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DEXMEDETOMIDINE ON ISOFLURANE INDUCED OXIDATIVE STRESS AND DNA DAMAGE IN SURGERY
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注册号：

Registration number：

 ChiCTR2100055056 

最近更新日期：

Date of Last Refreshed on：

 2023-01-08 19:24:10 

注册时间：

Date of Registration：

 2021-12-31 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

DEXMEDETOMIDINE ON ISOFLURANE INDUCED OXIDATIVE STRESS AND DNA DAMAGE IN SURGERY

Public title：

DEXMEDETOMIDINE ON ISOFLURANE INDUCED OXIDATIVE STRESS AND DNA DAMAGE IN SURGERY

注册题目简写：

English Acronym：

研究课题的正式科学名称：

IMPACT OF DEXMEDETOMIDINE INFUSION ON ISOFLURANE INDUCED OXIDATIVE STRESS AND DNA DAMAGE IN PATIENTS UNDERGOING MAJOR EMERGENCY SURGERY

Scientific title：

IMPACT OF DEXMEDETOMIDINE INFUSION ON ISOFLURANE INDUCED OXIDATIVE STRESS AND DNA DAMAGE IN PATIENTS UNDERGOING MAJOR EMERGENCY SURGERY

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：

Sadaf Aroosa 

研究负责人：

Dr. Adeel Sattar 

Applicant：

Sadaf Aroosa 

Study leader：

Dr. Adeel Sattar 

申请注册联系人电话：

Applicant telephone：

 03354228844

研究负责人电话：

Study leader's
telephone：

03007218004

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：

 sadafaroosa10@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 adeel.sattar@uvas.edu.pk

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：

Outfall road lahore, Pakistan.

研究负责人通讯地址：

Outfall road, Data Gung Buksh town, Lahore, Pakistan

Applicant address：

Outfall road lahore, Pakistan.

Study leader's address：

Outfall road, Data Gung Buksh town, Lahore, Pakistan

申请注册联系人邮政编码：

Applicant postcode：

 54000

研究负责人邮政编码：

Study leader's postcode：

 54000

申请人所在单位：

巴基斯坦University of veterinary and animal sciences

Applicant's institution：

University of veterinary and animal sciences, Lahore, Pakistan

研究负责人所在单位：

巴基斯坦University of veterinary and animal sciences

Affiliation of the Leader：

University of veterinary and animal sciences

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：

 ANS-6466

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：

postgraduate medical institute, Ameer ud din medical college, Lahore general hospital.

Name of the ethic committee：

postgraduate medical institute, Ameer ud din medical college, Lahore general hospital.

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-02-18 00:00:00

伦理委员会联系人：

prof. Dr, Jodat Saleem

Contact Name of the ethic committee：

prof. Dr, Jodat Saleem

伦理委员会联系地址：

postgraduate medical institute, Ameer ud din medical college, Lahore general hospital.

Contact Address of the ethic committee：

postgraduate medical institute, Ameer ud din medical college, Lahore general hospital.

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：

University of veterinary and animal sciences, Lahore, Pakistan

Primary sponsor：

University of veterinary and animal sciences, Lahore, Pakistan

研究实施负责（组长）单位地址：

Outfall road, Data Gung Buksh town, Lahore

Primary sponsor's address：

Outfall road, Data Gung Buksh town, Lahore

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

University of veterinary and animal sciences, Lahore, Pakistan

Source(s) of funding：

University of veterinary and animal sciences, Lahore, Pakistan

研究疾病：

oxidative stress and DNA Damage  

Target disease：

oxidative stress and DNA Damage

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The aims and objectives of proposed research work is: To evaluate the oxidative stress and DNA damage induced by Isoflurane. To study the effect of Dexmedetomidine infusion on Isoflurane induced oxidative stress and DNA damage in patients undergoing major invasive surgery.  

Objectives of Study：

The aims and objectives of proposed research work is: To evaluate the oxidative stress and DNA damage induced by Isoflurane. To study the effect of Dexmedetomidine infusion on Isoflurane induced oxidative stress and DNA damage in patients undergoing major invasive surgery.

药物成份或治疗方案详述：

After signing the informed consent and institutional ethical committee approval, 12 patients will be randomized into two groups namely Group A and Group B having6 patients in each group, respectively. The group A will receive Isoflurane while group B will receive Dexmedetomidine infusion along with Isoflurane as sedative agents, excluding the use of opioids. All the samples will be collected from Lahore General Hospital Lahore after hospital ethical committee approval. 

Description for medicine or protocol of treatment in detail：

After signing the informed consent and institutional ethical committee approval, 12 patients will be randomized into two groups namely Group A and Group B having6 patients in each group, respectively. The group A will receive Isoflurane while group B will receive Dexmedetomidine infusion along with Isoflurane as sedative agents, excluding the use of opioids. All the samples will be collected from Lahore General Hospital Lahore after hospital ethical committee approval. 

纳入标准：

Inclusion criteria

排除标准：

Diabetics, Overweight individuals, those with recently intake of antioxidant supplements or any medication, those who received radiation recently and elderly patients with decreased intravascular volume as they are prone to hypotension, will be excluded from the study.

Exclusion criteria：

Diabetics, Overweight individuals, those with recently intake of antioxidant supplements or any medication, those who received radiation recently and elderly patients with decreased intravascular volume as they are prone to hypotension, will be excluded from the study.

研究实施时间：

Study execute time：

从 From 2020-03-03 00:00:00至 To 2022-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-04-14 00:00:00 至 To 2022-03-31 00:00:00

干预措施：

Interventions：

组别：

A

样本量：

 6

Group：

A

Sample size：

干预措施：

Isoflurane alone

干预措施代码：

Intervention：

Isoflurane alone

Intervention code：

组别：

B

样本量：

 6

Group：

B

Sample size：

干预措施：

Isoflurane and Dexmedetomidine infusion

干预措施代码：

Intervention：

Isoflurane and Dexmedetomidine infusion

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 巴基斯坦

省(直辖市)：

 旁遮普 

市(区县)：

 拉合尔 

Country：

Pakistan

Province：

punjab

City：

Lahore

单位(医院)：

 Lahore General Hospital 

单位级别：

 postgraduate medical institution 

Institution
hospital：

Lahore General Hospital

Level of the institution：

postgraduate medical institution

测量指标：

Outcomes：

指标中文名：

If Dexmedetomidine is having antioxidant activity, lower level of oxidative stress and DNA damage by the use of Dexmedetomidine infusion with Isoflurane for maintainance of anaethesia will be helpful to overcome these problems during surgery.

指标类型：

主要指标

Outcome：

If Dexmedetomidine is having antioxidant activity, lower level of oxidative stress and DNA damage by the use of Dexmedetomidine infusion with Isoflurane for maintainance of anaethesia will be helpful to overcome these problems during surgery.

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：

Blood

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 岁 years
最大 Max age 50 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）：

patients were randomly selected by Anesthetist for 2 different protocol of general anesthesia.

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

patients were randomly selected by Anesthetist for 2 different protocol of general anesthesia.

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：

Not stated

Blinding：

Not stated

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）：

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：

data will be collected manually, electronic images will be taken through fluorescent microscope in case of DNA damage test. Data will be analyzed by statistical software.

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

data will be collected manually, electronic images will be taken through fluorescent microscope in case of DNA damage test. Data will be analyzed by statistical software.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-12-31 05:56:29
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