今天是:2021-07-24 星期六

老年患者全身麻醉后苏醒期谵妄和术后谵妄的发生率、危险因素及对术后近、远期结局的影响:一项前瞻性队列研究
下载XML文档

注册号:

Registration number:

ChiCTR-OOC-17012734 

最近更新日期:

Date of Last Refreshed on:

2017-09-19 

注册时间:

Date of Registration:

2017-09-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

老年患者全身麻醉后苏醒期谵妄和术后谵妄的发生率、危险因素及对术后近、远期结局的影响:一项前瞻性队列研究 

Public title:

The incidence rate, risk factors and effects on near and long-term outcomes after surgery of delirium in the post-anaesthesia care unit and postoperative delirium in elderly patients after general anaesthesia:a prospective cohort study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

老年患者全身麻醉后苏醒期谵妄和术后谵妄的发生率、危险因素及对术后近、远期结局的影响:一项前瞻性队列研究 

Scientific title:

The incidence rate, risk factors and effects on near and long-term outcomes after surgery of delirium in the post-anaesthesia care unit and postoperative delirium in elderly patients after general anaesthesia:a prospective cohort 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:

聂彬 

研究负责人:

王东信 

Applicant:

Nie Bin 

Study leader:

Wang Dongxin 

申请注册联系人电话:

Applicant telephone:

+86 13960906936 

研究负责人电话:

Study leader's telephone:

+86 010 83575138 

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:

nie.bin99@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wangdongxin@hotmail.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:

福州市福马路马路顶91号 

研究负责人通讯地址:

北京市西什库大街8号 

Applicant address:

91 Maluding, Fengban, Fuma Road, Fuzhou, Fujian, China 

Study leader's address:

8 Xishiku street, Beijing, China 

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:

福建省肿瘤医院麻醉科 

Applicant's institution:

Department of Anesthesiology, Fujian Cancer Hospital 

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:

2017-1419 

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:

北京大学第一医院临床研究伦理委员会 

Name of the ethic committee:

Clinical research ethics committee of Peking University First Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2017-08-04 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

北京大学第一医院 

Primary sponsor:

Peking University First Hospital 

研究实施负责(组长)单位地址:

北京市西什库大街8号 

Primary sponsor's address:

8 Xishiku Street, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学第一医院

具体地址:

北京市西什库大街8号

Institution
hospital:

Peking University First Hospital

Address:

8 XIshiku Street, Beijing

经费或物资来源:

科室自筹 

Source(s) of funding:

Self-raised department 

研究疾病:

谵妄 

Target disease:

Delirium 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

观察全麻老年患者术后苏醒期谵妄和术后谵妄的发生率; 分析苏醒期谵妄与术后谵妄的危险因素; 比较苏醒期谵妄与术后谵妄对术后结局的影响。 

Objectives of Study:

Observe the incidence of delirium in the post-anaesthesia care unit and postoperative delirium in elderly patients after general anaesthesia analyze risk factors of delirium in the post-anaesthesia care unit and postoperative delirium compare effects on near and long-term outcomes after surgery of delirium in the post-anaesthesia care unit and postoperative delirium. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1 年龄≥65岁,<90岁; 2 全身麻醉下接受择期/限期手术,预期手术时间≥2h。 

Inclusion criteria

1. Elderly patients aged 60 to 90 years; 2. undergo non-emergency (>=2 hours) surgery under general anesthesia. 

排除标准:

1拒绝参加本研究; 2术前有精神分裂症、癫痫、帕金森症、重症肌无力; 3术前因昏迷、严重痴呆或语言障碍而无法交流; 4颅脑损伤或神经外科手术; 5 ASA分级≥IV 级患者。 

Exclusion criteria:

1. Refuse to participate in the study; 2. Diagnosed psychiatric disorders and neurological diseases such as epilepsy, Parkinson's Diseasemyasthenia gravis; 3. Severe dementia, comatose or logopathy patients unable to communicate; 4. Craniocerebral injury or neurosurgery; 5. ASA classification IV or above. 

研究实施时间:

Study execute time:

From2017-09-21To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2017-09-21To 2020-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

1000

Group:

Case series

Sample size:

干预措施:

全身麻醉后

干预措施代码:

Intervention:

after general anaesthesia

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学第一医院 

单位级别:

三甲 

Institution
hospital:

Peking University First Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

术后苏醒期谵妄的发生率

指标类型:

主要指标 

Outcome:

incidence of delirium in the post-anaesthesia care unit after surgery

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后五天谵妄的发生率

指标类型:

主要指标 

Outcome:

daily prevalence of postoperative delirium during the first 5 days after surgery

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

苏醒期躁动的发生情况

指标类型:

次要指标 

Outcome:

the degree of dysphoria during recovery

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3年存活时间

指标类型:

次要指标 

Outcome:

the survial duration within three years 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:

术后NRS疼痛评分(PACU期间及术后第1-5天)、NRS睡眠评分(术后第1-5天)

指标类型:

次要指标 

Outcome:

NRS pain score during PACU and postoperative days 1-5; NRS score of subjective sleep quality during postoperative days 1-5

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后住院时间

指标类型:

次要指标 

Outcome:

Length of stay in hospital 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:

术后30天内并发症发生率

指标类型:

次要指标 

Outcome:

Incidence of non-delirium complications with 30 days 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:

术后30天存活率

指标类型:

次要指标 

Outcome:

All-cause 30-day 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天存活病人生活质量评分

指标类型:

次要指标 

Outcome:

Quality of life of 30-day survivors: assessed with QOL-Bref

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天存活病人认知功能评分

指标类型:

次要指标 

Outcome:

Cognitive function of 30-day survivors: assessed with modified version of the TICS questionnaire

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后无复发存活时间(针对恶性肿瘤病人)

指标类型:

次要指标 

Outcome:

Duration of recurrence-free survival within after surgery (For patients with malignant tumors)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后无事件存活时间(针对全部病人,事件包括肿瘤复发转移、任何原因引起的住院、死亡等)

指标类型:

次要指标 

Outcome:

Duration of event-free survival within after surgery (For all patients,events include recurrence of the tumor, hospitalization or death caused by any cause)

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3年存活病人的生活质量评分

指标类型:

次要指标 

Outcome:

Quality of life in 1-3 years survivors after surgery (assessed with QOL-Bref)

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3年存活病人的认知功能TICS-m评分

指标类型:

次要指标 

Outcome:

Cognitive function in 1-3 years survivors after surgery (assessed with TICS-m)

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:

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 65 years
最大 Max age 90 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):

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

NO

盲法:

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

否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):

所有的数据在研究结束半年后公布以论文的形式公布

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

All research data will be shared at 6 months after end of study by thesis

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:

北京大学第一医院麻醉科负责数据保管

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

Peking university anesthesiology department will kept all research data

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2017-09-19
返回列表