依托咪酯麻醉对中性粒细胞免疫防御功能的影响

注册号:

Registration number:

ChiCTR2600123787 

最近更新日期:

Date of Last Refreshed on:

2026-04-29 17:28:15 

注册时间:

Date of Registration:

2026-04-29 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

依托咪酯麻醉对中性粒细胞免疫防御功能的影响

Public title:

Effect of etomidate anesthesia on the immune defense function of neutrophils

注册题目简写:

English Acronym:

研究课题的正式科学名称:

依托咪酯麻醉对中性粒细胞免疫防御功能的影响

Scientific title:

Effect of etomidate anesthesia on the immune defense function of neutrophils

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:

代和煜 

研究负责人:

王寿勇 

Applicant:

Heyu Dai 

Study leader:

Shouyong Wang 

申请注册联系人电话:

Applicant telephone:

+86 18081983336

研究负责人电话:

Study leader's
telephone:

+86 23 85381667

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:

858370608@qq.com

研究负责人电子邮件:

Study leader's E-mail:

wangshyong@126.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:

重庆市永川区宣花路439号

研究负责人通讯地址:

重庆市永川区宣花路439号

Applicant address:

No. 439, Xuanhua Road, Yongchuan District, Chongqing City

Study leader's address:

No. 439, Xuanhua Road, Yongchuan District, Chongqing City

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:

重庆医科大学附属永川医院

Applicant's institution:

Yongchuan Hospital Affiliated to Chongqing Medical University

研究负责人所在单位:

重庆医科大学附属永川医院

Affiliation of the Leader:

Yongchuan Hospital of Chongqing Medical University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2024EC0083

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:

重庆医科大学附属永川医院临床研究伦理审查委员会

Name of the ethic committee:

Clinical Research Ethics Committee ,Yongchuan Hospital of Chongqing Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2024-12-02 00:00:00

伦理委员会联系人:

唐宇

Contact Name of the ethic committee:

Yu Tang

伦理委员会联系地址:

重庆市永川区宣花路439号

Contact Address of the ethic committee:

No. 439, Xuanhua Road, Yongchuan District, Chongqing City

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 23 85381616

伦理委员会联系人邮箱:

Contact email of the ethic committee:

2992107908@qq.com

研究实施负责(组长)单位:

重庆医科大学附属永川医院

Primary sponsor:

Yongchuan Hospital of Chongqing Medical University

研究实施负责(组长)单位地址:

重庆市永川区宣花路439号

Primary sponsor's address:

No. 439, Xuanhua Road, Yongchuan District, Chongqing 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):

重庆市

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆医科大学附属永川医院

具体地址:

重庆市永川区宣花路439号

Institution
hospital:

Yongchuan Hospital of Chongqing Medical University

Address:

No. 439, Xuanhua Road, Yongchuan District, Chongqing City

经费或物资来源:

重庆医科大学附属永川医院院内课题

Source(s) of funding:

In-house Research Project of Yongchuan Hospital Affiliated to Chongqing Medical University

研究疾病:

术后与感染相关的并发症  

Target disease:

Postoperative infection-related complications

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:

上市后药物 

Study phase:

4

研究设计:

随机平行对照 

Study design:

Parallel 

研究目的:

本研究在于,探索依托咪酯是否可以直接抑制中性粒细胞的各项生理功能,进而增加患者术后感染相关并发症的发病率,并寻找解决办法,为患者加速术后康复,减少患者术后并发症提供新的思路。  

Objectives of Study:

This study aims to investigate whether etomidate directly inhibits various physiological functions of neutrophils, thereby increasing the incidence of postoperative infection-related complications in patients. It further seeks to identify solutions, offering novel approaches to accelerate postoperative recovery and reduce postoperative complications in patients.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1.合并免疫疾病或正在接受免疫治疗,正在接受放化疗的患者;
2.合并血液系统疾病或造血功能异常,中性粒细胞计数及占比异常;
3.恶性肿瘤患者;
4.存在明显全身或局部感染患者;
5.麻醉手术中需使用大剂量皮质激素的患者;

Exclusion criteria:

1.Patients with combined immune disorders or undergoing immunotherapy, or currently receiving radiotherapy and chemotherapy;
2.Concurrent haematological disorders or haematopoietic dysfunction, with abnormal neutrophil counts and percentage distribution;
3.malignant tumour patients;
4.Patients with evident systemic or localised infection;
5.Patients requiring high-dose corticosteroids during anaesthesia and surgery;

研究实施时间:

Study execute time:

From 2024-09-01 00:00:00 To 2026-07-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-09-01 00:00:00 To 2026-07-01 00:00:00

干预措施:

Interventions:

组别:

依托咪酯组

样本量:

15

Group:

Etoimidate Group

Sample size:

干预措施:

全身麻醉中,静脉麻醉药使用依托咪酯进行麻醉

干预措施代码:

Intervention:

During general anaesthesia, intravenous anaesthesia was administered using etomidate.

Intervention code:

组别:

丙泊酚组

样本量:

15

Group:

Propofol group

Sample size:

干预措施:

全身麻醉中,静脉麻醉药使用丙泊酚进行麻醉

干预措施代码:

Intervention:

During general anaesthesia, propofol is administered intravenously as the anaesthetic agent.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

重庆市 

市(区县):

 

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆医科大学附属永川医院 

单位级别:

三级甲等 

Institution
hospital:

Yongchuan Hospital of Chongqing Medical University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

吞噬功能

指标类型:

主要指标

Outcome:

Phagocytic function

Type:

Primary indicator

测量时间点:

术前、手术开始后2h

测量方法:

Measure time point of outcome:

Before surgery, and within 2 hours after the commencement of surgery

Measure method:

指标中文名:

脱颗粒功能

指标类型:

主要指标

Outcome:

degranulation functionreactive

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

活性氧生成

指标类型:

主要指标

Outcome:

oxygen species production

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胞外域脱落

指标类型:

主要指标

Outcome:

extracellular domain shedding

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:

血液

组织:

Sample Name:

Blood

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 years
最大 Max age 75 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):

采用随机数字表法,将患者分为两组,每组15例

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

Patients were randomly assigned to two groups using a random number table, with 15 patients 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:

不公开/Private

盲法:

对参试者设盲

Blinding:

Blinding of participants

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):

研究成果发表后6个月可通过通讯邮箱获取

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

Six months after the research publication via the corresponding e-mail

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:

电子采集和管理系统

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

Electronic Data Capture (EDC)

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2026-04-29 17:27:39