验医师观察

Measure time point of outcome：

After use one day before and on the day of surgery

Measure method：

Observations by experimental physicians

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

N/A

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 36 岁 years
最大 Max age 70 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

按随机数字表法随机分为穴位治疗组和对照组，每组各48例。

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

Randomly divide into acupoint treatment group and control group according to the random number table method, with 48 cases in each group.

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：

治疗医师和患者以及数据收集回访医师不知分组情况。

Blinding：

Treatment physicians, patients, and data collection follow-up physicians do not know the grouping situation.

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

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）：

临床试验公共管理平台ResMan (http://www.medresman.org.cn/login.aspx)。

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

On December 30, 2024, the original data will be shared after the clinical research experiment. ResMan (http://www.medresman.org.cn/login.aspx).

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

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

CRF

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：

  2023-09-18 16:31:43
返回列表
欢迎访问WHO国际临床试验注册平台 Clinical Trials Hong Kong

中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

Copyright(c) (2005 - 2023) Chictr.org.cn.All rights reserved. 中国临床试验注册中心 版权所有

蜀ICP备16010396号-9

提示：推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统