ChiCTR2400093800 版本V1.0 版本创建时间2024/12/12 09:27:36 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2400093800 

最近更新日期：

Date of Last Refreshed on：

 2024-12-12 09:27:10 

注册时间：

Date of Registration：

 2024-12-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

比较异丙酚复合奥赛利定或芬太尼对不插管静脉全麻患者低氧血症的影响和机制探索的前瞻、双盲、随机、对照研究

Public title：

Comparing the Effects of Propofol Combined with Oxazolidine or Fentanyl on Hypoxemia in Non-Intubated Intravenous General Anesthesia Patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

比较异丙酚复合奥赛利定或芬太尼对不插管静脉全麻患者低氧血症的影响和机制探索的前瞻、双盲、随机、对照研究

Scientific title：

Comparing the Effects of Propofol Combined with Oxazolidine or Fentanyl on Hypoxemia in Non-Intubated Intravenous General Anesthesia Patients

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：

邢纪斌 

研究负责人：

邢纪斌 

Applicant：

Jibin Xing 

Study leader：

Jibin Xing 

申请注册联系人电话：

Applicant telephone：

 +86 135 1272 8239

研究负责人电话：

Study leader's
telephone：

+86 135 1272 8239

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：

 beenjoy@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 beenjoy@qq.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：

广州市天河区天河路600号中山大学附属第三医院麻醉科

研究负责人通讯地址：

广州市天河区天河路600号中山大学附属第三医院麻醉科

Applicant address：

Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Tianhe District, Guangzhou, China

Study leader's address：

Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Tianhe District, Guangzhou, China

申请注册联系人邮政编码：

Applicant postcode：

 510630

研究负责人邮政编码：

Study leader's postcode：

 510630

申请人所在单位：

中山大学附属第三医院

Applicant's institution：

Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Tianhe District, Guangzhou, China

研究负责人所在单位：

中山大学附属第三医院

Affiliation of the Leader：

Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Tianhe District, Guangzhou, China

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：

 中大附三医伦 II2024-274-02

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：

中山大学附属第三医院医学伦理委员会

Name of the ethic committee：

The Medical Ethics Committee of Sun Yat-sen University Third Affiliated Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-10-24 00:00:00

伦理委员会联系人：

黄凯琪

Contact Name of the ethic committee：

Kaiqi Huang

伦理委员会联系地址：

广州市天河区天河路600号中山大学附属第三医院

Contact Address of the ethic committee：

The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Tianhe District, Guangzhou, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 8525 3302

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：

中山大学附属第三医院

Primary sponsor：

The Third Affiliated Hospital of Sun Yat-sen University,

研究实施负责（组长）单位地址：

广州市天河区天河路600号中山大学附属第三医院麻醉科

Primary sponsor's address：

Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Tianhe District, Guangzhou, 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)：

广东

市(区县)：

广州

Country：

China

Province：

guagndong

City：

guagnzhou

单位(医院)：

中山大学附属第三医院

具体地址：

广州市天河区天河路600号中山大学附属第三医院麻醉科

Institution
hospital：

The Third Affiliated Hospital of Sun Yat-sen University,

Address：

Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Tianhe District, Guangzhou, China

经费或物资来源：

广东省医学会基金项目

Source(s) of funding：

Funded by Guangdong Medical Association

研究疾病：

呼吸抑制（低氧血症）  

Target disease：

Respiratory Depression(Hypoxemia)

研究疾病代码：

1

Target disease code：

1

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：

本研究比较异丙酚复合奥赛利定或芬太尼对不插管静脉全麻患者低氧血症的影响，以提高不插管静脉全麻的安全性  

Objectives of Study：

This study is aimed to compare the effects of propofol combined with olceridine or fentanyl on hypoxemia in patients undergoing non-intubated intravenous general anesthesia,and improve the safety of non-intubated intravenous general anesthesia.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

年龄18岁-80岁，ASA1-3级，拟行不插管静脉全麻（无痛胃镜、无痛肠镜或无痛宫腔镜）的患者

Inclusion criteria

Patients aged 18 to 80 years, ASA physical status I–III, scheduled to undergo non-intubated intravenous general anesthesia (Painless gastroscopy or colonoscopy or hysteroscopy)

排除标准：

孕妇、对研究药物过敏史患者、术前使用镇静或镇痛药物者、围术期出现认知功能障碍的患者，术前合并有诸如严重循环和呼吸等系统疾病的患者、ASA 4级的患者、困难气道患者（如BMI＞30Kg/m2者、OASA患者，张口度＜4cm，Mallampati≥3分），膈肌手术、颌面部外伤或手术史者，严重贫血或外周血管严重病变的患者，置入心脏起搏器的患者以及实施治疗操作时间超30分钟的患者

Exclusion criteria：

Pregnant women, patients with a history of allergy to the study drugs, patients who have used sedatives or analgesics preoperatively, patients who experience cognitive dysfunction during the perioperative period, patients with pre-existing severe systemic diseases such as severe circulatory or respiratory diseases, patients classified as ASA grade 4, patients with difficult airways (such as those with a BMI > 30 kg/m2, OSA patients, mouth opening < 4 cm, or Mallampati score ≥ 3), patients with a history of diaphragm surgery, maxillofacial trauma, or surgery, patients with severe anemia or severe peripheral vascular disease, patients with implanted cardiac pacemakers, and patients undergoing therapeutic procedures lasting more than 30 minutes.

研究实施时间：

Study execute time：

从 From 2025-01-01 00:00:00至 To 2025-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-02-01 00:00:00 至 To 2025-09-29 00:00:00

干预措施：

Interventions：

组别：

奥赛利定复合异丙酚组

样本量：

 73

Group：

Group OP(Oliceridine +Propofol)

Sample size：

干预措施：

使用奥赛利定和异丙酚诱导麻醉

干预措施代码：

Intervention：

Anesthesia was administered with olceridine and propofol

Intervention code：

组别：

对照组为FP组（Fentanyl +Propofol，芬太尼复合异丙酚组）：

样本量：

 73

Group：

Group FP(Fentanyl +Propofol)

Sample size：

干预措施：

使用芬太尼和异丙酚诱导麻醉

干预措施代码：

Intervention：

Anesthesia was administered with olcerilidine and propofol

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：

Gaungdong

City：

Guangzhou

单位(医院)：

 中山大学附属第三医院 

单位级别：

 三甲 

Institution
hospital：

The Third Affiliated Hospital of Sun Yat-sen University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

低氧血症发生率

指标类型：

主要指标

Outcome：

Incidence of hypoxemia

Type：

Primary indicator

测量时间点：

实时

测量方法：

监护仪

Measure time point of outcome：

realtime

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

Not Applicable

Tissue：

Not Applicable

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 岁 years
最大 Max age 80 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）：

使用数据处理软件Matlab（版本号：R2020b）生成随机序列，由研究者E负责保管，并分装于密封不透光的信封中按序取用，并将相应全麻药物交于麻醉医生A，患者按照1:1的比例随机分配到OP组和FP组。

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

A random sequence was generated using data processing software Matlab (version: R2020b) by the researcher E, who was responsible for storing it and sealing it in opaque, air-tight envelopes in sequence. The corresponding general anesthetic drugs were then given to the anesthesiologist A, and the patients were allocated to the OP group and FP group in a 1:1 ratio randomly.

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：

本研究对受试者、医护提供者、结局评估者、数据分析者设盲： 分组设盲：受试者不了解自己所处的组别，医护提供者、结局评估者、数据分析者设盲也不了解受试者的组别，仅研究者E知晓分组情况。具体方法是研究者E使用数据处理软件Matlab（版本号：R2020b）生成随机序列并将序列表分装于密封不透光的信封中按序取用决定受试者的分组 药物外观的盲法处理：研究者E根据分组情况制备好对应的全麻药物交于麻醉医生A，奥赛利定和芬太尼均为无色，肉眼下不能分辨两种制剂，两种药物体积相同均稀释至5毫升； 医护提供者、结局评估者、数据分析者分工明确，均不了解分组情况：麻醉医生A收到相应全麻药物后按照常规流程进行麻醉和处置；麻醉医生B负责操作B超实时评估和记录受试者的膈肌舒缩情况；麻醉医生C负责记录受试者的除膈肌超声外的其他指标；研究者D负责汇总和录入指标数据并进行统计分析。

Blinding：

This study blinded the subjects, healthcare providers, outcome assessors, and data analysts: Group blinding: The subjects were unaware of their group assignment, and the healthcare providers, outcome assessors, and data analysts were blinded to the subjects' group assignment as well. Only researcher E knew the group assignment. Specifically, researcher E used data processing software Matlab (version: R2020b) to generate a random sequence and divided the sequence list into sealed, opaque envelopes to determine the subjects' group assignment. Blinding of the appearance of the medication: Researcher E prepared the corresponding general anesthetic drugs according to the group assignment and handed them over to anesthesiologist A. Oselefin and fentanyl are both colorless, and they cannot be distinguished by the naked eye. The two drugs have the same volume and are diluted to 5 milliliters. The healthcare providers, outcome assessors, and data analysts were clearly defined in their roles and were unaware of the group assignment: Anesthesiologist A received the corresponding general anesthetic drugs and proceeded with the standard procedure for anesthesia and management. Anesthesiologist B was responsible for operating the B-ultrasound in real-time to evaluate and record the subject's diaphragmatic contraction and relaxation. Anesthesiologist C was responsible for recording the subject's other indicators except for the diaphragmatic ultrasound. Researcher D was responsible for compiling and inputting the indicator data and conducting statistical analysis.

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）：

百度网盘

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

Baidu web disk

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：

Baidu web disk

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

Baidu web disk

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：

  2024-12-12 09:27:10