ChiCTR2500101483 版本V1.0 版本创建时间2025/04/25 11:20:13 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：

 ChiCTR2500101483 

最近更新日期：

Date of Last Refreshed on：

 2025-04-25 11:20:02 

注册时间：

Date of Registration：

 2025-04-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

苯磺酸瑞马唑仑对胸腔镜肺癌术后恢复质量的影响：与丙泊酚比较的随机对照研究

Public title：

Effect of remimazolam besylate on postoperative recovery quality after thoracoscopic lung cancer surgery: a randomized controlled study comparing with propofol

注册题目简写：

English Acronym：

研究课题的正式科学名称：

苯磺酸瑞马唑仑对胸腔镜肺癌术后恢复质量的影响：与丙泊酚比较的随机对照研究

Scientific title：

Effect of remimazolam besylate on postoperative recovery quality after thoracoscopic lung cancer surgery: a randomized controlled study comparing with propofol

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：

王文珠 

研究负责人：

王文珠 

Applicant：

Wenzhu Wang 

Study leader：

Wenzhu Wang 

申请注册联系人电话：

Applicant telephone：

 +86 158 9878 8836

研究负责人电话：

Study leader's
telephone：

+86 158 9878 8836

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：

 wwz7444@126.com

研究负责人电子邮件：

Study leader's E-mail：

 wwz7444@126.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：

山东省济宁市任城区健康路6号济宁市第一人民医院

研究负责人通讯地址：

山东省济宁市任城区健康路6号济宁市第一人民医院

Applicant address：

Jining No1 People's Hospital, No. 6, Health Road, Rencheng District, Jining City, Shandong Province, China

Study leader's address：

Jining No1 People's Hospital, No. 6, Health Road, Rencheng District, Jining City, Shandong 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：

济宁市第一人民医院

Applicant's institution：

Jining No1 People's Hospital

研究负责人所在单位：

济宁市第一人民医院

Affiliation of the Leader：

Jining No1 People's Hospital

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：

 2025-IIT-快061

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：

济宁市第一人民医院临床研究伦理委员会

Name of the ethic committee：

Clinical Research Ethics Committee of Jining No1 People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-03-15 00:00:00

伦理委员会联系人：

张海亮

Contact Name of the ethic committee：

Hailiang Zhang

伦理委员会联系地址：

济宁市高新区孟子大道269号

Contact Address of the ethic committee：

No.269, Mengzi Avenue, High-Tech Zone, Jining, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 537 605 1221

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：

济宁市第一人民医院

Primary sponsor：

Jining No1 People's Hospital

研究实施负责（组长）单位地址：

山东省济宁市任城区健康路6号

Primary sponsor's address：

No. 6, Health Road, Rencheng District, Jining City, Shandong Province, 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)：

山东省

市(区县)：

济宁市

Country：

China

Province：

Shandong Province

City：

Jining

单位(医院)：

济宁市第一人民医院

具体地址：

山东省济宁市任城区健康路6号

Institution
hospital：

Jining No. 1 People's Hospital

Address：

No.6, Health Road, Rencheng District, Jining City, Shandong Province

经费或物资来源：

企事业单位委托项目（宜昌人福药业有限责任公司）

Source(s) of funding：

Enterprise and public institution commissioned project (Yichang Renfu Pharmaceutical Co., Ltd.)

研究疾病：

肺癌  

Target disease：

lung cancer

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：

 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：

本研究旨在探讨苯磺酸瑞马唑仑与丙泊酚在全身麻醉诱导及恢复期间的差异性，并采用QoR-15量表作为评估工具，以量化两种药物对术后恢复质量的影响。通过这种方法，我们期望能够深入理解苯磺酸瑞马唑仑在实际临床应用中的效果，特别是在术后恢复方面的潜在优势或不足。此外，本研究将为苯磺酸瑞马唑仑在临床麻醉中的使用提供新的见解和科学依据，从而为临床医生在选择麻醉药物时提供更多的参考信息，最终目的是提高患者的手术体验和术后恢复效果。  

Objectives of Study：

This study aims to investigate the differences between remimazolam besylate and propofol during the induction and recovery phases of general anesthesia. The QoR-15 scale was employed as an assessment tool to quantify the impact of these two drugs on the quality of postoperative recovery. Through this approach, we anticipate gaining a comprehensive understanding of the clinical efficacy of remimazolam besylate, particularly its potential advantages or limitations in postoperative recovery. Additionally, this study will provide novel insights and scientific evidence for the use of remimazolam besylate in clinical anesthesia, thereby offering clinicians more reference information when selecting anesthetic agents. The ultimate goal is to enhance patients' surgical experience and postoperative recovery outcomes.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

因原发性肺癌首次行胸腔镜下手术治疗的成人患者；美国麻醉医师协会（American Society of Anesthesiologists，ASA）分级Ⅰ～Ⅲ级，体重指数（body mass index，BMI） 18～30 kg/m2。

Inclusion criteria

Adult patients undergoing thoracoscopic surgery for the first time due to primary lung cancer; American Society of Anesthesiologists (ASA) physical status classification I–III, with a body mass index (BMI) of 18–30 kg/m^2.

排除标准：

术前有明显呼吸或循环功能障碍者；肝肾功能不全（AST、ALT≥1.5倍正常上限，或Cr≥1.5倍正常上限）；高血压未控制或控制不佳者（MAP>120 mmHg）；有酗酒史或阿片类药物或苯二氮?类药物成瘾史，酗酒是指平均每天酒精摄入量超过2单位( 1个单位=360 ml啤酒或45 ml白酒或150 ml 40%酒精的葡萄酒)；由于耳聋、失语或严重精神疾病而无法进行口头交流者；过敏体质或已知对本项目研究方案规定药物及其辅料有过敏史；首次插管不成功者；其他研究者认为不适合参加的情况。

Exclusion criteria：

Patients with significant preoperative respiratory or circulatory dysfunction; patients with hepatic or renal insufficiency (defined as AST or ALT >=1.5 times the upper limit of normal, or Cr >=1.5 times the upper limit of normal); patients with uncontrolled or poorly controlled hypertension (defined as MAP >120 mmHg); patients with a history of alcoholism or addiction to opioids or benzodiazepines, where alcoholism is defined as an average daily alcohol intake exceeding 2 units (1 unit = 360 ml of beer or 45 ml of spirits or 150 ml of 40% wine); patients who are unable to communicate verbally due to deafness, aphasia, or severe psychiatric disorders; patients with allergic constitution or known allergies to the drugs or excipients specified in the study protocol; patients whose initial intubation attempt is unsuccessful; and other situations deemed by the investigators as unsuitable for participation in the study.

研究实施时间：

Study execute time：

从 From 2025-05-17 00:00:00至 To 2027-06-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-01 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

瑞马唑仑组

样本量：

 114

Group：

Rimazolam group

Sample size：

干预措施：

瑞马唑仑组，麻醉诱导时静脉注射苯磺酸瑞马唑仑0.2～0.3 mg/kg，术中持续静脉泵注苯磺酸瑞马唑仑0.4～1 mg/kg/h，术中维持BIS在40～60。

干预措施代码：

Intervention：

In the remazolam group, 0.2-0.3 mg/kg of remazolam besylate was injected intravenously at the time of anesthesia induction, and 0.4-1 mg/kg/h of remazolam besylate was pumped intravenously continuously during the operation, and the Bispectral Index (BIS) was maintained at 40-60 during the operation.

Intervention code：

组别：

丙泊酚组

样本量：

 114

Group：

Propofol group

Sample size：

干预措施：

丙泊酚组，麻醉诱导时静脉注射丙泊酚1～2 mg/kg，术中持续泵注丙泊酚4-10 mg·kg-1·h-1，术中维持BIS在40～60。

干预措施代码：

Intervention：

In the propofol group, 1-2 mg/kg of propofol was injected intravenously at the time of induction of anesthesia, and 4-10 mg/kg/h of propofol was continuously pumped during the operation, and the BIS was maintained at 40-60 during the operation.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东省 

市(区县)：

 济宁市 

Country：

China

Province：

Shandong Province

City：

Jining City

单位(医院)：

 济宁市第一人民医院 

单位级别：

 三甲 

Institution
hospital：

Jining No. 1 People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术后恢复质量

指标类型：

主要指标

Outcome：

Quality of Recovery Scales

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血流动力学变化

指标类型：

次要指标

Outcome：

Hemodynamic changes

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良心血管事件的发生率及血管活性药物累积剂量

指标类型：

次要指标

Outcome：

Incidence of adverse cardiovascular events and cumulative dosage of vasoactive drugs

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后苏醒时间、拔管时间、麻醉恢复室驻留时间

指标类型：

次要指标

Outcome：

Postoperative awakening time, extubation time, post-anesthesia care unit length of stay

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术中知晓及术后谵妄

指标类型：

次要指标

Outcome：

Intraoperative awareness and postoperative delirium

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：

无

组织：

Sample Name：

NA

Tissue：

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 岁 years
最大 Max age 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）：

根据计算机生成的随机数字表，将患者以1:1的比例进行随机化分组。

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

Patients were randomized in a 1:1 ratio according to a computer-generated random number table.

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：

由于瑞马唑仑和丙泊酚的外观很容易被区分，因此对麻醉医生和术中数据收集人员不设盲。同时，麻醉医生可以在紧急情况下有针对性的进行处理。患者、负责招募的医生、在麻醉恢复室和病房进行随访的研究人员、外科医生均不知道患者的分组。

Blinding：

Given that the appearance of remimazolam and propofol can be easily distinguished, blinding was not implemented for the anesthesiologists and the personnel responsible for data collection during the surgery. This arrangement also allows anesthesiologists to provide targeted interventions in emergency situations. However, the patients, the physicians in charge of recruitment, the researchers conducting follow-ups in the post-anesthesia care unit (PACU) and the wards, as well as the surgeons, were all unaware of the group assignments.

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

是Yes

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）：

学术论文发表后在中国临床试验注册中心直接上传公开原始数据

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

Following the publication of the academic paper, the raw data will be directly uploaded and made publicly available on the Chinese Clinical Trial Registry.

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：

1.数据收集 为了提高数据收集质量，我们对数据收集人员进行培训，包括临床试验的目的、重要性、以及数据收集的标准操作程序。数据收集者必须熟悉研究方案，理解研究的设计、目标、纳入和排除标准，以及数据收集的具体要求。除了理论培训外，还应提供实践操作的机会，让数据收集者在监督下进行模拟数据收集，以加深理解和技能掌握。设计临床病例报告表（CRF）供数据收集人员使用。数据录入时双人独立录入数据，对比一致性，如有差异应核对原始数据后重新录入正确数据 。 2.数据管理 在招募前，将建立密码保护的电子记录，以存储患者详细信息。他们的数据将通过指定的识别号码进行编码和识别。我们将指定一名经过培训的独立于研究的调查员来收集研究数据并完成病例报告。知情同意书和研究数据等纸质文件将保存在医院的封闭房间中。受保护的数据集将定期备份(每3个月1次)，并由独立的数据管理员进行同步审计。只有这个管理员才能够在学习期间获得密钥的识别码。在研究结束时，主要研究者将根据指南对数据进行记录和保护。当招募和随访完成后，进行数据的收集、录入和审核，完成所有数据的查询并锁定数据集。为了帮助研究人员理解和重复研究结果，所有数据将在研究完成后存档10年。患者身份的详细信息将不会在任何出版物中报道。

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

1. Data Collection To enhance the quality of data collection, we conducted training for data collectors, covering the purpose and significance of clinical trials, as well as the standard operating procedures for data collection. Data collectors must be familiar with the study protocol, understand the design, objectives, inclusion and exclusion criteria of the study, and the specific requirements for data collection. In addition to theoretical training, opportunities for practical operation should be provided, allowing data collectors to conduct simulated data collection under supervision to deepen their understanding and skill acquisition. Clinical Case Report Forms (CRFs) were designed for use by data collectors. During data entry, two individuals independently entered the data and compared the consistency. In case of discrepancies, the original data were verified and the correct data were re-entered. 2. Data Management Prior to recruitment, password-protected electronic records will be established to store detailed patient information. Their data will be coded and identified using designated identification numbers. A trained investigator, independent of the study, will be designated to collect study data and complete case reports. Paper documents such as informed consent forms and study data will be stored in a locked room at the hospital. The protected dataset will be regularly backed up (once every 3 months) and subject to concurrent audit by an independent data manager. Only this manager will have access to the key identification codes during the study period. At the end of the study, the principal investigator will document and safeguard the data in accordance with guidelines. After recruitment and follow-up are completed, data collection, entry, and review will be conducted, with all data queries resolved and the dataset locked. To facilitate researchers' understanding and replication of study results, all data will be archived for 10 years following study completion. Detailed patient identification information will not be reported in any publications.

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：

  2025-04-25 11:20:02