Register Now
Log In
中文/English
About ITMCTR|Search Trials|About Us
Effect of ear acupiont bean pressure on urinary catheter-related bladder irritation in male patients after general anesthesia

注册号：

Registration number：

ITMCTR2023000016

最近更新日期：

Date of Last Refreshed on：

2024-02-09

注册时间：

Date of Registration：

2023-06-14

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

耳穴压豆对全麻术后男性患者导尿管相关膀胱刺激征的影响

Public title：

Effect of ear acupiont bean pressure on urinary catheter-related bladder irritation in male patients after general anesthesia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

耳穴压豆对全麻术后男性患者导尿管相关膀胱刺激征的影响

Scientific title：

Effect of ear acupiont bean pressure on urinary catheter-related bladder irritation in male patients after general anesthesia

研究课题的正式科学名称简写：

Scientific title acronym：

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：

李思宇

研究负责人：

曾谷清

Applicant：

Siyu Li

Study leader：

Guqing Zeng

申请注册联系人电话：

Applicant telephone：

+86 182 1601 8392

研究负责人电话：

Study leader's telephone：

zengguqing0123@163.com

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：

951800845@qq.com

研究负责人电子邮件：

Study leader's E-mail：

zengguqing0123@163.com

申请单位网址(自愿提供)：

Study leader's 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：

湖南省衡阳市石鼓区船山大道69号

研究负责人通讯地址：

湖南省衡阳市蒸湘区常胜西路28号

Applicant address：

No. 69, Chuanshan Avenue, Shigu District, Hengyang City, Hunan Province

Study leader's address：

No. 28, Changsheng West Road, Zhengxiang District, Hengyang City, Hunan Province

申请注册联系人邮政编码：

Applicant postcode：

421001

研究负责人邮政编码：

Study leader's postcode：

421001

申请人所在单位：

南华大学附属第一医院

Applicant's institution：

The First Affiliated Hospital of the University of South China

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：

2023-USC-HL-71

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：

南华大学伦理委员会

Name of the ethic committee：

Ethics Committee, University of South China

伦理委员会批准日期：

Date of approved by ethic committee：

2023/3/17 0:00:00

伦理委员会联系人：

唐老师

Contact Name of the ethic committee：

Teacher Tang

伦理委员会联系地址：

湖南省衡阳市蒸湘区常胜西路28号

Contact Address of the ethic committee：

No. 28, Changsheng West Road, Zhengxiang District, Hengyang City, Hunan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 136 6754 9363

伦理委员会联系人邮箱：

Contact email of the ethic committee：

1139271625@qq.com

研究实施负责（组长）单位：

南华大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of the University of South China

研究实施负责（组长）单位地址：

湖南省衡阳市石鼓区船山大道69号

Primary sponsor's address：

No. 69, Chuanshan Avenue, Shigu District, Hengyang City, Hunan 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)：

湖南省

市(区县)：

衡阳市

Country：

China

Province：

Hunan Province

City：

Hengyang City

单位(医院)：

南华大学附属第一医院

具体地址：

湖南省衡阳市石鼓区船山路69号

Institution
hospital：

The First Affiliated Hospital of the University of South China

Address：

No. 69, Chuanshan Avenue, Shigu District, Hengyang City, Hunan Province

经费或物资来源：

湖南省自然科学基金

Source(s) of funding：

Hunan Provincial Natural Science Foundation

研究疾病：

导尿管相关膀胱刺激征

研究疾病代码：

Target disease：

catheter-related bladder irritation

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：

探讨耳穴压豆护理方法对全麻术后男性患者的应用效果，以期在防治导尿管相关膀胱刺激征方面为临床护理实践提供思路。

Objectives of Study：

To explore the nursing effect of Ear Acupoint Bean Pressing method on male patients after general anesthesia, in order to provide ideas for clinical nursing practice in the prevention and treatment of CRBD.

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）男性；（2）年龄 18 ~60 岁；（3）BMI 18 ~23. 9 kg /m2；（4）全身麻醉；非急诊手术；（5）无泌尿系统的现病史及既往史；（6）均在全麻诱导后留置导尿管；（7）美国麻醉医师协会（ASA）分级为Ⅰ-Ⅱ级；（8）无严重的心肺脑血管疾病；（9）无肝、肾等重要器官功能障碍；（10）签署知情同意书。

Inclusion criteria

(1) Male; (2) Age 18-60 years old; (3) BMI 18-23.9 kg /m2; (4) General anesthesia; Non-emergency surgery; (5) No history of present disease and past history of urinary system; (6) Indwelling catheters were placed after general anesthesia induction; (7) American Society of Anesthesiologists (ASA) grade I - II; (8) no serious cardiopulmonary and cerebrovascular diseases; (9) no dysfunction of vital organs such as liver and kidney; (10) Sign informed consent.

排除标准：

（1）在耳部选定穴位的皮肤区域出现皮疹或局部感染者；（2）既往有精神疾病；（3）认知功能障碍或沟通障碍；（4）三个月内有留置尿管史；（5）膀胱过度活跃症( 夜尿＞3次或24 h排尿次数＞8次)；（6）长期服用镇静剂及镇痛剂，酗酒或吸毒者。

Exclusion criteria：

(1) Rash or local infection occurs in the skin area of selected acupuncture points in the ear; (2) previous mental illness; (3) cognitive dysfunction or communication disorder; (4) History of indwelling urinary tube within three months; (5) Overactive bladder (nocturnal urination > 3 times or 24 h urination > 8 times); (6) Long-term use of sedatives and analgesics, alcohol or drug users.

研究实施时间：

Study execute time：

从From 2023-03-17

至To      2024-03-17

征募观察对象时间：

Recruiting time：

从From 2023-06-20

至To      2023-12-20

干预措施：

Interventions：

组别：

干预组

样本量：

60

Group：

Intervention group

Sample size：

干预措施：

①在中医科专家指导下，选取膀胱、肾俞、尿道、三焦、皮质下、神门、交感、心俞8个耳穴，由我科经同质化培训合格的专科护士进行操作。使用酒精对耳部皮肤消毒后，应用耳穴探棒寻找相应穴位，将王不留行籽固定于所选的穴位，采用点压法、对压法及直压法按压穴位，以患者感到酸、胀、麻、痛等为度，同时以患者耳部皮肤有红晕、感觉烘热、耐受为宜，5min/次,然后更换另一侧耳实施操作。②在对照组的基础上，耳穴压豆组患者于术前30min选定穴位后开始第一次干预，入复苏室后5min内进行第二次干预，苏醒后6h进行第三次干预，此后每6-8h干预一次，直至尿管拔除24h。

干预措施代码：

Intervention：

① Under the guidance of experts in Traditional Chinese medicine, 8 auricular points of bladder, Shenshu, urethra, Sanjiao, cortical, Shenmen, sympathetic and Xinshu were selected and operated by qualified nurses in our department after homogenization training. After the ear skin was disinfected with alcohol, the ear point probing stick was applied to find the corresponding acupoints, and the King's seeds were fixed at the selected acupoints. The acupoints were pressed by point pressure method, counterpressure method and direct pressure method. The patient felt acid, distension, numbness, pain, etc. as the degree, and the patient's ear skin was flushed, felt hot, and tolerance was appropriate, 5min/ time, and then the other ear was replaced for operation. ② On the basis of the control group, the patients in the auricular point pressure bean group started the first intervention 30 minutes before surgery after the selected points, the second intervention was performed within 5 minutes after entering the resuscitation room, the third intervention was performed 6 hours after awakening, and the intervention was performed every 6-8 hours until the urinary tube was removed for 24 hours.

Intervention code：

组别：

对照组

样本量：

60

Group：

Control group

Sample size：

干预措施：

①所有患者在术前一天接受访视，评估患者的麻醉分级及全身情况，并予以常规手术及麻醉相关健康指导，并予以答疑解惑及心理疏导。②入手术室后常规监测血压、心电图、血氧饱和度、呼末二氧化碳，开放静脉通路，予复方氯化钠静滴。所有患者全凭静脉给药予以实施麻醉诱导及麻醉维持，麻醉诱导用药均选用舒芬太尼0.5ug/kg、通过咪达唑仑0.05 mg/kg、丙泊酚2.5mg/kg、罗库溴铵0.6mg/kg，麻醉维持用药均选用瑞芬太尼0.1~0.3ug/kg/min、丙泊酚4~6mg/kg/h、罗库溴铵0.3~0.4mg/kg/h ；③所有患者均全凭静脉给药予以实施麻醉诱导及麻醉维持，麻醉诱导用药均选用舒芬太尼0.5ug/kg、丙泊酚2.5mg/kg、罗库溴铵0.6mg/kg，麻醉维持用药均选用瑞芬太尼0.1~0.3ug/kg/min、丙泊酚4~6mg/kg/h、罗库溴铵0.3~0.4mg/kg/h；④均在全身麻醉诱导后实施导尿管留置操作，根据患者尿道大小选择合适型号的双腔气囊乳胶导尿管；⑤导尿管留置操作均由经过同质化培训的经验丰富的手术室护士严格在无菌要求下完成，同时要求操作时将尿管全部插入后再往气囊内注入生理盐水10ml+5ml空气固定；⑥手术结束时停用麻醉药物，术后送入麻醉复苏室留观。入复苏室后予以常监测生命体征及病情变化，待患者自主呼吸恢复，肌力恢复，能执行指令动作时拔除气管导管。⑦如患者术后出现中重度导尿管相关膀胱刺激征则由麻醉医生根据情况予以曲马多1mg/kg对症处理；寒战时由麻醉医生根据情况予以曲马多1mg/kg对症处理；中重度疼痛则麻醉医生根据情况予以芬太尼1ug/kg对症处理，如果患者同时主诉中重度导尿管相关膀胱刺激征和术后疼痛，则根据更显著的主诉给予曲马多或芬太尼。⑧所有患者均在麻醉苏醒后24h内根据患者恢复情况及医生建议，由经过同质化培训的研究人员拔除尿管，要求抽尽气囊内生理盐水后，动作轻柔缓慢地拔除尿管。

干预措施代码：

Intervention：

① All patients were interviewed on the day before the operation to evaluate the anesthesia grade and general condition of the patients, and to give routine surgery and anesthesia related health guidance, and to answer questions and psychological counseling. ② After entering the operating room, blood pressure, electrocardiogram, blood oxygen saturation, and end-expiratory carbon dioxide were routinely monitored, and intravenous access was opened and compound sodium chloride was administered. All patients were given anesthesia induction and maintenance by intravenous administration. Sufentanil 0.5ug/kg, midazolam 0.05mg /kg, propofol 2.5mg/kg, rocuronium 0.6mg/kg were selected as anesthetic induction drugs. Remifentanil 0.1~0.3ug/kg/min, propofol 4~6mg/kg/h, rocuronium 0.3~0.4mg/kg/h were selected for anesthesia maintenance. ③ All patients were given anesthesia induction and maintenance by intravenous administration. Sufentanil 0.5ug/kg, propofol 2.5mg/kg, rocuronium 0.6mg/kg were selected as anesthetic induction drugs. Remifentanil 0.1~0.3ug/kg/min, propofol 4~6mg/kg/h, rocuronium 0.3~0.4mg/kg/h were selected for anesthesia maintenance. (4) Catheter indwelling operation was performed after induction of general anesthesia, and the suitable type of double-cavity balloon latex catheter was selected according to the size of the urethra of the patients; (5) Catheter indwelling operations are performed strictly under sterility requirements by experienced operating room nurses with homogenization training. At the same time, it is required to insert all urinary tubes and then inject 10ml of normal saline +5ml of air into the balloon for fixation; (6) Anesthesia drugs were discontinued at the end of the operation and sent to the anesthesia resuscitation room for observation. After entering the resuscitation room, the vital signs and condition changes should be monitored frequently, and the tracheal catheter should be removed when the patient's spontaneous breathing and muscle strength recovered and could execute the ordered actions. ⑦ If the patient has moderate to severe urinary catheter-related bladder irritation after surgery, the anesthesiologist will give tramadol 1mg/kg symptomatic treatment according to the situation; When shivering, the anesthesiologist should give tramadol 1mg/kg symptomatic treatment according to the situation; For moderate to severe pain, the anesthesiologist will give fentanyl 1ug/kg symptomatic treatment according to the circumstances. If the patient complains of moderate to severe catheter-related bladder irritation and postoperative pain at the same time, tramadol or fentanyl will be given according to the more significant complaints. In all patients, the urinary tube was removed within 24h after anesthesia according to the patient's recovery condition and the doctor's advice, and the urinary tube was removed gently and slowly after the normal saline in the air sac was drained.

Intervention code：

样本总量 Total sample size ： 120

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

湖南省

市(区县)：

衡阳市

Country：

China

Province：

Hunan Province

City：

Hengyang City

单位(医院)：

南华大学附属第一医院

单位级别：

三甲

Institution/hospital：

The First Affiliated Hospital of the University of South China

Level of the institution：

Tertiary A hospital

测量指标：

Outcomes：

指标中文名：

比较两组患者术后各时间点的血流动力学指标，包括平均动脉压MAP、心率HR、血氧饱和度SPO2

指标类型：

次要指标

Outcome：

The hemodynamic indexes, including mean arterial pressure MAP, heart rate HR and blood oxygen saturation SPO2, were compared between the two groups at each time point after surgery

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

比较2组患者拔除尿管后次日晨尿时的膀胱功能（平均尿流率及最大尿流率）。

指标类型：

次要指标

Outcome：

The bladder function (mean urine flow rate and maximum urine flow rate) of the two groups were compared the next morning after catheter removal.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

膀胱刺激征发生率及严重程度

指标类型：

主要指标

Outcome：

Incidence and severity of bladder irritation

Type：

Primary indicator

测量时间点：

麻醉苏醒拔除气管导管后即刻( T0 ) 、1 h( T1 ) 、2 h( T2 )、6h（T3）

测量方法：

Measure time point of outcome：

Anesthesia recovery Immediately after tracheal catheter removal (T0), 1 h(T1), 2 h(T2), 6h (T3)

Measure method：

指标中文名：

比较2组患者对围术期的整体满意度。

指标类型：

次要指标

Outcome：

The overall satisfaction of the two groups in perioperative period was compared.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

比较两组患者的一般苏醒质量指标。包括苏醒时长、疼痛、寒战、恶心呕吐等

指标类型：

次要指标

Outcome：

The general recovery quality indexes were compared between the two groups. Including waking time, pain, chills, nausea and vomiting.

Type：

Secondary 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：

尿液标本

组织：

Sample Name：

urine specimen

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：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 60 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男性

Male

随机方法（请说明由何人用什么方法产生随机序列）：

由项目负责人应用随机数字表法产生随机序列进行随机分组

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

The project leader uses the random number table method to generate random sequences for random grouping

盲法：

Blinding：

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）：

投稿时公开

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

Disclosure at the time of submission

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：

患者基本病情资料查阅电子病历系统；其余资料通过调查问卷及相关评估表当场登记收回；数据由双人录入、双人核对。

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

Access the basic condition information of the patient to the electronic medical record system; The remaining information was collected on the spot through questionnaires and related assessment forms; Data is entered by two people and checked by two people.

数据管理委员会：

Data Managemen Committee：

有

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):

back
Platform information
About ITMCTR
About Us
Register Trials
Frequently Asked Questions
Ethical Review
The public service
Search Trials
Join Us
ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above