中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2400090887
最近更新日期： Date of Last Refreshed on：	2024-10-15 09:13:49
注册时间： Date of Registration：	2024-10-15 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	比较舒芬太尼与奥赛利定对改善术后镇痛及认知障碍影响
Public title：	To compare the effects of sufentanil and oxalidine on improving postoperative analgesia and postoperative cognitive dysfunction
注册题目简写：
English Acronym：
研究课题的正式科学名称：	比较舒芬太尼与奥赛利定对改善术后镇痛及认知障碍影响
Scientific title：	To compare the effects of sufentanil and oxalidine on improving postoperative analgesia and postoperative cognitive dysfunction
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：	张珺雁	研究负责人：	林培敏
Applicant：	Junyan Zhang	Study leader：	Peimin Lin
申请注册联系人电话： Applicant telephone：	+86 135 6816 5581	研究负责人电话： Study leader's telephone：	+86 139 8245 2939
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：	2665144213@qq.com	研究负责人电子邮件： Study leader's E-mail：	284238497@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：	四川省泸州市龙马潭区春晖路182号	研究负责人通讯地址：	四川省泸州市龙马潭区春晖路182号
Applicant address：	182 Chunhui Road, Longmadan District, Luzhou City, Sichuan Province	Study leader's address：	182 Chunhui Road, Longmadan District, Luzhou City, Sichuan 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：	西南医科大学附属中医医院
Applicant's institution：	Hospital of Traditional Chinese Medicine Affiliated to Southwest Medical University
研究负责人所在单位：	西南医科大学附属中医医院
Affiliation of the Leader：	Hospital of Traditional Chinese Medicine Affiliated to Southwest Medical 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：	KY2024042	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：	西南医科大学附属中医医院医学伦理审查委员会
Name of the ethic committee：	Medical Ethics Review Committee of Traditional Chinese Medicine Hospital Affiliated to Southwest Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2024-09-27 00:00:00
伦理委员会联系人：	曾海燕
Contact Name of the ethic committee：	Haiyan Zeng
伦理委员会联系地址：	四川省泸州市龙马潭区春晖路182号
Contact Address of the ethic committee：	182 Chunhui Road, Longmadan District, Luzhou City, Sichuan Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 830 251 6312	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：

西南医科大学附属中医医院

Primary sponsor：

Hospital of Traditional Chinese Medicine Affiliated to Southwest Medical University

研究实施负责（组长）单位地址：

四川省泸州市龙马潭区春晖路182号

Primary sponsor's address：

182 Chunhui Road, Longmadan District, Luzhou City, 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)：	泸州市
Country：	China	Province：	Sichua	City：	Luzhou
单位(医院)：	西南医科大学附属中医医院	具体地址：	四川省泸州市龙马潭区春晖路182号
Institution hospital：	Hospital of Traditional Chinese Medicine Affiliated to Southwest Medical University	Address：	182 Chunhui Road, Longmadan District, Luzhou City, Sichuan Province

经费或物资来源：

吴阶平医学基金会

Source(s) of funding：

Wu Jie-ping Medical Foundation

研究疾病：

术后认知功能障碍

Target disease：

postoperative cognitive dysfunction

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：

本研究目的是比较G蛋白µ-阿片受体激动剂奥赛利定与舒芬太尼的术后疼痛疗效及对术后认知障碍的影响，以明确是否奥赛利定在疼痛管理和认知保护方面更好。

Objectives of Study：

The aim of this study is to compare the effects of the G protein µ-opioid receptor agonist oxalidine and sufentanil on postoperative pain and postoperative cognitive impairment in order to determine whether oxalidine is better in terms of pain management and cognitive protection.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

（1）已知对试验用药物组成成分过敏者；（2）无法合作者，如精神障碍或预期有神经心理学评估困难，与发音或方言相关的沟通困难。（3）有酒精、药物滥用史者；（4）正在参加或试验前12周内参加过其他临床试验者；（5）其他根据研究者的判断，不宜参加该临床试验者，如：急性或慢性感染性疾病、二次手术、ASA评分大于Ⅲ级、文盲、1个月内中风或短暂性脑缺血发作。

Exclusion criteria：

(1) known to be allergic to the components of the investigational drug; (2) inability to cooperate, such as mental disorders or anticipated difficulties with neuropsychological assessment, communication difficulties related to pronunciation or dialect. (3) those with a history of alcohol or drug abuse; (4) participants who were enrolled in or had enrolled in another clinical trial within 12 weeks before the trial; (5) Other patients who, in the judgment of the investigator, would not be eligible to participate in the trial, such as acute or chronic infectious diseases, secondary surgery, ASA score greater than grade III, illiteration, stroke or transient ischemic attack within 1 month.

研究实施时间：

Study execute time：

从 From 2024-10-20 00:00:00至 To 2025-11-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-10-20 00:00:00 至 To 2025-11-01 00:00:00

干预措施：

Interventions：

组别：	舒芬太尼组	样本量：	96
Group：	Sufentanil group	Sample size：	96
干预措施：	麻醉诱导：舒芬太尼组：静脉推注丙泊酚1～1.5 mg/kg，舒芬太尼0.3ug/kg，待患者意识消失时，给与顺式阿曲库铵0.2 mg/kg，待达到满意的肌松状态后，进行气管插管辅以机械通气。麻醉维持：舒芬太尼组：麻醉维持采用持续静脉输注丙泊酚，当临床表现显示镇痛效应显著减弱时，使用舒芬太尼0.15ug/kg，术中采用持续静脉输注顺式阿曲库铵0.1～0.2 mg·kg -1·h -1维持患者肌松状态。调整药物的泵注速率维持患者的BIS在40-60之间，心率在60-100之间，平均动脉压在70-100mmHg之间。液体管理：术中使用晶体液维持，速度5-10ml/kg/h，术中输血由经验丰富的麻醉医生视患者具体情况而定。研究药物给药后做好术中数据以及不良反应的记录。术后阶段：缝皮时结束所有药物输注，采用静脉自控镇痛泵进行术后镇痛，舒芬太尼组药物选择1-2ug/kg舒芬太尼+昂丹司琼8mg+盐水→100ml，负荷剂量为1-3μg，单次剂量为2-4ug，锁定时间为5-10min。	干预措施代码：
Intervention：	Induction of anesthesia: Sufentanil group: intravenous injection of propofol 1-1.5 mg/kg, sufentanil 0.3ug/kg, when the patient lost consciousness, cisatracurium 0.2 mg/kg, until a satisfactory state of muscle relaxation, tracheal intubation and mechanical ventilation. Maintenance of anesthesia: Sufentanil group: continuous intravenous infusion of propofol was used to maintain anesthesia, sufentanil 0.15ug/kg was used when clinical manifestations showed that the analgesic effect was significantly weakened, and cisatracurium 0.1-0.2 mg· kg-1 · h-1 was used to maintain the patient's muscle relaxation state during operation. The pump rate of the drug was adjusted to maintain the patient's BIS between 40 and 60, heart rate between 60 and 100, and mean arterial pressure between 70 and 100 MMHG. Fluid management: Crystalloid was used for maintenance during the operation at a rate of 5-10ml/kg/h, and intraoperative blood transfusion was determined by an experienced anesthesiologist depending on the specific condition of the patient. The intraoperative data and adverse reactions were recorded after the administration of study drugs. Postoperative stage: The patients in sufentanil group received sufentanil 1-2ug/kg + ondansetron 8mg+ saline 100ml. The loading dose was 1-3μg, the single dose was 2-4ug, and the lockout time was 5-10min. The patients in sufentanil group received sufentanil 1-2ug/kg + ondansetron 8mg+ saline 100ml.	Intervention code：

组别：	奥赛利定组	样本量：	96
Group：	The Oxalidine group	Sample size：	96
干预措施：	麻醉诱导：奥赛利定组：静脉推注丙泊酚1～1.5 mg/kg，奥赛利定60 ug/kg，待患者意识消失时，给与顺式阿曲库铵0.2 mg/kg，待达到满意的肌松状态后，进行气管插管辅以机械通气。麻醉维持：奥赛利定组：麻醉维持采用持续静脉输注丙泊酚，奥赛利定每 1~3 小时按需给予 30 ug/kg，术中采用持续静脉输注顺式阿曲库铵0.1～0.2 mg·kg -1·h -1维持患者肌松状态。调整药物的泵注速率维持患者的BIS在40-60之间，心率在60-100之间，平均动脉压在70-100mmHg之间。液体管理：术中使用晶体液维持，速度5-10ml/kg/h，术中输血由经验丰富的麻醉医生视患者具体情况而定。研究药物给药后做好术中数据以及不良反应的记录。术后阶段：缝皮时结束所有药物输注，采用静脉自控镇痛泵进行术后镇痛，奥赛利定组患者药物选择0.2-0.4mg/kg奥赛利定+昂丹司琼8mg+盐水→100ml。首次给予负荷剂量静脉推注1.5mg，单次剂量为0.5mg，锁定时间为6min，按需补充 1 mg。	干预措施代码：
Intervention：	Induction of anesthesia: The patients in the oxalidine group received intravenous injection of propofol 1-1.5 mg/kg and oxalidine 60 ug/kg, and cisatracurium 0.2 mg/kg was given when the patients lost consciousness. After achieving a satisfactory state of muscle relaxation, tracheal intubation and mechanical ventilation were performed. Maintenance of anesthesia: In the oxalidine group, propofol was maintained by continuous intravenous infusion, and oxalidine 30 ug/kg was given every 1 to 3 hours as needed. During the operation, cisatracurium 0.1-0.2 mg· kg-1 · h-1 was continuously infused to maintain muscle relaxation. The pump rate of the drug was adjusted to maintain the patient's BIS between 40 and 60, heart rate between 60 and 100, and mean arterial pressure between 70 and 100 MMHG. Fluid management: Crystalloid was used for maintenance during the operation at a rate of 5-10ml/kg/h, and intraoperative blood transfusion was determined by an experienced anesthesiologist depending on the specific condition of the patient. The intraoperative data and adverse reactions were recorded after the administration of study drugs. Postoperative stage: All drug infusion was finished at the time of skin suture, and postoperative analgesia was performed by intravenous patient-controlled analgesia pump. Patients in the oxalidine group were treated with 0.2-0.4mg/kg oxalidine + ondansetron 8mg+ saline →100ml. A loading dose of 1.5mg was given as a single bolus of 0.5mg, with a lockout time of 6 minutes, and 1 mg was added as needed.	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)：
Country：	China	Province：	Sichuan Province	City：
单位(医院)：	西南医科大学附属中医医院	单位级别：	三甲
Institution hospital：	Hospital of Traditional Chinese Medicine Affiliated to Southwest Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	术后认知障碍的发生率	指标类型：	主要指标
Outcome：	Incidence of postoperative cognitive impairment	Type：	Primary indicator
测量时间点：	术后第一天、第三天、第七天、第十五天、第三十天	测量方法：	MoCA‐BC量表测量
Measure time point of outcome：	The first day, the third day, the seventh day, the fifteenth day and the thirtieth day after operation	Measure method：	Moca-bc scale measurement

指标中文名：	患者镇痛药物使用情况	指标类型：	次要指标
Outcome：	The use of analgesic drugs in patients	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	患者疼痛程度	指标类型：	次要指标
Outcome：	Patient's pain level	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	患者在手术过程中平均动脉压	指标类型：	次要指标
Outcome：	The mean arterial pressure of the patients during the procedure	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24h不良反应情况	指标类型：	次要指标
Outcome：	Adverse reactions within 24 hours after operation were recorded	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	患者住院时长	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：

指标中文名：	术后24 h连续脉搏血氧饱和度	指标类型：	次要指标
Outcome：	Continuous pulse oxygen saturation was measured 24 hours after surgery	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	术后首次排便时间	指标类型：	次要指标
Outcome：	The first postoperative defecation time	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	首次下地活动时间	指标类型：	次要指标
Outcome：	The first time of ground movement	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	65	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）：

将192位患者从1到192编号，获取随机数字:从随机数字表中任意一个数开始,沿同一方向顺序获取每个实验单位一个随机数字，随机数除以2求余数。若整除则余数取2，若余数为1，则为舒芬太尼组；若余数为2，则为奥赛利定组。选取每个患者所接受镇痛药物方案由产生的随机分配序列产生。产生随机分配序列和确定受试患者合格性的研究人员不是同一个人，且产生和保存随机分配序列的人员是不参与试验的人员。

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

192 patients were numbered from 1 to 192 to obtain a random number: starting from any number in the random number table, a random number for each experimental unit was obtained sequentially in the same direction, and the remainder was obtained by dividing the random number by 2. If the remainder was equal to 1, it was sufentanil group. If the remainder is 2, it is an Orselian group. The analgesic regimen selected for each patient was generated from the generated randomization sequence. The randomization sequence was generated by a different investigator than the one who determined the eligibility of the trial patients, and the randomization sequence was generated and maintained by persons not involved in the trial.

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：	本研究设立评价研究者和给药研究者，仅对评价研究者设盲。
Blinding：	The evaluation investigators and the administration investigators were appointed, and only the evaluation investigators were blinded.
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	2026.3.1
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	2026.3.1
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：	一为病例记录表
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case Record Form, CRF
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：	2024-10-15 09:13:09