Today is 2019-12-07

Evaluation of Nitrous Oxide In the Gas Mixture for Anesthesia: A Randomized Controlled Trial for the Prevention of Chronic Pain After Major Abdominal Surgery
download

注册号:

Registration number:

ChiCTR-TRC-14004470 

最近更新日期:

Date of Last Refreshed on:

2016-08-28 

注册时间:

Date of Registration:

2014-04-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

麻醉時使用氧化亞氮的隨機對照研究:一項預防腹部大手術後慢性疼痛发生的研究 

Public title:

Evaluation of Nitrous Oxide In the Gas Mixture for Anesthesia: A Randomized Controlled Trial for the Prevention of Chronic Pain After Major Abdominal Surgery 

注册题目简写:

 

English Acronym:

ENIGMA Pain 

研究课题的正式科学名称:

麻醉時使用氧化亞氮的隨機對照研究:一項預防腹部大手術後慢性疼痛发生的研究 

Scientific title:

Evaluation of Nitrous Oxide In the Gas Mixture for Anesthesia: A Randomized Controlled Trial for the Prevention of Chronic Pain After Major Abdominal Surgery 

研究课题代号(代码):

Study subject ID:

CRE-2011.495-T 

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:

CUHK_CCT00402 

申请注册联系人:

Matthew Chan 

研究负责人:

Matthew Chan 

Applicant:

Matthew Chan 

Study leader:

Matthew Chan 

申请注册联系人电话:

Applicant telephone:

+86 2632 2736 

研究负责人电话:

Study leader's telephone:

+86 2632 2736 

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:

mtvchan@cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

mtvchan@cuhk.edu.hk 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/241 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/241 

申请注册联系人通讯地址:

Department of Anaesthesia and Intensive Care, 4/F Main Clinical BLock and Trauma Center, Prince of Wales Hospital, Shatin, Hong Kong 

研究负责人通讯地址:

Department of Anaesthesia and Intensive Care, 4/F Main Clinical BLock and Trauma Center, Prince of Wales Hospital, Shatin, Hong Kong 

Applicant address:

Department of Anaesthesia and Intensive Care, 4/F Main Clinical BLock and Trauma Center, Prince of Wales Hospital, Shatin, Hong Kong 

Study leader's address:

Department of Anaesthesia and Intensive Care, 4/F Main Clinical BLock and Trauma Center, Prince of Wales Hospital, Shatin, Hong Kong 

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:

The Chinese University of Hong Kong 

Applicant's institution:

The Chinese University of Hong Kong 

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:

NA 

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:

The Chinese University of Hong Kong 

Name of the ethic committee:

The Chinese University of Hong Kong 

伦理委员会批准日期:

Date of approved by ethic committee:

2011-12-06 

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:

The Chinese University of Hong Kong 

Primary sponsor:

The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

The Chinese University of Hong Kong 

Primary sponsor's address:

The Chinese University of Hong Kong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中國

省(直辖市):

香港特別行政區

市(区县):

Country:

China

Province:

Hong Kong SAR

City:

单位(医院):

The Chinese University of Hong Kong

具体地址:

The Chinese University of Hong Kong

Institution
hospital:

The Chinese University of Hong Kong

Address:

The Chinese University of Hong Kong

经费或物资来源:

Health and Medical research Fund 

Source(s) of funding:

Health and Medical research Fund 

研究疾病:

慢性疼痛 

Target disease:

Chronic pain 

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:

麻醉時使用氧化亞氮預防腹部大手術後慢性疼痛发生 

Objectives of Study:

Evaluation of Nitrous Oxide In the Gas Mixture for Anesthesia for the Prevention of Chronic Pain After Major Abdominal Surgery. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1) men or women aged ≥18 years; (2) American Society of Anesthesiologists physical status class 1-3; (3) major elective (open or laparoscopic) abdominal surgery, with an abdominal incision of at least 10 cm. 

Inclusion criteria

(1) men or women aged ≥18 years; (2) American Society of Anesthesiologists physical status class 1-3; (3) major elective (open or laparoscopic) abdominal surgery, with an abdominal incision of at least 10 cm. 

排除标准:

(1) acute bowel obstruction (contraindicated for N2O administration); (2) marked impairment of gaseous exchange (usually due to severe chronic obstructive pulmonary disease, requiring inspired O2 concentration >40%); (3) patients who plan to have a regional block for perioperative analgesia; (4) patients who are taking daily doses of opioids, tramadol, ketamine, gabanoids, tricyclic antidepressants, neuroleptics, serotonin reuptake inhibitors, COX2 inhibitors or other non-steroidal anti-inflammatory drugs 7 days before surgery; (5) atients who are not expected to be available for, or to cooperate with, interviews and those who refuse consent or who previously enrolled in the study. 

Exclusion criteria:

(1) acute bowel obstruction (contraindicated for N2O administration); (2) marked impairment of gaseous exchange (usually due to severe chronic obstructive pulmonary disease, requiring inspired O2 concentration >40%); (3) patients who plan to have a regional block for perioperative analgesia; (4) patients who are taking daily doses of opioids, tramadol, ketamine, gabanoids, tricyclic antidepressants, neuroleptics, serotonin reuptake inhibitors, COX2 inhibitors or other non-steroidal anti-inflammatory drugs 7 days before surgery; (5) atients who are not expected to be available for, or to cooperate with, interviews and those who refuse consent or who previously enrolled in the study. 

研究实施时间:

Study execute time:

From2014-04-18To  

干预措施:

Interventions:

组别:

Two groups

样本量:

800

Group:

Two groups

Sample size:

干预措施:

Nitrous oxide versus 30%oxygen in air

干预措施代码:

Intervention:

Nitrous oxide versus 30%oxygen in air

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

香港特別行政區 

市(区县):

 

Country:

China 

Province:

Hong Kong SAR 

City:

 

单位(医院):

The Chinese University of Hong Kong 

单位级别:

The Chinese University of Hong Kong 

Institution
hospital:

The Chinese University of Hong Kong  

Level of the institution:

The Chinese University of Hong Kong 

测量指标:

Outcomes:

指标中文名:

Severe pain over the surgical site

指标类型:

主要指标 

Outcome:

Severe pain over the surgical site

Type:

Primary indicator 

测量时间点:

at 6 months after surgery

测量方法:

Measure time point of outcome:

at 6 months after surgery

Measure method:

指标中文名:

Any pain over the surgical site lasting for 6 months after surgery.

指标类型:

次要指标 

Outcome:

Any pain over the surgical site lasting for 6 months 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:

Interference of chronic postsurgical pain with daily activities

指标类型:

次要指标 

Outcome:

Interference of chronic postsurgical pain with daily activities

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Impact of chronic postsurgical pain on general health status recorded by EQ-5D.

指标类型:

次要指标 

Outcome:

Impact of chronic postsurgical pain on general health status recorded by EQ-5D.

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 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):

Random

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

Random

盲法:

Blinding:

Double-blind

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-04-05
return list