ChiCTR2500097283 版本V1.0 版本创建时间2025/02/17 11:15:42 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：

ChiCTR2500097283 

最近更新日期：

Date of Last Refreshed on：

2025-02-17 11:15:28 

注册时间：

Date of Registration：

2025-02-17 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

超声下瞳孔测量法精准调控右美托咪定术中用量的临床研究

Public title：

Clinical Study on Accurate Control of Dexmedetomidine Dosage by Pupillary Measurement under Ultrasound

注册题目简写：

English Acronym：

研究课题的正式科学名称：

超声下瞳孔测量法精准调控右美托咪定术中用量的临床研究

Scientific title：

Clinical Study on Accurate Control of Dexmedetomidine Dosage by Pupillary Measurement under Ultrasound

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：

杨梦娇 

研究负责人：

黄丹 

Applicant：

Mengjiao Yang 

Study leader：

Dan Huang 

申请注册联系人电话：

Applicant telephone：

+86 177 8141 8189

研究负责人电话：

Study leader's telephone：

+86 159 0817 1790

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：

2281351392@qq.com

研究负责人电子邮件：

Study leader's E-mail：

huangdan1790@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：

四川省成都市新都区宝光大道中段278号

研究负责人通讯地址：

四川省成都市新都区宝光大道中段278号

Applicant address：

No.278, Middle Section of Baoguang Avenue, Xindu District, Chengdu, Sichuan Province

Study leader's address：

No.278, Middle Section of Baoguang Avenue, Xindu District, Chengdu, Sichuan Province

申请注册联系人邮政编码：

Applicant postcode：

610500

研究负责人邮政编码：

Study leader's postcode：

610500

申请人所在单位：

成都医学院第一附属医院

Applicant's institution：

The First Affiliated Hospital of Chengdu Medical College

研究负责人所在单位：

成都医学院第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Chengdu Medical College

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2024CYFYIRB-BA-Dec17

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：

成都医学院第一附属医院医学伦理委员会

Name of the ethic committee：

The First Affiliated Hospital of Chengdu Medical College IRB

伦理委员会批准日期：

Date of approved by ethic committee：

2025-01-15 00:00:00

伦理委员会联系人：

朱青芝

Contact Name of the ethic committee：

Qingzhi Zhu

伦理委员会联系地址：

四川省成都市新都区宝光大道中段278号

Contact Address of the ethic committee：

No.278, Middle Section of Baoguang Avenue, Xindu District, Chengdu, Sichuan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 28 8301 6069

伦理委员会联系人邮箱：

Contact email of the ethic committee：

cyfylunli@163.com

研究实施负责（组长）单位：

成都医学院第一附属医院

Primary sponsor：

The First Affiliated Hospital of Chengdu Medical College

研究实施负责（组长）单位地址：

四川省成都市新都区宝光大道中段278号

Primary sponsor's address：

No.278, Middle Section of Baoguang Avenue, Xindu District, Chengdu, Sichuan 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)：

四川省

市(区县)：

成都市

Country：

China

Province：

Sichuan Province

City：

Chengdu

单位(医院)：

成都医学院第一附属医院

具体地址：

四川省成都市新都区宝光大道中段278号

Institution
hospital：

The First Affiliated Hospital of Chengdu Medical College

Address：

No.278, Middle Section of Baoguang Avenue, Xindu District, Chengdu, Sichuan Province

经费或物资来源：

成都医学院第一附属医院麻醉科

Source(s) of funding：

Department of Anesthesiology, First Affiliated Hospital of Chengdu Medical College

Target disease：

None

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究拟通过一项双盲、前瞻性、随机对照研究，与传统麻醉深度评价指标，如心率、血压、脑电双频谱指数相比较，获取术中右美托咪定泵注速度改变次数、变异系数、调整响应时间、药物总消耗量、苏醒时间、不良事件及发生率，验证超声瞳孔观测法对于行择期腹腔镜手术的患者能够在术中对右美托咪定用量进行精准调控。  

Objectives of Study：

Through a double-blind, prospective, randomized controlled study, compared with traditional evaluation indexes of anesthesia depth, such as heart rate, blood pressure and bispectrum index of EEG, this study intends to obtain the number of changes in pumping speed of dexmedetomidine during operation, coefficient of variation, adjustment response time, total drug consumption, awakening time, adverse events and incidence rate, and verify that ultrasonic pupillary observation can accurately control the dosage of dexmedetomidine during operation for patients undergoing elective laparoscopic surgery.

药物成份或治疗方案详述：

无 

Description for medicine or protocol of treatment in detail：

None 

纳入标准：

2025年2月至2025年5月，成都医学院附属第一医院，拟在静吸复合麻醉下行腹腔镜手术的患者。 （1）基本情况：18岁及以上、非妊娠、非哺乳患者；ASA分级I~II级；体质指数18.5~23.9kg/m^2； （2）检验检查：心电图诊断为“窦性心律，正常心电图”；胸部CT和（或）X线无明显异常；血生化（肝肾功能、电解质、血常规、凝血功能、传染病抗原抗体等）结果均无明显异常； （3）既往史：无临床前期和临床确诊的心肺慢性疾病，无神经及精神系统疾病，无眼外伤史、眼部疾病和高度近视（近视度数大于600度），术前无镇痛镇静药、抗凝抗板药、血管活性药使用史，无过敏及抗过敏治疗史，无恶性肿瘤及放化疗史，无全身感染史； （4）麻醉专科检查：代谢当量>=3METs；术前2周内无吸烟、酗酒；颈部和颞下颌关节活动度良好，Mallampati分级1-II级，张口度>=3.5cm或患者的三横指，甲颏距离>=6.5cm，牙齿完整无松动、缺失。

Inclusion criteria

From February, 2025 to May, 2025, the First Affiliated Hospital of Chengdu Medical College planned to perform laparoscopic surgery under combined intravenous anesthesia. (1) Basic information: non-pregnant, non-breastfeeding patients aged 18 and above; ASA classification I~II; Body mass index is 18.5 ~ 23.9 kg/m^2; (2) Inspection: ECG diagnosis is 'sinus rhythm, normal ECG'; There is no obvious abnormality in chest CT and/or X-ray; The results of blood biochemistry (liver and kidney function, electrolyte, blood routine, coagulation function, infectious disease antigen antibody, etc.) were not obviously abnormal; (3) Past history: no pre-clinical and clinically diagnosed chronic heart and lung diseases, no neurological and mental system diseases, no history of eye injuries, eye diseases and high myopia (myopia degree is greater than 600 degrees), no history of using analgesic and sedative drugs, anticoagulants and vasoactive drugs before operation, no history of allergy and antiallergic treatment, no history of malignant tumors, radiotherapy and chemotherapy, and no history of systemic infection; (4) Specialized examination of anesthesia: metabolic equivalent>=3 mets; No smoking or drinking within 2 weeks before operation; The mobility of the neck and temporomandibular joint is good, Mallampati grade is 1-II, the mouth opening degree is >=3.5cm or the patient's three horizontal fingers, the distance of the chin is >=6.5cm, and the teeth are intact without looseness or loss.

排除标准：

（1）基本情况：18岁以下患者，妊娠、哺乳的患者；ASA分级III及以上；BMI<18.5和>23.9kg/m^2； （2）检验检查：心电图异常；胸部CT和（或）X线显著异常；血生化指标任何一项出现显著异常； （3）既往史：包括但不限于心肺肝肾的急慢性疾病，神经、精神系统疾病，眼外伤史、眼部疾病和高度近视，术前应用特殊药物，麻醉药物相关不良事件发生史，过敏及抗过敏治疗史，急慢性全身感染； （4）麻醉专科检查：代谢当量<3METs；术前2周内未戒烟、戒酒；存在1条及以上困难气道指证，如颈部和颞下颌关节活动度不足或关节脱位，Mallampati分级III级及以上，张口度<3.5cm或患者的三横指，甲颏距离<6.5cm；牙齿松动、缺失。

Exclusion criteria：

(1) Basic information: patients under 18 years old, pregnant and breastfeeding patients; ASA grade III and above; BMI<18.5 and > 23.9 kg/m^2; (2) Inspection: abnormal electrocardiogram; Chest CT and/or X-ray are significantly abnormal; There is significant abnormality in any of the blood biochemical indexes; (3) Past history: including but not limited to acute and chronic diseases of heart, lung, liver and kidney, diseases of nervous and mental system, history of eye injury, eye diseases and high myopia, preoperative use of special drugs, history of adverse events related to narcotic drugs, history of allergy and antiallergic treatment, and acute and chronic systemic infection; (4) Specialized examination of anesthesia: metabolic equivalent < 3 mets; Did not quit smoking and drinking within 2 weeks before operation; There are one or more difficult airway finger syndromes, such as insufficient mobility or dislocation of the neck and temporomandibular joint, Mallampati grade III or above, mouth opening less than 3.5cm or the patient's three horizontal fingers, and nail mental distance less than 6.5cm;; Loose and missing teeth.

研究实施时间：

Study execute time：

从 From 2025-01-16 00:00:00至 To 2025-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-02-20 00:00:00 至 To 2025-05-31 00:00:00  

干预措施：

Interventions：

组别：

心率+血压组

样本量：

71

Group：

Heart rate+blood pressure group

Sample size：

干预措施：

该组患者被予以咪达唑仑5分钟后测量一次心率和血压作为基线值，此后每5分钟记录一次；若一次记录中，心率增快或收缩压升高，升高幅度达到并超过基线值的15%，则将右美托咪定泵注速度增加0.05μg/kg/h；反之，心率减慢或收缩压降低，达到甚至低于基线值的85%，则将右美托咪定泵注速度减少0.05μg/kg/h。

干预措施代码：

 None

Intervention：

Patients in this group will be given midazolam for 5 minutes, and their heart rate and blood pressure will be measured as baseline values, and then recorded every 5 minutes. If the heart rate increases or the systolic blood pressure increases in one record, and the increase reaches or exceeds 15% of the baseline value, the pumping speed of dexmedetomidine will be increased by 0.05 μ g/kg/h; Conversely, if the heart rate slows down or the systolic blood pressure decreases to 85% of the baseline value, the pumping speed of dexmedetomidine will be reduced by 0.05 μ g/kg/h.

Intervention code：

组别：

脑电双频谱指数组

样本量：

71

Group：

Bispectral index of EEG group

Sample size：

干预措施：

经过麻醉诱导后，该组患者的气管导管得到妥善固定，此刻读取数值作为麻醉维持状态的麻醉深度基线值，此后每5分钟记录一次；若一次记录中，BIS≥60，则将右美托咪定泵注速度增加0.05μg/kg/h；反之，BIS<=39，则将右美托咪定泵注速度减少0.05μg/kg/h。

干预措施代码：

 None

Intervention：

After anesthesia induction, the tracheal catheter of this group of patients was properly fixed. At this moment, the value was read as the baseline value of anesthesia depth in anesthesia maintenance state, and it was recorded every 5 minutes thereafter. If BIS≥60 in one record, increase the pumping speed of dexmedetomidine by 0.05μ g/kg/h; On the other hand, BIS<=39 will reduce the pumping speed of dexmedetomidine by 0.05 μ g/kg/h.

Intervention code：

组别：

超声下瞳孔测量组

样本量：

71

Group：

Pupil measurement under ultrasound group

Sample size：

干预措施：

该组患者被予以受试者咪达唑仑5分钟后，研究人员将用超声测量一次瞳孔直径并作为基线值，紧接着予以强直刺激，根据瞳孔直径变化计算出瞳孔疼痛指数；此后，从进入麻醉维持期开始，每5分钟测量一次瞳孔直直径、每20分钟予以强直电流刺激并计算出PPI值；将PPI=4-6视为适宜的镇痛水平，若术中出现PPI=1-3，则将泵注速度下调0.05μg/kg/h，若术中出现PPI为7-9，则泵注速度增加0.05μg/kg/h。

干预措施代码：

 None

Intervention：

Five minutes after the patients in this group were given midazolam, the researchers will use ultrasound to measure the pupil diameter as the baseline value, and then give tonic stimulation to calculate the pupil pain index according to the change of pupil diameter. After that, from the beginning of anesthesia maintenance period, the straight pupil diameter was measured every 5 minutes, and the tonic current was stimulated every 20 minutes to calculate the PPI value. PPI=4-6 is considered as an appropriate analgesic level. If PPI=1-3 occurs during the operation, the pumping speed will be lowered by 0.05μg/kg/h, and if PPI is 7-9 during the operation, the pumping speed will be increased by 0.05 μ g/kg/h..

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川省 

市(区县)：

 成都市 

Country：

China 

Province：

Sichuan Province 

City：

Chengdu 

单位(医院)：

成都医学院第一附属医院 

单位级别：

三甲 

Institution
hospital：

The First Affiliated Hospital of Chengdu Medical College

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

右美托咪定泵注速度改变次数

指标类型：

主要指标

Outcome：

Number of changes in pumping speed of dexmedetomidine

Type：

Primary indicator

测量时间点：

手术结束时

测量方法：

Measure time point of outcome：

At the end of the operation

Measure method：

指标中文名：

右美托咪定泵注速度变异系数

指标类型：

主要指标

Outcome：

Variation coefficient of pumping speed of dexmedetomidine

Type：

Primary indicator

测量时间点：

手术结束时

测量方法：

Measure time point of outcome：

At the end of the operation

Measure method：

指标中文名：

右美托咪定总消耗量

指标类型：

主要指标

Outcome：

Total consumption of dexmedetomidine

Type：

Primary indicator

测量时间点：

手术结束时

测量方法：

Measure time point of outcome：

At the end of the operation

Measure method：

指标中文名：

苏醒时间

指标类型：

主要指标

Outcome：

Awakening event

Type：

Primary indicator

测量时间点：

从手术结束到拔除气管导管

测量方法：

Measure time point of outcome：

From the end of the operation to the removal of the tracheal catheter

Measure method：

指标中文名：

不良事件发生情况

指标类型：

主要指标

Outcome：

Occurrence of adverse events

Type：

Primary indicator

测量时间点：

苏醒后5分钟、进麻醉恢复室、出麻醉恢复室

测量方法：

Measure time point of outcome：

5 minutes after awakening, enter the anesthesia recovery room and leave the anesthesia recovery room

Measure method：

指标中文名：

性别

指标类型：

次要指标

Outcome：

Gender

Type：

Secondary indicator

测量时间点：

术前访视

测量方法：

Measure time point of outcome：

Preoperative visit

Measure method：

指标中文名：

年龄

指标类型：

次要指标

Outcome：

Age

Type：

Secondary indicator

测量时间点：

术前访视

测量方法：

Measure time point of outcome：

Preoperative visit

Measure method：

指标中文名：

身高

指标类型：

次要指标

Outcome：

Height

Type：

Secondary indicator

测量时间点：

术前访视

测量方法：

Measure time point of outcome：

Preoperative visit

Measure method：

指标中文名：

体重

指标类型：

次要指标

Outcome：

Weight

Type：

Secondary indicator

测量时间点：

术前访视

测量方法：

Measure time point of outcome：

Preoperative visit

Measure method：

指标中文名：

ASA分级

指标类型：

次要指标

Outcome：

ASA grading

Type：

Secondary indicator

测量时间点：

术前访视

测量方法：

Measure time point of outcome：

Preoperative visit

Measure method：

指标中文名：

手术总时长

指标类型：

次要指标

Outcome：

Total duration of operation

Type：

Secondary indicator

测量时间点：

手术结束后

测量方法：

Measure time point of outcome：

After the operation

Measure method：

指标中文名：

麻醉总时长

指标类型：

次要指标

Outcome：

Total duration of anesthesia

Type：

Secondary indicator

测量时间点：

拔除气管导管后

测量方法：

Measure time point of outcome：

After the tracheal catheter is removed

Measure method：

指标中文名：

心率

指标类型：

次要指标

Outcome：

Heart rate

Type：

Secondary indicator

测量时间点：

予以咪达唑仑5分钟后及以后每隔5分钟

测量方法：

Measure time point of outcome：

Five minutes after midazolam administration and every five minutes thereafter

Measure method：

指标中文名：

有创收缩压

指标类型：

次要指标

Outcome：

Invasive systolic blood pressure

Type：

Secondary indicator

测量时间点：

予以咪达唑仑5分钟后及以后每隔5分钟

测量方法：

Measure time point of outcome：

Five minutes after midazolam administration and every five minutes thereafter

Measure method：

指标中文名：

平均动脉压

指标类型：

次要指标

Outcome：

Mean arterial pressure

Type：

Secondary indicator

测量时间点：

予以咪达唑仑5分钟后及以后每隔5分钟

测量方法：

Measure time point of outcome：

Five minutes after midazolam administration and every five minutes thereafter

Measure method：

指标中文名：

脑电双频谱指数

指标类型：

次要指标

Outcome：

Bispectral index of EEG

Type：

Secondary indicator

测量时间点：

气管插管固定后及以后每隔5分钟

测量方法：

Measure time point of outcome：

After tracheal intubation is fixed and every 5 minutes thereafter

Measure method：

指标中文名：

瞳孔直径

指标类型：

次要指标

Outcome：

Pupil diameter

Type：

Secondary indicator

测量时间点：

予以咪达唑仑5分钟后及以后每隔5分钟

测量方法：

Measure time point of outcome：

Five minutes after midazolam administration and every five minutes thereafter

Measure method：

指标中文名：

瞳孔疼痛指数

指标类型：

次要指标

Outcome：

Pupillary pain index

Type：

Secondary indicator

测量时间点：

予以咪达唑仑5分钟后及以后每隔20分钟

测量方法：

Measure time point of outcome：

After giving midazolam for 5 minutes and every 20 minutes thereafter

Measure method：

指标中文名：

右美托咪定泵注速度调整响应时间

指标类型：

次要指标

Outcome：

Response Time of Dexmedetomidine Pumping Speed Adjustment

Type：

Secondary indicator

测量时间点：

从监测到需要调整泵注速度到实际完成泵注速度调整并达到新的稳定状态的时间

测量方法：

Measure time point of outcome：

Time from monitoring the need to adjust the pumping speed to actually completing the pumping speed adjustment and reaching a new stable state.

Measure method：

指标中文名：

阿片类药物总消耗量

指标类型：

次要指标

Outcome：

Total consumption of opioids

Type：

Secondary indicator

测量时间点：

离开麻醉恢复室后

测量方法：

Measure time point of outcome：

After leaving the anesthesia recovery room

Measure method：

指标中文名：

七氟烷总消耗量

指标类型：

次要指标

Outcome：

Total sevoflurane consumption

Type：

Secondary indicator

测量时间点：

手术结束后

测量方法：

Measure time point of outcome：

After the operation

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 18 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）：

研究执行人利用 SPSS 软件完成类似计算机随机数表法的随机分组过程，确保分组的随机性和客观性。

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

The research executor uses SPSS software to complete the random grouping process similar to the computer random number table method to ensure the randomness and objectivity of grouping.

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：

本研究是一项双盲试验，患者和麻醉医生不知道分组情况，仅有数据记录分析员知晓。通过计算机随机数表法和密封不透光信封法使得患者不知道自己所在的分组，每一位受试者配备的麻醉医生可能不尽相同，经过培训后均按照研究设定的麻醉方法实施麻醉，亦不知晓分组情况；数据分析人员的任务包括指导受试者通过密封不透光信封法完成分组、术中根据分组采取干预手段、记录整理分析数据，故从始至终知晓分组情况。

Blinding：

This study is a double-blind trial. Patients and anesthesiologists don't know the grouping situation, only data recording analysts know it. Through computer random number table method and sealed opaque envelope method, patients do not know their own grouping, and each subject may be equipped with different anesthesiologists. After training, they all perform anesthesia according to the anesthesia method set by the study, and they do not know the grouping situation. The tasks of the data analyst include guiding the subjects to complete grouping by sealing the airtight envelope, taking intervention measures according to grouping during the operation, and recording and analyzing the data, so they know the grouping situation from beginning to end.

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

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：

1.数据收集 受试者信息表格设计：在实验开展前精心制作详细的表格，确保涵盖所有主次要观察指标丰富且关键的信息。表格的排头包括性别、年龄、身高、体重、ASA分级。表格第一行标题包括心率、有创收缩压、平均动脉压、脑电双频谱指数、瞳孔直径、右美托咪定泵注速度、阿片类药物泵注速度、七氟烷吸入浓度、不良事件。表格第一列标题包括入室时间、麻醉开始时间、气管插管时间、手术开始时间、间隔5分钟的具体时间、手术结束时间、气管拔管时间、出室时间。表格末尾包括手术时间、麻醉时间、苏醒时间、右美托咪定泵注速度改变次数、右美托咪定泵注速度调整响应时间、右美托咪定和阿片类药物和七氟烷术毕总消耗量。通过这种结构化的表格设计，能够系统、全面地收集每一位受试者在整个实验过程中的相关数据，避免数据遗漏和混乱。 超声下瞳孔测量数据采集：每位受试者进行超声下瞳孔测量时，利用超声自带的硬件进行录屏并储存，在试验结束后，将录屏转存至电脑，借助专业的图像处理软件记录瞳孔直径和瞳孔扩张反射相关数据。这种方法不仅提高了数据采集的准确性，而且图像处理软件能够提供更为精确地测量结果，相比传统的手工测量方式，减少了人为因素对数据准确性的影响，使得瞳孔相关数据的收集更加科学可靠。 2.数据管理 将上述收集到的所有数据，包括表格中的受试者基本信息、各项生理指标数据以及超声测量后处理得到的瞳孔数据一一录入统计分析软件IBM SPSS Statistics 26.0中。在录入过程中，严格遵循数据录入的规范和流程，仔细核对每一个数据，确保数据的准确性和完整性。与此同时，利用 SPSS 软件强大的功能键完成一系列数据的整理分析工作：首先，对录入的数据进行“清洗”，识别并处理缺失值、异常值等问题，然后根据研究的目的和设计，选择合适的统计分析方法。

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

1. Data collection Design of information table of subjects: Make detailed tables carefully before the experiment, to ensure that all rich and key information of primary and secondary observation indicators is covered. The top of the form includes gender, age, height, weight and ASA rating. The headings in the first row of the table include heart rate, invasive systolic blood pressure, average arterial pressure, bispectral index of EEG, pupil diameter, pumping speed of dexmedetomidine, pumping speed of opioid drugs, inhalation concentration of sevoflurane and adverse events. The first column of the table includes the time of entering the room, the start time of anesthesia, the time of tracheal intubation, the start time of operation, the specific time of 5 minutes interval, the end time of operation, the time of tracheal extubation and the time of leaving the room. At the end of the table, the operation time, anesthesia time, awakening time, the number of changes of dexmedetomidine pumping speed, the response time of dexmedetomidine pumping speed adjustment, and the total consumption of dexmedetomidine, opioids and sevoflurane after operation are included. Through this structured table design, the relevant data of each subject in the whole experiment process can be collected systematically and comprehensively to avoid data omission and confusion. Data collection of pupil measurement under ultrasound: When each subject performs pupil measurement under ultrasound, the screen is recorded and stored by the hardware provided by ultrasound. After the experiment, the screen is transferred to a computer, and the relevant data of pupil diameter and pupil dilation and reflection are recorded by professional image processing software. This method not only improves the accuracy of data collection, but also can provide more accurate measurement results by image processing software. Compared with the traditional manual measurement method, it reduces the influence of human factors on data accuracy and makes the collection of pupil-related data more scientific and reliable. 2. Data management All the data collected above, including the basic information of the subjects in the table, the data of various physiological indexes and the pupil data obtained by ultrasonic measurement post-processing, are entered into the statistical analysis software IBM SPSS Statistics 26.0. In the process of data entry, strictly follow the norms and processes of data entry, and carefully check each data to ensure the accuracy and integrity of the data. At the same time, using the powerful function keys of SPSS software to complete a series of data sorting and analysis work: first, "clean" the input data, identify and deal with missing values, abnormal values and other issues, and then choose the appropriate statistical analysis method according to the purpose and design of the study.

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：

  2025-02-17 11:15:29