ChiCTR2500101702 版本V1.1 版本创建时间2025/07/30 08:22:50 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：

 ChiCTR2500101702 

最近更新日期：

Date of Last Refreshed on：

 2025-04-28 16:48:20 

注册时间：

Date of Registration：

 2025-04-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

瑞马唑仑对腹腔镜结直肠手术的老年患者术后谵妄的影响

Public title：

Effect of remimazolam on postoperative delirium in elderly patients undergoing laparoscopic colorectal surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

术中使用瑞马唑仑与丙泊酚对腹腔镜结直肠手术的老年患者术后谵妄的影响

Scientific title：

Effect of Intraoperative Use of Remimazola or Propofol on Postoperative Delirium in Elderly Patients With Laparoscopic Colorectal Surger

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：

卢莹莹 

研究负责人：

饶竹青 

Applicant：

Lu Yingying 

Study leader：

Rao Zhuqing 

申请注册联系人电话：

Applicant telephone：

 +86 132 9528 6182

研究负责人电话：

Study leader's
telephone：

+86 133 4783 3675

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：

 13295286182@163.com

研究负责人电子邮件：

Study leader's E-mail：

 rzqqzhm@163.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：

江苏省南京市鼓楼区广州路300号

研究负责人通讯地址：

江苏省南京市鼓楼区广州路300号

Applicant address：

No. 300, Guangzhou Road, Gulou District, Nanjing, Jiangsu Province

Study leader's address：

No. 300, Guangzhou Road, Gulou District, Nanjing, Jiangsu Province

申请注册联系人邮政编码：

Applicant postcode：

 210029

研究负责人邮政编码：

Study leader's postcode：

 210029

申请人所在单位：

南京医科大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Nanjing Medical University, Nanjing

研究负责人所在单位：

南京医科大学第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Nanjing Medical University, Nanjing

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：

 2023-SR-798

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：

南京医科大学第一附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Nanjing Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-02-27 00:00:00

伦理委员会联系人：

刘存明

Contact Name of the ethic committee：

Liu Cunming

伦理委员会联系地址：

南京市广州路300号江苏省人民医院7号楼3楼

Contact Address of the ethic committee：

3rd Floor, Building 7, Jiangsu Provincial People's Hospital, No. 300 Guangzhou Road, Nanjing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 25 6830 6360

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：

南京医科大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Nanjing Medical University, Nanjing

研究实施负责（组长）单位地址：

江苏省南京市鼓楼区广州路300号

Primary sponsor's address：

No. 300, Guangzhou Road, Gulou District, Nanjing, Jiangsu Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏

市(区县)：

Country：

China

Province：

Jiangsu

City：

单位(医院)：

南京医科大学第一附属医院

具体地址：

江苏省南京市鼓楼区广州路300号

Institution
hospital：

anesthesiology department

Address：

No. 300, Guangzhou Road, Gulou District, Nanjing, Jiangsu Province

经费或物资来源：

南京医科大学第一附属医院

Source(s) of funding：

The First Affiliated Hospital of Nanjing Medical University, Nanjing

研究疾病：

结直肠癌  

Target disease：

Colorectal 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：

结直肠癌（ CRC ）是消化系统中最常见的恶性肿瘤，是全球第三大，我国第二大最常见的癌症，严重危害人民群众健康。结直肠癌的发病率随着年龄的增长迅速上升，同时随着社会老龄化和检查方法的进步，老年CRC患者的数量近年来持续增加。腹腔镜肠癌根治术，可减少侵入性创伤、减轻疼痛并加速术后肠道功能的恢复，尤为适用于老年CRC患者。术后谵妄（POD）是一种以记忆障碍和意识障碍为主要特征的急性认知功能障碍。常发生在术后2-5天，总发病率约为23%，老年结肠癌根治性手术患者术后谵妄发生率为13.8% -30%。瑞马唑仑对呼吸系统和循环系统的抑制较小。多项研究显示，与丙泊酚相比，瑞马唑仑可显著降低呼吸抑制、低血压和心动过缓等不良事件发生率。目前关于瑞马唑仑对老年腹腔镜结直肠癌术后患者的影响还没有确切研究。  

Objectives of Study：

Colorectal cancer (CRC) is the most common malignant tumor in the digestive system, the third largest and the second most common cancer in my country, and seriously endangering the health of the people. The incidence of colorectal cancer has increased rapidly with age. At the same time, with the aging of society and the advancement of examination methods, the number of elderly patients with CRC has continued to increase in recent years. Laparoscopic radical resection of colon cancer can reduce invasive trauma, reduce pain and accelerate the recovery of intestinal function after surgery, especially for elderly patients with CRC. Postoperative delirium (POD) is an acute cognitive dysfunction characterized by memory and consciousness disorders. It often occurs 2-5 days after surgery, with a total incidence rate of about 23%, and the incidence of postoperative delirium in elderly patients with radical colon cancer surgery is 13.8%-30%. Remazolam has less inhibition on the respiratory and circulatory systems. Several studies have shown that compared with propofol, remazolam can significantly reduce the incidence of adverse events such as respiratory depression, hypotension and bradycardia. There is currently no definite study on the effect of remazolam on elderly patients with laparoscopic colorectal cancer.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.原发性结直肠癌； 2.拟行腹腔镜下结直肠癌根治术； 3.年龄60-90岁。

Inclusion criteria

1. Primary colorectal cancer; 2. Planned laparoscopic radical colorectal cancer resection; 3. Age 60-90 years old.

排除标准：

1.近期服用精神类药物及有精神疾患的病人； 2.曾经发生过术后谵妄的病人； 3.对丙泊酚或苯二氮卓类药品过敏的病人； 4.术前存在严重呼吸、心脏、肝肾功能不全的患者； 5.既往阿尔兹海默症或痴呆的诊断，以及短时幸福测试提示认知功能受损的老年受试者。

Exclusion criteria：

1. Patients who have recently taken psychotropic drugs and have mental disorders; 2. Patients who have had postoperative delirium; 3. Patients who are allergic to propofol or benzodiazepines; 4. Patients with severe respiratory, cardiac, liver and kidney insufficiency before surgery; 5. Previous diagnosis of Alzheimer's disease or dementia, and impaired cognitive function indicated by short-term well-being tests. 1. Patients who have recently taken psychotropic drugs and have mental disorders; 2. Patients who have had postoperative delirium; 3. Patients who are allergic to propofol or benzodiazepines; 4. Patients with severe respiratory, cardiac, liver and kidney insufficiency before surgery; 5. Previous diagnosis of Alzheimer's disease or dementia, and impaired cognitive function indicated by short-term well-being tests.

研究实施时间：

Study execute time：

从 From 2023-06-01 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-04-30 00:00:00 至 To 2026-04-30 00:00:00

干预措施：

Interventions：

组别：

丙泊酚组

样本量：

 200

Group：

Propofol group

Sample size：

干预措施：

麻醉诱导：丙泊酚组以丙泊酚2.0 mg/kg诱导全身麻醉以静注舒芬太尼0.5 ug/kg和顺式阿曲库铵0.15 mg/kg。 麻醉维持：丙泊酚组以丙泊酚4-8mg/kg/h和瑞芬太尼0.05-0.20μg/kg/min维持麻醉。调整丙泊酚剂量以维持BIS范围在40~60之间。 插管后行机械通气，设置呼吸频率为12次/min，潮气量为8ml/kg，呼气末二氧化碳分压维持在35-45mmHg，氧流量2L/min。 术毕转入麻醉恢复室，予以阿托品+新斯的明拮抗残余肌松效应，如果患者有拮抗禁忌（哮喘、冠心病），则不使用新斯的明拮抗肌松。或诱导维持使用罗库溴铵。待患者自主呼吸、呛咳反射及肌张力恢复后拔除气管导管，观察30min后由麻醉护士送回外科病房。

干预措施代码：

 P

Intervention：

Anesthesia Maintenance: In the Propofol group, anesthesia was maintained with Propofol 4–8 mg/kg/h and Remifentanil 0.05–0.20 μg/kg/min. The dose of Propofol was adjusted to maintain the BIS range between 40 and 60. Mechanical ventilation was initiated after intubation, with a respiratory rate set at 12 breaths/min, tidal volume at 8 ml/kg, end-tidal carbon dioxide partial pressure maintained at 35–45 mmHg, and oxygen flow at 2 L/min. After surgery, patients were transferred to the post-anesthesia care unit (PACU). Atropine and Neostigmine were administered to reverse residual neuromuscular blockade unless contraindicated (e.g., asthma, coronary heart disease), in which case Neostigmine was not used. Alternatively, Rocuronium could be used for induction and maintenance. After confirming recovery of spontaneous breathing, cough reflex, and muscle tone, the endotracheal tube was removed. Patients were observed for 30 minutes before being transferred back to the surgical ward by an anesthesia nurse.

Intervention code：

组别：

瑞马唑仑组

样本量：

 200

Group：

Remimazolam group

Sample size：

干预措施：

麻醉诱导：瑞马唑仑组以瑞马唑仑0.2 mg/kg诱导全身麻醉，以静注舒芬太尼0.5 ug/kg和顺式阿曲库铵0.15 mg/kg； 麻醉维持：瑞马唑仑组给予瑞马唑仑0.5~1.0mg/kg/h和瑞芬太尼0.05-0.20μg/kg/min，1-3 μg/kg/min顺式阿曲库铵维持麻醉。调整瑞马唑仑剂量以维持BIS范围在40~60之间。 插管后行机械通气，设置呼吸频率为12次/min，潮气量为8ml/kg，呼气末二氧化碳分压维持在35-45mmHg，氧流量2L/min； 术毕转入麻醉恢复室，予以阿托品+新斯的明拮抗残余肌松效应，如果患者有拮抗禁忌（哮喘、冠心病），则不使用新斯的明拮抗肌松。或诱导维持使用罗库溴铵。拮抗时瑞马唑仑组加用氟马西尼特异性拮抗，待患者自主呼吸、呛咳反射及肌张力恢复后拔除气管导管，观察30min后由麻醉护士送回外科病房。

干预措施代码：

 R

Intervention：

Anesthesia Induction: In the Remimazolam group, general anesthesia was induced with Remimazolam 0.2 mg/kg, intravenous Sufentanil 0.5 μg/kg, and Cisatracurium 0.15 mg/kg. Anesthesia Maintenance: The Remimazolam group received Remimazolam 0.5–1.0 mg/kg/h and Remifentanil 0.05–0.20 μg/kg/min, along with Cisatracurium 1–3 μg/kg/min to maintain anesthesia. The dose of Remimazolam was adjusted to maintain the BIS range between 40 and 60. Mechanical ventilation was initiated after intubation, with a respiratory rate set at 12 breaths/min, tidal volume at 8 ml/kg, end-tidal carbon dioxide partial pressure maintained at 35–45 mmHg, and oxygen flow at 2 L/min. After surgery, patients were transferred to the post-anesthesia care unit (PACU). Atropine and Neostigmine were administered to reverse residual neuromuscular blockade unless contraindicated (e.g., asthma, coronary heart disease), in which case Neostigmine was not used. Alternatively, Rocuronium could be used for induction and maintenance. For reversal in the Remimazolam group, Flumazenil was added as a specific antagonist. After confirming recovery of spontaneous breathing, cough reflex, and muscle tone, the endotracheal tube was removed. Patients were observed for 30 minutes before being transferred back to the surgical ward by an anesthesia nurse.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

  

Country：

China

Province：

Jiangsu

City：

单位(医院)：

 南京医科大学第一附属医院 

单位级别：

 三甲 

Institution
hospital：

The First Affiliated Hospital of Nanjing Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术后谵妄发生率

指标类型：

主要指标

Outcome：

Incidence of postoperative delirium

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

恢复时间（手术结束至气管拔除的时间）

指标类型：

次要指标

Outcome：

Recovery time (time from the end of surgery to tracheal 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：

住院时间

指标类型：

次要指标

Outcome：

Length of stay

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：

None

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 60 岁 years
最大 Max age 90 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）：

随机数字表

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

Table of random numbers

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：

对负责分组的统计人员和进行随访和统计分析的研究人员以及受试者设盲

Blinding：

The statisticians responsible for the group, the researchers who performed follow-up and statistical analysis, and the subjects were blinded

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）：

无

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

None

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：

无

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

None

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-04-28 16:48:11