今天是:2022-08-12 星期五

请与我们联系上传伦理批件。 支撑喉镜声带息肉切除术无肌松药插管全麻的可行性及安全性的临床研究
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注册号:

Registration number:

ChiCTR2200061868 

最近更新日期:

Date of Last Refreshed on:

2022-07-05 

注册时间:

Date of Registration:

2022-07-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请与我们联系上传伦理批件。 支撑喉镜声带息肉切除术无肌松药插管全麻的可行性及安全性的临床研究 

Public title:

Effectiveness and safety of intubation without muscle relaxation for vocal polyp resection with suspension laryngoscope 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

支撑喉镜声带息肉切除术无肌松药插管全麻的可行性及安全性的临床研究 

Scientific title:

Effectiveness and safety of intubation without muscle relaxation for vocal polyp resection with suspension laryngoscope:a randomized controlled trial 

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:

廖敏 

研究负责人:

廖敏 

Applicant:

Liao Min 

Study leader:

Liao Min 

申请注册联系人电话:

Applicant telephone:

13672470820 

研究负责人电话:

Study leader's telephone:

13672470820 

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:

liaomin23@aliyun.com 

研究负责人电子邮件:

Study leader's E-mail:

liaomin23@aliyun.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:

广东省广州市越秀区大德路111号 

研究负责人通讯地址:

广东省广州市越秀区大德路111号 

Applicant address:

111 Dade Road, Yuexiu District, Guangzhou , Guangdong Province, China 

Study leader's address:

111 Dade Road, Yuexiu District, Guangzhou , Guangdong Province, 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:

广东省中医院 

Applicant's institution:

Guangdong Provincial Hospital of Chinese Medicine 

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:

ZF2022-155-01 

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:

广东省中医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2022-06-08 

伦理委员会联系人:

李晓彦 

Contact Name of the ethic committee:

Li Xiaoyan 

伦理委员会联系地址:

广东省广州市越秀区大德路111号 

Contact Address of the ethic committee:

111 Dade Road, Yuexiu District, Guangzhou , Guangdong Province, China 

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:

广东省中医院 

Primary sponsor:

Guangdong Provincial Hospital of Chinese Medicine 

研究实施负责(组长)单位地址:

广东省中医院 

Primary sponsor's address:

Guangdong Provincial Hospital of Chinese Medicine 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong Province

City:

Guangzhou

单位(医院):

广东省中医院

具体地址:

广东省广州市越秀区大德路111号

Institution
hospital:

Guangdong Provincial Hospital of Chinese Medicine

Address:

111 Dade Road, Yuexiu District, Guangzhou , Guangdong Province, China

经费或物资来源:

自筹 

Source(s) of funding:

self-raised 

研究疾病:

声带息肉 

Target disease:

vocal polyp 

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:

探索性研究/预试验 

Study phase:

研究目的:

探讨在支撑喉镜CO2激光声带息肉切除术中,无肌松药插管全麻复合2%利多卡因表麻的可行性和安全性,术中生命体征、术中应激反应、麻醉恢复质量 

Objectives of Study:

The objective of the study is to examine the feasibility and safety of general anesthesia without muscle relaxant intubation combined with 2% lidocaine surface anesthesia in carbon dioxide laser vocal cord polypectomy with suspension laryngoscope, intraoperative vital signs, intraoperative stress response and anesthesia recovery quality 

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.择期行支撑喉镜CO2激光声带息肉切除术,性别不限;2.年龄18-65岁;3.体重指数:18.5-28kg/m2;4.无严重全身性系统性疾病;5. 无相关药物过敏史;6.气道 Mallampati分级 I-II 级。 

Inclusion criteria

1. Scheduling for elective Vocal cord polypectomy with CO2 laser suspension laryngoscope , regardless of gender; 2. Age 18-65; 3. Body mass index: 18.5-28kg/m2; 4. Class I or II physical status according to the American Society of Anesthesiologists (ASA); 5. No history of drug allergy; 6. Airway Mallampati grade I-II. 

排除标准:

1.精神疾病患者,;2.神经肌肉系统疾病、ASA分级III-IV级;3.气道高反应、慢性阻塞性肺疾病史;4.怀疑困难气道;5.牙齿松动;6. 其它声带疾病,如声门癌、声带白斑、雷式水肿、声带瘢痕、肉芽肿 ;7. 药物滥用史;8. 妊娠及哺乳期妇女。 

Exclusion criteria:

1. Patients with mental illness; 2. Neuromuscular diseases, ASA grade III-IV; 3. Airway hyperresponsiveness and chronic obstructive pulmonary disease; 4. Suspected difficult airway;5. Loose teeth; 6. Other vocal cord diseases, such as glottic carcinoma, vocal cord leukoploma, thunder edema, vocal cord scar, granuloma; 7. History of substance abuse; 8. Pregnant and lactating women. 

研究实施时间:

Study execute time:

From2022-06-08To 2024-06-08 

征募观察对象时间:

Recruiting time:

From2022-06-21To 2023-06-21 

干预措施:

Interventions:

组别:

对照组

样本量:

20

Group:

Group controll

Sample size:

干预措施:

麻醉诱导使用肌肉松弛药顺阿曲库铵

干预措施代码:

Intervention:

Anesthesia induced the use of the muscle relaxation drug cisatracurium

Intervention code:

组别:

试验组

样本量:

20

Group:

Group test

Sample size:

干预措施:

麻醉诱导不用肌肉松弛剂,使用2%利多卡因喷喉

干预措施代码:

Intervention:

Anesthesia was induced without muscle relaxants instead of using a 2% lidocaine spraying throat

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong Province 

City:

Guangzhou 

单位(医院):

广东省中医药 

单位级别:

三级甲等综合型医院 

Institution
hospital:

Guangdong Provincial Hospital of Chinese Medicine  

Level of the institution:

Grade III, Grade A comprehensive hospital 

测量指标:

Outcomes:

指标中文名:

术者手术条件评分

指标类型:

主要指标 

Outcome:

Operative condition score

Type:

Primary indicator 

测量时间点:

手术结束后即刻

测量方法:

手术医生依据评分表内容评分

Measure time point of outcome:

Right after the surgery

Measure method:

The surgeon scores according to the content of the score sheet

指标中文名:

麻醉医生插管条件评分

指标类型:

次要指标 

Outcome:

Anesthesiologist intubation condition score

Type:

Secondary indicator 

测量时间点:

气管插管完成后

测量方法:

插管麻醉医生依据评分表内容评分

Measure time point of outcome:

After endotracheal intubation

Measure method:

Intubation anesthesiologist scores according to the content of the grading sheet

指标中文名:

拔管时间

指标类型:

次要指标 

Outcome:

the time from operation end to extubation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

离开麻醉恢复室时间

指标类型:

次要指标 

Outcome:

the time to leave the anesthesia recovery room

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

插管过程中的喉痉挛和气道损伤情况

指标类型:

次要指标 

Outcome:

Laryngeal spasm and airway injury during intubation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

离开麻醉恢复室时的疼痛评分

指标类型:

次要指标 

Outcome:

Pain scores when leaving the anesthesia recovery room

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后当天恶心呕吐情况

指标类型:

次要指标 

Outcome:

Nausea and vomiting on the day 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:

手术麻醉药物用量、心血管药物用量、术中生命体征

指标类型:

次要指标 

Outcome:

Anaesthetic consumption,intraoperative vital signs andcardiovascular drugs

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:

标本中文名:

组织:

Sample Name:

None

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 65 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):

统计学工作人员采用随机数表法产生随机数列

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

A statisticians use the random table method to generate random numbers

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):

论文发表后即公开原始数据,上传至中国临床试验注册中心(https://www.chictr.org.cn/)

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

The original data will be made public once the papers is published ,it will be uploaded to the Chinese Clinical Trial Registry (https://www.chictr.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:

病例记录表

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

Case Record Form

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2022-07-05
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