Today is 2022-01-28

Effects of intraoperative methylprednisolone and dexamethasone on the incidence and prognosis of postoperative nausea and vomiting in patients undergoing general anesthesia
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注册号:

Registration number:

ChiCTR2200055643 

最近更新日期:

Date of Last Refreshed on:

2022-01-15 

注册时间:

Date of Registration:

2022-01-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请于伦理委员会批准后才开始征募参试者,并与我们联系上传伦理批件。 术中使用甲强龙及地塞米松对全麻患者术后恶心呕吐发生率及预后的影响 

Public title:

Effects of intraoperative methylprednisolone and dexamethasone on the incidence and prognosis of postoperative nausea and vomiting in patients undergoing general anesthesia 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

术中使用甲强龙及地塞米松对全麻患者术后恶心呕吐发生率及预后的影响 

Scientific title:

Effects of intraoperative methylprednisolone and dexamethasone on the incidence and prognosis of postoperative nausea and vomiting in patients undergoing general anesthesia 

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:

毛佳丽 

研究负责人:

毛佳丽 

Applicant:

Mao Jiali 

Study leader:

MaoJiali 

申请注册联系人电话:

Applicant telephone:

+86 13865999759 

研究负责人电话:

Study leader's telephone:

+86 13865999759 

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:

shiningmao96@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

shiningmao96@sina.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:

安徽省合肥市庐阳区庐江路21号7栋507室 

研究负责人通讯地址:

安徽省合肥市庐江路17号中科大附一院麻醉科 

Applicant address:

21 Lujiang Road, Luyang District, Hefei, Anhui, China  

Study leader's address:

17 Lujiang Road, Luyang District, Hefei, Anhui, 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:

中国科学技术大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

中国科学技术大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China 

研究实施负责(组长)单位地址:

安徽省合肥市庐阳区庐江路17号 

Primary sponsor's address:

17 Lujiang Road, Luyang District, Hefei, Anhui, 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):

安徽省

市(区县):

合肥市

Country:

China

Province:

Anhui

City:

Hefei

单位(医院):

中国科学技术大学附属第一医院

具体地址:

安徽省合肥市庐阳区庐江路17号

Institution
hospital:

The First Affiliated Hospital of USTC

Address:

17 Lujiang Road, Luyang District, Hefei, Anhui, China

经费或物资来源:

自筹 

Source(s) of funding:

self-raised 

研究疾病:

全麻术后恶心呕吐 

Target disease:

PONV 

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:

I期临床试验 

Study phase:

研究目的:

本研究的目的是比较在全身麻醉手术期间,静脉使用甲强龙和地塞米松对患者术后恶心呕吐发生率的影响,探讨如何有效降低围术期PONV的发生率,提高患者麻醉满意度及改善预后。 

Objectives of Study:

The purpose of this study was to compare the effects of intravenous methylprednisolone and dexamethasone on the incidence of postoperative nausea and vomiting in patients during general anesthesia surgery, to investigate how to effectively reduce the incidence of PONV, improve patient satisfaction with anesthesia and improve prognosis. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

在全身麻醉下接受外科手术的成年患者(年龄超过18岁) 

Inclusion criteria

Adult patients (over 18 years of age) undergoing surgical procedures under general anesthesia 

排除标准:

孕妇,既往有糖尿病病史或者术前检查提示空腹血糖水平升高的患者,处于消化道溃疡活动期的患者,术前正在服用激素类药物的患者 

Exclusion criteria:

include: pregnant women, patients with a previous history of diabetes mellitus or whose preoperative tests indicate elevated fasting blood glucose levels, patients with active peptic ulcers, and patients who are taking hormonal medications prior to surgery 

研究实施时间:

Study execute time:

From2022-02-01To 2023-02-01 

征募观察对象时间:

Recruiting time:

From2022-01-10To 2022-04-01 

干预措施:

Interventions:

组别:

A组

样本量:

200

Group:

group A

Sample size:

干预措施:

麻醉诱导时静脉给予生理盐水2ml

干预措施代码:

Intervention:

2ml of saline was given intravenously during induction of anesthesia

Intervention code:

组别:

B组

样本量:

200

Group:

Group B

Sample size:

干预措施:

麻醉诱导时给予地塞米松

干预措施代码:

Intervention:

Dexamethasone given during induction of anesthesia

Intervention code:

组别:

C组

样本量:

200

Group:

GroupC

Sample size:

干预措施:

麻醉诱导时给予甲强龙

干预措施代码:

Intervention:

Methylprednisolone was given during induction of anesthesia

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

安徽省 

市(区县):

合肥市 

Country:

CHINA 

Province:

ANHUI 

City:

HEFEI 

单位(医院):

中国科学技术大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of USTC  

Level of the institution:

Grade IIIA 

测量指标:

Outcomes:

指标中文名:

全麻术后恶心呕吐发生率

指标类型:

主要指标 

Outcome:

Incidence of PONV

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

虚弱量表评分

指标类型:

次要指标 

Outcome:

FACIT-F SCALE

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹血糖水平

指标类型:

副作用指标 

Outcome:

Fasting blood glucose level

Type:

Adverse events 

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

计算机系统按照1:1:1的比例将所有受试者随机分配到三组中的一个。具体分组将装在在一个不透明的信封中,等麻醉诱导准备开始时,研究人员才打开该信封

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

Randomization was generated by computer-generated randomization software with an allocation ratio of 1:1:1. Before induction, one member of this study opened opaque envelopes containing group allocation.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

ResMan IPD can be shared within 6 months after the trail complete, http://www.medresman.org.cn.

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

ResMan IPD can be shared within 6 months after the trail complete, http://www.medresman.org.cn.

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:

采用病例记录表的方法进行数据采集和管理

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:

有/Yes

注册人:

Name of Registration:

 2022-01-15
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