ChiCTR2400085256 版本V1.0 版本创建时间2024/06/04 10:51:35 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：

 ChiCTR2400085256 

最近更新日期：

Date of Last Refreshed on：

 2024-06-04 10:51:27 

注册时间：

Date of Registration：

 2024-06-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

丙泊酚联合右美托咪定治疗慢性失眠患者疗效和安全性：一项前瞻性研究

Public title：

The efficacy and safety of propofol combined with dexmedetomidine in the treatment of chronic insomnia: a prospective study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

丙泊酚联合右美托咪定治疗慢性失眠患者疗效和安全性：一项前瞻性研究

Scientific title：

The efficacy and safety of propofol combined with dexmedetomidine in the treatment of chronic insomnia: a prospective 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：

车英杰 

研究负责人：

吴秀玲 

Applicant：

cheyingjie 

Study leader：

wuxiuling 

申请注册联系人电话：

Applicant telephone：

 +86 182 9907 2057

研究负责人电话：

Study leader's
telephone：

+86 182 9907 2057

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：

 751564366@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 751564366@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：

新疆石河子市人民医院麻醉科

研究负责人通讯地址：

新疆石河子市人民医院麻醉科

Applicant address：

Anesthesiology Department of Shihezi People's Hospital in Xinjiang

Study leader's address：

Anesthesiology Department of Shihezi People's Hospital in Xinjiang

申请注册联系人邮政编码：

Applicant postcode：

 832000

研究负责人邮政编码：

Study leader's postcode：

 832000

申请人所在单位：

新疆石河子市人民医院(石河子大学医学院第三附属医院)麻醉科

Applicant's institution：

Anesthesiology Department of Shihezi People's Hospital (Third Affiliated Hospital of Shihezi University School of Medicine) in Xinjiang

研究负责人所在单位：

新疆石河子市人民医院(石河子大学医学院第三附属医院)麻醉科

Affiliation of the Leader：

Anesthesiology Department of Shihezi People's Hospital (Third Affiliated Hospital of Shihezi University School of Medicine) in Xinjiang

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：

 伦理(科) 第(2023) 07 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：

石河子市人民医院临床研究伦理委员会

Name of the ethic committee：

Clinical Research Ethics Committee of Shihezi People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-05-08 00:00:00

伦理委员会联系人：

于海波

Contact Name of the ethic committee：

yuhaibo

伦理委员会联系地址：

新疆石河子市西一路南二路10号小区

Contact Address of the ethic committee：

No.10 West 1st Road South 2nd Road Community, Shihezi City, Xinjiang

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 182 9076 5225

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 610835880@qq.com

研究实施负责（组长）单位：

石河子市人民医院（石河子大学医学院第三附属医院）

Primary sponsor：

Shihezi People's Hospital (Third Affiliated Hospital of Shihezi University School of Medicine)

研究实施负责（组长）单位地址：

石河子市西一路南二路10号小区

Primary sponsor's address：

10 West 1st Road South 2nd Road Community, Shihezi City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

新疆维吾尔自治区

市(区县)：

石河子

Country：

china

Province：

Xinjiang Uygur Autonomous Region

City：

shihezi

单位(医院)：

石河子市人民医院

具体地址：

石河子市西一路南二路10 号小区

Institution
hospital：

Shihezi People's Hospital

Address：

10 West 1st Road South 2nd Road Community, Shihezi City

经费或物资来源：

由石河子市人民医院（石河子大学医学院第三附属医院）资助

Source(s) of funding：

Supported by the People's Hospital of Shihezi City (Third Affiliated Hospital of Shihezi University School of Medicine)

研究疾病：

慢性失眠  

Target disease：

chronic insomnia

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

单臂 

Study design：

Single arm 

研究目的：

运用丙泊酚联合右美托咪定复合星状神经节阻滞和失眠认知疗法治疗慢性失眠，评估患者近期和中期治疗效果和安全性。  

Objectives of Study：

Using propofol combined with dexmedetomidine combined with stellate ganglion block and insomnia cognitive therapy to treat chronic insomnia, evaluate the short-term and mid-term treatment efficacy and safety of patients.

药物成份或治疗方案详述：

该研究在石河子市人民医院神经内科睡眠障碍中心病房进行，收治慢性原发性失眠症患者40人，已取得医院伦理委员会及患者的书面知情同意。 方法 （1） 患者第一天治疗，首先填写失眠病史采集表、失眠严重程度指数量表、匹兹堡睡眠质量指数量表、躯体化症状自评量表、 Epworth嗜睡量表、焦虑自评量表、抑郁自评量表、超声引导下星状神经节阻滞知情同意书、睡眠障碍知情同意书。然后进行两侧星状神经节阻滞治疗（先打一侧，半小时后再打另一侧），再进行睡眠认知行为的治疗（讲课），患者带手环回家睡觉，客观记录患者睡眠情况，记录睡眠日记。 （2） 治疗第二天，一侧星状神经节阻滞治疗+丙泊酚右美托咪定治疗+睡眠认知行为的治疗（讲课），记录睡眠日记。 （3）治疗第三天，一侧星状神经节阻滞治疗+睡眠认知行为的治疗（讲课），记录睡眠日记。 （4）治疗第四天，一侧星状神经节阻滞治疗+丙泊酚右美托咪定治疗+睡眠认知行为的治疗（讲课），记录睡眠日记。 （5）治疗第五天，一侧星状神经节阻滞治疗+睡眠认知行为的治疗（讲课），记录睡眠日记。 （6）治疗第六天，一侧星状神经节阻滞治疗，患者带手环回家睡觉，客观记录患者睡眠情况，记录睡眠日记。 （7）治疗第七天，双侧星状神经节阻滞治疗（先打一侧，半小时后再打另一侧），记录睡眠日记，患者填写匹兹堡睡眠质量指数量表。 星状神经节阻滞治疗：使用0.8-1%利多卡因，一次注射剂量4-5ml。 丙泊酚联合右美托咪定治疗前禁食8h、禁饮4小时，持续床旁心电图、脉搏血氧饱和度、无创血压监测，建立静脉通道。治疗从21：00开始，静脉注射0.5-1.5mg/kg丙泊酚+右美托咪定0.5-1.0ug/kg,10min输注完毕开始诱导。然后调整剂量丙泊酚2-4mg/kg/h+0.2-0.7ug/kg/h维持2h，右美托咪定需提前30分钟停药，停药后等待患者自然苏醒，确定生命体征正常，撤去监测，患者禁食，自由入睡。 分别于治疗前、治疗7天后采用多导睡眠监测仪对患者睡眠过程进行客观监测。 分别于治疗前、治疗7天后，治疗1月后，治疗3月后，治疗6月后采用匹兹堡睡眠质量指数（PSQI）来评估主观睡眠质量。其中治疗7天后，治疗1月后，治疗3月后，治疗6月后通过电话或者问卷星评价患者治疗后睡眠质量。 观察记录麻醉治疗后患者的不良反应，比如恶心，头昏等。2.3观察指标 判定指标：临床疗效，睡眠恢复正常为治愈；睡眠时间有所增加、睡眠质量好转为有效；睡眠时间及睡眠质量未见改善为无效；其中，总有效率=（治愈例数+有效例数）/总例数*100%  

Description for medicine or protocol of treatment in detail：

This study was conducted in the Neurology Sleep Disorder Center Ward of Shihezi People's Hospital, treating 40 patients with chronic primary insomnia. Written informed consent from the hospital's ethics committee and patients has been obtained. Inclusion criteria: ① Meets the diagnostic criteria for chronic insomnia in the 2017 edition of the Chinese Guidelines for the Diagnosis and Treatment of Adult Insomnia. ② Before admission, patients received routine treatment in accordance with the 2017 edition of the Chinese Guidelines for the Diagnosis and Treatment of Adult Insomnia. There were more than two types of treatment drugs, and the treatment time exceeded 3 months. The treatment effect was poor or ineffective; Pittsburgh Sleep Quality Index (PSQI) score>9 before admission, diagnosed as chronic primary insomnia The patient voluntarily accepts this treatment and signs a written informed consent form, regardless of gender, aged between 18-70 years old. Exclusion criteria: Patients with sleep apnea syndrome, history of epilepsy, known alcohol or drug dependence, pregnant or breastfeeding. 2.2 Methods (1) On the first day of treatment, the patient first fills out the insomnia history collection form, insomnia severity index scale, Pittsburgh sleep quality index scale, and somatization symptom self-assessment scale Epworth Sleepiness Scale, Self Rating Anxiety Scale, Self Rating Depression Scale, Informed Consent Form for Ultrasound Guided Stellate Ganglion Block, and Informed Consent Form for Sleep Disorders. Then, bilateral stellate ganglion block treatment is performed (first on one side, half an hour later on the other side), followed by sleep cognitive behavior treatment (lecture). The patient takes a wristband home to sleep, objectively records the patient's sleep situation, and records a sleep diary. (2) On the second day of treatment, one side of the stellate ganglion block was treated with propofol dexmedetomidine and sleep cognitive behavior was treated (lecture), and a sleep diary was recorded. (3) On the third day of treatment, one side of the stellate ganglion block was treated with sleep cognitive behavior therapy (lecture), and a sleep diary was recorded. (4) On the the?fourth?day of treatment, unilateral stellate ganglion block treatment+propofol and dexmedetomidine treatment+sleep cognitive behavior treatment (lecture), and record sleep diary. (5) On the fifth day of treatment, one side of the stellate ganglion block was treated with sleep cognitive behavior therapy (lecture), and a sleep diary was recorded. (6) On the sixth day of treatment, one side of the stellate ganglion was blocked for treatment. The patient brought a wristband home to sleep, objectively recording the patient's sleep situation and keeping a sleep diary. (7) On the seventh day of treatment, bilateral stellate ganglion block therapy was performed (first on one side, half an hour later on the other side), and a sleep diary was recorded. The patient completed the Pittsburgh Sleep Quality Index scale. Stellate ganglion block treatment: Use 0.8-1% lidocaine, with a single injection volume of 4-5ml. Fasting for 8 hours and drinking for 4 hours before treatment with propofol combined with dexmedetomidine, continuous bedside electrocardiogram, pulse oxygen saturation, non-invasive blood pressure monitoring, and establishment of a venous channel. The treatment starts at 21:00, with intravenous injection of 0.5-1.5mg/kg propofol+dexmedetomidine 0.5-1.0ug/kg, and induction begins after 10 minutes of infusion. Then adjust the dose of propofol 2-4mg/kg/h+0.2-0.7ug/kg/h for 2h. Dextrmedetomidine needs to be stopped 30 minutes in advance. After stopping the drug, wait for the patient to wake up naturally, confirm that the vital signs are normal, withdraw the monitoring, and the patient fastes and falls asleep freely. Objectively monitor the patient's sleep process using a multi-channel sleep monitor before and 7 days after treatment. Subjective sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI) before treatment, 7 days after treatment, 1 month after treatment, 3 months after treatment, and 6 months after treatment. After 7 days of treatment, 1 month of treatment, 3 months of treatment, and 6 months of treatment, the patient's sleep quality after treatment was evaluated by phone or questionnaire. Observe and record the adverse reactions of patients after anesthesia treatment, such as nausea, dizziness, etc. 2.3 Observation indicators Judgment indicators: Clinical efficacy, recovery from normal sleep as cure; An increase in sleep time and improvement in sleep quality are effective; No improvement in sleep time and sleep quality is considered ineffective; Among them, the total effective rate=(number of cured cases+number of effective cases)/total number of cases * 100% 

纳入标准：

①符合《中国成人失眠诊断与治疗指南2017版》慢性失眠诊断标准。②患者入院前均按照《中国成人失眠诊断与治疗指南2017版》进行常规治疗，治疗药物超过两类，治疗时间超过3个月，治疗效果差或者无效；入院前匹兹堡睡眠质量指数（PSQI）评分>9分，诊断为慢性原发性失眠。③患者自愿采加本治疗，并签署书面知情同意书，性别不限，年龄在18-70岁。

Inclusion criteria

① Meets the diagnostic criteria for chronic insomnia in the 2017 edition of the Chinese Adult Insomnia Diagnosis and Treatment Guidelines Before admission, patients received routine treatment in accordance with the 2017 edition of the Chinese Guidelines for the Diagnosis and Treatment of Adult Insomnia. There were more than two types of treatment drugs, and the treatment time exceeded 3 months. The treatment effect was poor or ineffective; Pittsburgh Sleep Quality Index (PSQI) score>9 before admission, diagnosed as chronic primary insomnia The patient voluntarily accepts this treatment and signs a written informed consent form, regardless of gender, aged between 18-70 years old.

排除标准：

有睡眠呼吸暂停综合征，癫痫病史，已知酗酒或者药物依赖的患者，妊娠或哺乳的患者。

Exclusion criteria：

Patients with sleep apnea syndrome, history of epilepsy, known alcoholism or drug dependence, pregnant or breastfeeding.

研究实施时间：

Study execute time：

从 From 2024-06-08 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-06-10 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：

麻醉治疗后（试验组）

样本量：

 40

Group：

After anesthesia treatment (experimental group)

Sample size：

干预措施：

运用丙泊酚联合右美托咪定复合星状神经节阻滞和失眠认知疗法治疗慢性失眠

干预措施代码：

Intervention：

Application of propofol combined with dexmedetomidine combined with stellate ganglion block and insomnia cognitive therapy in the treatment of chronic insomnia

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 新疆维吾尔自治区 

市(区县)：

 石河子 

Country：

china

Province：

Xinjiang Uygur Autonomous Region

City：

shihezi

单位(医院)：

 石河子市人民医院 

单位级别：

 三甲 

Institution
hospital：

Shihezi People's Hospital

Level of the institution：

Class A tertiary hospital

测量指标：

Outcomes：

指标中文名：

治疗后，第二天治疗有效率

指标类型：

主要指标

Outcome：

After treatment, the effective rate of treatment on the second day

Type：

Primary indicator

测量时间点：

治疗后，第二天睡眠

测量方法：

多导睡眠监测仪和匹兹堡睡眠质量指数对患者睡眠障碍性质和症状进行评估，评价受试者治疗后，第二天治疗有效率。

Measure time point of outcome：

After treatment, sleep the next day

Measure method：

The multi-channel sleep monitor and Pittsburgh Sleep Quality Index evaluate the nature and symptoms of sleep disorders in patients, and evaluate the effectiveness of treatment on the second day after treatment.

指标中文名：

治疗结束，1月后治疗有效率

指标类型：

主要指标

Outcome：

End of treatment, effective treatment rate after 1 month

Type：

Primary indicator

测量时间点：

治疗结束1月后

测量方法：

匹兹堡睡眠质量指数对患者睡眠障碍性质和症状进行评估，评价受试者治疗结束，1月后治疗有效率。

Measure time point of outcome：

One month after the end of treatment

Measure method：

The Pittsburgh Sleep Quality Index evaluates the nature and symptoms of sleep disorders in patients, and evaluates the effectiveness of treatment after one month of treatment.

指标中文名：

治疗结束，3个月后治疗有效率

指标类型：

主要指标

Outcome：

End of treatment, effective treatment rate after 3 months

Type：

Primary indicator

测量时间点：

治疗结束3月后

测量方法：

匹兹堡睡眠质量指数对患者睡眠障碍性质和症状进行评估，评价受试者治疗结束，3月后治疗有效率。

Measure time point of outcome：

Three months after the end of treatment

Measure method：

The Pittsburgh Sleep Quality Index evaluates the nature and symptoms of sleep disorders in patients, and evaluates the effectiveness of treatment after 3 months of completion.

指标中文名：

治疗结束，6个月后治疗有效率

指标类型：

次要指标

Outcome：

End of treatment, effective treatment rate after 6 months

Type：

Secondary indicator

测量时间点：

治疗结束6个月后

测量方法：

匹兹堡睡眠质量指数对患者睡眠障碍性质和症状进行评估，评价受试者治疗结束，6月后治疗有效率。

Measure time point of outcome：

Six months after the end of treatment

Measure method：

The Pittsburgh Sleep Quality Index evaluates the nature and symptoms of sleep disorders in patients, and evaluates the effectiveness of treatment after 6 months of completion.

指标中文名：

治疗后，第二天匹斯堡睡眠质量指数评分较治疗前改善值

指标类型：

主要指标

Outcome：

After treatment, the improvement value of the Pittsburgh Sleep Quality Index score on the second day compared to before treatment

Type：

Primary indicator

测量时间点：

治疗后，第二天睡眠

测量方法：

采用匹兹堡睡眠质量指数（PSQI）量表对受试者治疗后，第二天的睡眠质量进行评估，评价受试者治疗结束后，PSQI评分较治疗前改善值。

Measure time point of outcome：

After treatment, sleep the next day

Measure method：

The Pittsburgh Sleep Quality Index (PSQI) was used to evaluate the sleep quality of the subjects on the second day after treatment, and to evaluate the improvement in PSQI scores compared to before treatment.

指标中文名：

治疗结束后1个月匹兹堡睡眠质量指数（PSQI）评分较治疗前改善值

指标类型：

主要指标

Outcome：

Improvement in Pittsburgh Sleep Quality Index (PSQI) score one month after treatment compared to before treatment

Type：

Primary indicator

测量时间点：

治疗后1个月

测量方法：

采用匹兹堡睡眠质量指数（PSQI）量表对受试者治疗后一个月的睡眠质量进行评估， PSQI评分较治疗前改善值。

Measure time point of outcome：

One month after treatment

Measure method：

Evaluate the sleep quality of participants one month after treatment using the Pittsburgh Sleep Quality Index (PSQI) scale, The improvement value of PSQI score compared to before treatment.

指标中文名：

治疗结束后3个月匹兹堡睡眠质量指数（PSQI）评分较治疗前改善值

指标类型：

主要指标

Outcome：

Improvement in Pittsburgh Sleep Quality Index (PSQI) score at 3 months after treatment compared to before treatment

Type：

Primary indicator

测量时间点：

治疗后3个月

测量方法：

采用匹兹堡睡眠质量指数（PSQI）量表对受试者治疗后3个月的睡眠质量进行评估， PSQI评分较治疗前改善值。

Measure time point of outcome：

3 months after treatment

Measure method：

The Pittsburgh Sleep Quality Index (PSQI) was used to evaluate the sleep quality of participants at 3 months after treatment, and the PSQI score improved compared to before treatment.

指标中文名：

治疗结束后6个月匹兹堡睡眠质量指数（PSQI）评分较治疗前改善值

指标类型：

次要指标

Outcome：

Improvement in Pittsburgh Sleep Quality Index (PSQI) score 6 months after treatment compared to before treatment

Type：

Secondary indicator

测量时间点：

治疗后6个月

测量方法：

采用匹兹堡睡眠质量指数（PSQI）量表对受试者治疗后6个月的睡眠质量进行评估， PSQI评分较治疗前改善值。

Measure time point of outcome：

6 months after treatment

Measure method：

The Pittsburgh Sleep Quality Index (PSQI) was used to evaluate the sleep quality of participants 6 months after treatment, and the PSQI score improved compared to before treatment.

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

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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 18 岁 years
最大 Max age 70 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）：

无

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

none

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：

无

Blinding：

none

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）：

2025年完成研究后会公开原始数据

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

After completing the research in 2025, the original data will be made public

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：

Case Record Form

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：

  2024-06-04 10:51:27