ChiCTR2500104538 版本V1.0 版本创建时间2025/06/18 16:29:27 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：

 ChiCTR2500104538 

最近更新日期：

Date of Last Refreshed on：

 2025-06-18 16:29:20 

注册时间：

Date of Registration：

 2025-06-18 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

亚麻醉剂量艾司氯胺酮对高原地区老年胃肠肿瘤患者麻醉与神经认知功能的影响

Public title：

The influence of sub-anesthetic dose of esketamine on anesthesia and neurocognitive function in elderly patients with gastrointestinal tumors in plateau areas

注册题目简写：

English Acronym：

研究课题的正式科学名称：

亚麻醉剂量艾司氯胺酮对高原地区老年胃肠肿瘤患者麻醉与神经认知功能的影响

Scientific title：

The influence of sub-anesthetic dose of esketamine on anesthesia and neurocognitive function in elderly patients with gastrointestinal tumors in plateau areas

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：

唐璟 

研究负责人：

唐璟 

Applicant：

Tang jing  

Study leader：

Tang jing 

申请注册联系人电话：

Applicant telephone：

 +86 177 9711 9197

研究负责人电话：

Study leader's
telephone：

+86 177 9711 9197

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：

 tjshelly@163.com

研究负责人电子邮件：

Study leader's E-mail：

 tjshelly@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：

青海省西宁市城西区同仁路29号

研究负责人通讯地址：

青海省西宁市城西区同仁路29号

Applicant address：

No. 29, Tongren Road, Chengxi District, Xining City, Qinghai Province

Study leader's address：

No. 29, Tongren Road, Chengxi District, Xining City, Qinghai Province

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：

青海大学附属医院

Applicant's institution：

Affiliated Hospital of Qinghai University

研究负责人所在单位：

青海大学附属医院

Affiliation of the Leader：

Affiliated Hospital of Qinghai University

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：

 P-SL-2022111

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：

青海大学附属医院科研伦理委员会

Name of the ethic committee：

The Research Ethics Committee of the Affiliated Hospital of Qinghai University

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-12-17 00:00:00

伦理委员会联系人：

李志琴

Contact Name of the ethic committee：

Li Zhiqin

伦理委员会联系地址：

青海省西宁市城西区同仁路29号

Contact Address of the ethic committee：

No. 29, Tongren Road, Chengxi District, Xining City, Qinghai Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 971 616 2033

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：

青海大学附属医院

Primary sponsor：

Affiliated Hospital of Qinghai University

研究实施负责（组长）单位地址：

青海省西宁市城西区同仁路29号

Primary sponsor's address：

No. 29, Tongren Road, Chengxi District, Xining City, Qinghai 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)：

青海省

市(区县)：

西宁市

Country：

China

Province：

Qinghai

City：

Xining

单位(医院)：

青海大学附属医院

具体地址：

青海省西宁市城西区同仁路29号

Institution
hospital：

Affiliated Hospital of Qinghai University

Address：

No. 29, Tongren Road, Chengxi District, Xining City, Qinghai Province

经费或物资来源：

青海大学附属医院

Source(s) of funding：

Affiliated Hospital of Qinghai University

研究疾病：

麻醉与神经认知功能  

Target disease：

Anesthesia and neurocognitive function

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：

胃肠肿瘤作为西北高原地区的常见病种，就医群体以老年居多。血管内皮与大脑功能在老年性退化与高原低氧的双重影响下受到不同程度损伤，因而围术期更易出现血流动力学紊乱和神经认知功能障碍。研究表明亚麻醉剂量艾司氯胺酮具备血流动力学稳定、镇痛效果理想且不影响甚至改善神经认知功能等优势，但因其目前多用于抑郁症治疗，相比之下在麻醉领域的研究极为薄弱，且缺乏在高原老年患者方面的研究。本课题拟纳入70例久居高原的老年胃肠肿瘤患者，通过血流动力学、麻醉药物用量、麻醉苏醒与自主呼吸恢复时间、术后疼痛评分以及认知功能等多项指标表明持续泵注亚麻醉剂量艾司氯胺酮（0.2mg/kg/h）对麻醉与神经认知功能的影响，同时结合血清物质浓度水平对相关机制进行探讨。本课题可进一步推广艾司氯胺酮的“亚麻醉剂量”这一概念，总结用药经验以填补空白，同时为高原地区老年患者提供高质量且安全的麻醉管理方案。  

Objectives of Study：

Gastrointestinal tumor is a common disease in the northwest plateau area, and the elderly are the majority of the patients. Vascular endothelial and brain function are damaged to varying degrees under the dual effects of age-related degeneration and high altitude hypoxia, so hemodynamic disorders and neurocognitive dysfunction are more likely to occur during the perioperative period. Studies have shown that subanesthetic doses of esketamine have the advantages of hemodynamic stability, ideal analgesic effect, and do not affect or even improve neurocognitive function. However, due to its current use in the treatment of depression, the research in the field of anesthesia is extremely weak, and there is a lack of research in elderly patients at high altitude. Seventy elderly patients with gastrointestinal tumors who had been living at high altitude for a long time were enrolled in this study. The effects of continuous pumping of sub-anesthetic dose of esketamine (0.2mg/kg/h) on anesthesia and neurocognitive function were evaluated by hemodynamics, anesthetic drug dosage, anesthesia recovery and spontaneous breathing recovery time, postoperative pain score, and cognitive function. At the same time, the related mechanism was explored in combination with serum substance concentration levels. This study can further promote the concept of "sub-anesthetic dose" of esketamine, summarize the medication experience to fill the gap, and provide high-quality and safe anesthesia management programs for elderly patients in plateau areas.

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.美国麻醉医师协会(American Society of anesthesiologists,ASA)分级Ⅰ～Ⅲ级；2.年龄＞＝60岁；3.体重指数(Body Mass Index,BMI)：18～30kg/m^2；4.手术类型为腹腔镜辅助下胃肠肿瘤（胃癌、结/直肠癌）根治术；5.手术时间限定于3～5小时；6.世居地海拔＞＝2500m；7.对汉语理解及书写无障碍。

Inclusion criteria

1.American Society of anesthesiologists (ASA) grade Ⅰ~Ⅲ; 2.age >=60 years old; 3. Body Mass Index (BMI) : 18-30m^2; 4.The type of surgery was laparoscopic-assisted radical resection of gastrointestinal tumors (gastric cancer, colorectal cancer); 5.The operation time is limited to 3 to 5 hours; 6.native altitude>=2500m; 7.barrier-free Chinese understanding and writing.

排除标准：

1.因慢性疼痛病或癌痛长期服用阿片类药物；2.嗜酒史；3.高血压、冠心病、糖尿病、甲状腺功能亢进、闭塞性血管炎、严重肝肾疾病或贫血病史；4.对课题相关麻醉药物过敏；5.长期服用影响神经精神系统功能药物（如催眠药、抗焦虑药、抗抑郁药等）；6.术前有神经、精神系统疾病史（如脑血栓、脑梗死、高颅压、颅内占位性病变或老年痴呆等）或脑外伤史；7.听觉、视觉障碍；8.既往一个月行其他手术；9.术前MMSE评分文盲＜17分、小学＜20分、初中或以上＜24分；10.对量表问题无法理解或难以沟通患者。

Exclusion criteria：

1.long-term use of opioids for chronic pain or cancer pain; 2.History of alcohol abuse; 3. history of hypertension, coronary heart disease, diabetes mellitus, hyperthyroidism, occlusive vasculitis, severe hepatorenal disease or anemia; 4.allergy to subject-related anesthetic drugs; 5.long-term use of drugs affecting the function of the neuropsychiatric system (such as hypnotics, anxiolytics, antidepressants, etc.); 6.preoperative history of neurological or psychiatric diseases (such as cerebral thrombosis, cerebral infarction, intracranial hypertension, intracranial space occupying lesions, or senile dementia, etc.) or traumatic brain injury; 7.auditory and visual impairment; 8.other surgery in the past month; 9.Preoperative MMSE score of illiterate < 17 points, primary school < 20 points, junior high school or above < 24 points; 10.Inability to understand or communicate with patients on the scale.

研究实施时间：

Study execute time：

从 From 2023-01-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-06-25 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 35

Group：

Experimental Group

Sample size：

干预措施：

麻醉诱导开始前10min以0.2mg/kg/h泵注艾司氯胺酮直至手术结束前10min

干预措施代码：

Intervention：

Esketamine was pumped at 0.2mg/kg/h from 10min before induction until 10min before the end of surgery

Intervention code：

组别：

对照组

样本量：

 35

Group：

Control group

Sample size：

干预措施：

麻醉诱导开始前10min以0.2mg/kg/h泵注生理盐水直至手术结束前10min

干预措施代码：

Intervention：

Normal saline was pumped at 0.2mg/kg/h from 10min before induction until 10min before the end of surgery

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 青海 

市(区县)：

 西宁 

Country：

China

Province：

Qinghai

City：

Xining

单位(医院)：

 青海大学附属医院 

单位级别：

 三甲 

Institution
hospital：

Affiliated Hospital of Qinghai University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

平均动脉压

指标类型：

主要指标

Outcome：

Mean arterial pressure

Type：

Primary indicator

测量时间点：

入室后安静状态下、麻醉诱导即刻、麻醉诱导后1min、切皮后1min、气腹后1min、拔管后1min和拔管后30min

测量方法：

入室后连接心电图和血氧饱和度探头，在局麻下行桡动脉穿刺置管术，成功后连接监护仪测定有创动脉压

Measure time point of outcome：

In a quiet state after entering the room, immediately after anesthesia induction, 1min after anesthesia induction, 1min after skin incision, 1min after pneumoperitoneum, 1min after extubation, and 30min after extubation

Measure method：

The ECG and blood oxygen saturation probe were connected after entering the operating room,radial artery puncture and catheterization was performed under local anesthesia, then connect the monitor to measure invasive arterial pressure

指标中文名：

心率

指标类型：

主要指标

Outcome：

Heart rate

Type：

Primary indicator

测量时间点：

入室后安静状态下、麻醉诱导即刻、麻醉诱导后1min、切皮后1min、气腹后1min、拔管后1min和拔管后30min

测量方法：

入室后连接心电图和血氧饱和度探头，在局麻下行桡动脉穿刺置管术，成功后连接监护仪测定有创动脉压

Measure time point of outcome：

In a quiet state after entering the room, immediately after anesthesia induction, 1min after anesthesia induction, 1min after skin incision, 1min after pneumoperitoneum, 1min after extubation, and 30min after extubation

Measure method：

The ECG and blood oxygen saturation probe were connected after entering the operating room,radial artery puncture and catheterization was performed under local anesthesia, then connect the monitor to measure invasive arterial pressure

指标中文名：

血氧饱和度

指标类型：

主要指标

Outcome：

oxygen saturation of blood

Type：

Primary indicator

测量时间点：

入室后安静状态下、麻醉诱导即刻、麻醉诱导后1min、切皮后1min、气腹后1min、拔管后1min和拔管后30min

测量方法：

入室后连接心电图和血氧饱和度探头，在局麻下行桡动脉穿刺置管术，成功后连接监护仪测定有创动脉压

Measure time point of outcome：

In a quiet state after entering the room, immediately after anesthesia induction, 1min after anesthesia induction, 1min after skin incision, 1min after pneumoperitoneum, 1min after extubation, and 30min after extubation

Measure method：

The ECG and blood oxygen saturation probe were connected after entering the operating room,radial artery puncture and catheterization was performed under local anesthesia, then connect the monitor to measure invasive arterial pressure

指标中文名：

丙泊酚用量

指标类型：

主要指标

Outcome：

Dosage of Propofol

Type：

Primary indicator

测量时间点：

手术结束时

测量方法：

定量计算

Measure time point of outcome：

At the end of the operation

Measure method：

Quantitative calculation

指标中文名：

瑞芬太尼用量

指标类型：

主要指标

Outcome：

Dosage of remifentanil

Type：

Primary indicator

测量时间点：

手术结束时

测量方法：

定量计算

Measure time point of outcome：

At the end of the operation

Measure method：

Quantitative calculation

指标中文名：

去甲肾上腺素用量

指标类型：

主要指标

Outcome：

Dosage of norepinephrine

Type：

Primary indicator

测量时间点：

手术结束时

测量方法：

定量计算

Measure time point of outcome：

At the end of the operation

Measure method：

Quantitative calculation

指标中文名：

自主呼吸恢复时间

指标类型：

主要指标

Outcome：

Time for resuming spontaneous breathing

Type：

Primary indicator

测量时间点：

术后

测量方法：

临床观察

Measure time point of outcome：

After the surgery

Measure method：

clinical observation

指标中文名：

苏醒时间

指标类型：

主要指标

Outcome：

Time for awakening

Type：

Primary indicator

测量时间点：

术后

测量方法：

临床观察

Measure time point of outcome：

After the surgery

Measure method：

clinical observation

指标中文名：

拔管呛咳发生情况

指标类型：

次要指标

Outcome：

Incidence of choking and coughing upon extubation

Type：

Secondary indicator

测量时间点：

术后

测量方法：

临床观察

Measure time point of outcome：

After the surgery

Measure method：

clinical observation

指标中文名：

术后首次排气时间

指标类型：

次要指标

Outcome：

The first time of gastrointestinal tract ventilation after surgery

Type：

Secondary indicator

测量时间点：

术后

测量方法：

临床观察

Measure time point of outcome：

After the surgery

Measure method：

clinical observation

指标中文名：

视觉模拟评分

指标类型：

主要指标

Outcome：

Visual analogue scale

Type：

Primary indicator

测量时间点：

拔管1min、拔管30min、术后2小时、12小时以及24小时

测量方法：

将一条直线等分为10段，两端分别为0和10分，整条直线由0-10递增分别代表不同程度的疼痛，让病人根据个人疼痛情况在相应数字上画圈。0分为无痛，1-3分为轻度疼痛，4-6分为中度疼痛，7-10分为重度疼痛.

Measure time point of outcome：

1,30min after extubation and 2,12,24 hours after surgery

Measure method：

A straight line is divided into 10 segments, with both ends of 0 and 10 points. The whole line increases from 0 to 10, representing different degrees of pain, and let the patient draw a circle on the corresponding number according to the personal pain situation.0 for painless, 1-3 for mild pain, 4-6 for moderate pain, 7-10 for severe pain.

指标中文名：

谵妄评估

指标类型：

主要指标

Outcome：

Delirium assessment

Type：

Primary indicator

测量时间点：

术后1、3和7天

测量方法：

意识模糊评估法中文修订版（CAM-CR）

Measure time point of outcome：

1,3 and 7 days after surgery

Measure method：

Chinese Revised Version of the Confusion Assessment Method (CAM-CR)

指标中文名：

认知功能评估

指标类型：

主要指标

Outcome：

Cognitive Function Assessment

Type：

Primary indicator

测量时间点：

术后1、3和7天

测量方法：

简易智力状态检查（MMSE）量表评分

Measure time point of outcome：

1,3 and 7 days after surgery

Measure method：

Mini-mental State Examination

指标中文名：

术后24小时内镇痛泵首次自控时间

指标类型：

次要指标

Outcome：

The first self-administration time of the analgesic pump within 24 hours after surgery

Type：

Secondary indicator

测量时间点：

术后24小时

测量方法：

病人自控静脉镇痛泵使用记录

Measure time point of outcome：

24 hours after surgery

Measure method：

Record of using Patient-controlled intravenous analgesic pump

指标中文名：

术后24小时内镇痛泵自控次数

指标类型：

次要指标

Outcome：

The frequency of patient-controlled analgesia with the analgesic pump within 24 hours after surgery

Type：

Secondary indicator

测量时间点：

术后24小时

测量方法：

病人自控静脉镇痛泵使用记录

Measure time point of outcome：

24 hours after surgery

Measure method：

Record of using Patient-controlled intravenous analgesic pump

指标中文名：

镇痛满意度评分

指标类型：

次要指标

Outcome：

The satisfaction score of analgesia

Type：

Secondary indicator

测量时间点：

术后24小时

测量方法：

病人自控静脉镇痛泵使用记录

Measure time point of outcome：

24 hours after surgery

Measure method：

Record of using Patient-controlled intravenous analgesic pump

指标中文名：

术后24小时内地佐辛首次使用时间

指标类型：

次要指标

Outcome：

Time of first use dezocine in 24 hours after surgery

Type：

Secondary indicator

测量时间点：

术后24小时

测量方法：

医嘱记录

Measure time point of outcome：

24 hours after surgery

Measure method：

Records of doctor's advice

指标中文名：

术后24小时内地佐辛用量

指标类型：

次要指标

Outcome：

Dosage of dezocine in 24 hours after surgery

Type：

Secondary indicator

测量时间点：

术后24小时

测量方法：

医嘱记录

Measure time point of outcome：

24 hours after surgery

Measure method：

Records of doctor's advice

指标中文名：

术后24小时内恶心呕吐发生情况

指标类型：

次要指标

Outcome：

Occurrence of nausea and vomiting within 24 hours after surgery

Type：

Secondary indicator

测量时间点：

术后24小时

测量方法：

临床观察

Measure time point of outcome：

24 hours after surgery

Measure method：

clinical observation

指标中文名：

白介素-10

指标类型：

主要指标

Outcome：

Interleukin-10

Type：

Primary indicator

测量时间点：

入室后安静状态下、术后1天、术后3天和术后7天

测量方法：

采集患者静脉血5ml,4℃离心（3000r/min,15min）后等分血清为3份，置于冻存管并保存于-80℃冰箱,用于物质浓度测定(ELISA)

Measure time point of outcome：

Quiet state after entering the operating room, 1,3 and 7 days after surgery

Measure method：

Collect 5 ml of venous blood from the patient, centrifuge at 3000 r/min for 15 minutes at 4℃, then take the serum and store it in a cryotube at -80℃ for the determination of substance concentrations (ELISA).

指标中文名：

C反应蛋白

指标类型：

主要指标

Outcome：

C-reactive protein

Type：

Primary indicator

测量时间点：

入室后安静状态下、术后1天、术后3天和术后7天

测量方法：

采集患者静脉血5ml,4℃离心（3000r/min,15min）后取血清，置于冻存管并保存于-80℃冰箱,用于物质浓度测定(ELISA)

Measure time point of outcome：

Quiet state after entering the operating room, 1,3 and 7 days after surgery

Measure method：

Collect 5 ml of venous blood from the patient, centrifuge at 3000 r/min for 15 minutes at 4℃, then take the serum and store it in a cryotube at -80℃ for the determination of substance concentrations (ELISA).

指标中文名：

S100β蛋白

指标类型：

主要指标

Outcome：

S100 β protein

Type：

Primary indicator

测量时间点：

入室后安静状态下、术后1天、术后3天和术后7天

测量方法：

采集患者静脉血5ml,4℃离心（3000r/min,15min）后等分血清为3份，置于冻存管并保存于-80℃冰箱,用于物质浓度测定(ELISA)

Measure time point of outcome：

Quiet state after entering the operating room, 1,3 and 7 days after surgery

Measure method：

Collect 5 ml of venous blood from the patient, centrifuge at 3000 r/min for 15 minutes at 4℃, then take the serum and store it in a cryotube at -80℃ for the determination of substance concentrations (ELISA).

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血清

组织：

静脉

Sample Name：

serum

Tissue：

vein

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 60 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）：

非课题组成员对课题组中的每位患者按照招募时间赋予电脑产生的随机数字（提前由电脑产生70个随机数字，按照招募顺序分别赋予每位患者）

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

Non-research group members assigned computer-generated random numbers to each patient in the research group according to the recruitment time (70 random numbers were generated by computer in advance and assigned to each patient in accordance with the recruitment order).

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：

双盲（对受试者和研究者均隐藏分组）

Blinding：

Double-blind (group assignments were concealed from both subjects and investigators)

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）：

2025年12月31日后通过邮箱(tjshelley@163.com)联系课题负责人申请

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

After December 31, 2025, please contact the project leader via email (tjshelley@163.com) to apply

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：

CRF

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：

  2025-06-18 16:29:20