ChiCTR2200063137 版本V1.1 版本创建时间2023/04/05 13:36:33 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：

 ChiCTR2200063137 

最近更新日期：

Date of Last Refreshed on：

 2022-08-31 15:39:33 

注册时间：

Date of Registration：

 2022-08-31 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

艾司氯胺酮在成人重度烧伤换药中的镇痛作用— 一项前瞻性随机对照研究

Public title：

Analgesic effect of esketamine in dressing change for severe burns in adults: a prospective randomized controlled study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

艾司氯胺酮在成人重度烧伤换药中的镇痛作用— 一项前瞻性随机对照研究

Scientific title：

Analgesic effect of esketamine in dressing change for severe burns in adults: a prospective randomized controlled study

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：

李俊杰 

研究负责人：

刘志恒 

Applicant：

Li Junjie 

Study leader：

Liu Zhiheng 

申请注册联系人电话：

Applicant telephone：

 13602587542

研究负责人电话：

Study leader's
telephone：

15818505570

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：

 916281680@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 zhiheng_liu_tongji@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：

广东省深圳市福田区笋岗西路3002号

研究负责人通讯地址：

广东省深圳市福田区笋岗西路3002号

Applicant address：

No. 3002 Sungang West Road, Futian District, Shenzhen City, Guangdong Province, China

Study leader's address：

No. 3002 Sungang West Road, Futian District, Shenzhen City, Guangdong Province, China

申请注册联系人邮政编码：

Applicant postcode：

 518000

研究负责人邮政编码：

Study leader's postcode：

 518000

申请人所在单位：

深圳市第二人民医院

Applicant's institution：

Shenzhen Second People's Hospital

研究负责人所在单位：

深圳市第二人民医院

Affiliation of the Leader：

Shenzhen Second 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：

 20220412006-FS01

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：

深圳市第二人民医院临床科研伦理委员会

Name of the ethic committee：

Clinical Research Ethics Committee of Shenzhen Second People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-05-26 00:00:00

伦理委员会联系人：

吴明

Contact Name of the ethic committee：

Wu Ming

伦理委员会联系地址：

广东省深圳市福田区笋岗西路3002号

Contact Address of the ethic committee：

No. 3002 Sungang West Road, Futian District, Shenzhen City, Guangdong Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

深圳市第二人民医院

Primary sponsor：

Shenzhen Second People's Hospital

研究实施负责（组长）单位地址：

广东省深圳市福田区笋岗西路3002号

Primary sponsor's address：

No. 3002 Sungang West Road, Futian District, Shenzhen City, Guangdong 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)：

广东

市(区县)：

深圳

Country：

China

Province：

Guangdong

City：

Shenzhen

单位(医院)：

深圳市第二人民医院

具体地址：

福田区笋岗西路3002号

Institution
hospital：

Shenzhen Second People's Hospital

Address：

3002 Sun'gang Road West, Futian District

经费或物资来源：

院内科研经费

Source(s) of funding：

Research Fund of the Hospital

研究疾病：

烧伤  

Target disease：

Burn

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：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

主要目的：拟通过使用艾司氯胺酮在成人重度烧伤换药中进行镇痛镇静，探讨艾司氯胺酮在减少阿片类药物使用的优势 次要目的：评估艾司氯胺酮在重度烧伤换药中的镇痛作用：降低患者的疼痛评分；减少监护下镇静相关并发症；降低患者早期抑郁的发生率；提高患者及烧伤科医生满意度  

Objectives of Study：

Objective: To study the analgesic sedation of esselketamine in dressing change of severe burns in adults, and to explore the advantages of esselketamine in reducing the use of opioids Secondary objective: To evaluate the analgesic effect of esketamine in dressing change of severe burns: to reduce the pain score of patients; Reduce sedation-related complications under supervision; Reduce the incidence of early depression in patients; Improve the satisfaction of patients and burn doctors

药物成份或治疗方案详述：

1.干预措施 1.1根据是否使用艾司氯胺酮分为两组，分别为使用艾司氯胺酮的试验组和不使用艾司氯胺酮的对照组 1.2配药护士根据分组信息准备“研究用药”：对照组使用10ml透明注射器抽取10ml“生理盐水”。试验组使用10ml透明注射器抽取“艾司氯胺酮”（2ml：50mg），并用生理盐水稀释至10ml（5mg/ml）。配备完毕后，在注射器贴上注有受试者编号、姓名、住院号的标签，然后将药物交给麻醉操作人员 1.3在换药前10min，两组患者先予泵注1μg/kg右美托咪定负荷量，静注布托啡诺1mg。在换药前1min，研究人员将“研究用药”按0.1ml/kg体重对患者进行静脉注射。即对照组接受0.1ml/kg生理盐水，试验组接受0.5mg/kg艾司氯胺酮 2.研究步骤 2.1筛选期：烧伤患者完成植皮手术后回到烧伤重症监护室，由访视者对其进行筛查，根据纳入/排除标准招募患者入组；向患者及其授权委托人充分说明本研究的目的、方法及可能带来的益处和危害，并说明在换药当天及换药后3天进行量表评估。详细解答患者及委托人的疑问，给予其充分的考虑时间，在完全自愿的前提下请患者委托人签署知情同意书。访视者不参与该患者换药期间的管理。完成术前资料采集。烧伤科医生根据患者实际情况，提前一天提交镇静清创换药申请单 2.2入选治疗期 2.2.1清创换药前，对患者进行生命体征监护，包括心率、血压、脉搏氧饱和度，无法监测无创动脉压则进行动脉穿刺行连续动脉压测量。使用疼痛评分（SF-MPQ）评估患者疼痛程度，并记录生命体征的基线值。患者常规鼻导管吸氧3L/min，已行气管切开患者则通过造瘘口连接呼吸机辅助通气（SIMV模式，呼吸频率12次/分，潮气量300~400ml，吸氧浓度60%） 2.2.2在换药前10min，两组患者均开始泵注1μg/kg右美托咪定负荷量，静注布托啡诺1mg。换药前1min，研究人员将“研究用药”按0.1ml/kg体重对患者进行静脉注射 2.2.3换药开始前，记录患者镇静RSS评分，随后调整右美托咪定泵速至0.5μg/kg/h，开始进行换药操作。在换药期间，为提供充分镇痛，两组患者均设置补救措施。如果患者收缩压升高20%，或有自主动作、吞咽及痛苦面容时，评估镇静深度，当RSS≤4时认为镇痛不充分，此时给予静脉注射补救药物芬太尼0.5μg/kg。观察5min，RSS仍≤4分，则继续追加芬太尼0.5μg/kg 2.2.4换药期间间隔3分钟测量并记录血压BP、心率HR和脉搏氧饱和度SpO2。记录低氧血症（SpO2＜90%）、心动过缓（心率＜50次/分）、低血压（收缩压＜80mmHg）发生次数及具体时间。记录开始用药到镇静评分RSS＞4的时间 2.2.5换药结束之后，记录换药操作的使用时间，右美托咪定、布托啡诺和艾司氯胺酮的使用剂量，补救药物芬太尼的使用次数及使用剂量。使用RSS每间隔1分钟评估一次患者的镇静状态，当RSS评分为1分时认为患者苏醒，记录复苏时间（操作完成到患者RSS 1分） 2.3随访：患者苏醒后评估疼痛评分（SF-MPQ），患者的满意度评分及烧伤科医师操作满意度评分。患者换药后3天进行住院焦虑抑郁量表评分（HAD），评估并记录患者短期抑郁状态；由烧伤科医师对创面的渗液情况进行评估，研究人员对渗液情况进行记录。15天后记录并发症发生率。记录患者的住院天数 

Description for medicine or protocol of treatment in detail：

1. Interventions 1.1 Two groups were divided according to whether or not esketamine was used: the experimental group using esketamine and the control group not using esketamine 1.2 Dispensing nurses prepared "study medication" according to group information: the control group used a 10ml transparent syringe to extract 10ml "normal saline". The experimental group was used to extract "esticketamine" (2ml: 50mg) with a 10ml transparent syringe, and diluted to 10ml (5mg/ml) with normal saline. Once equipped, the syringe is labeled with subject number, name, and hospital number, and the drug is handed to the anesthesia operator 1.3 10min before dressing change, patients in both groups were injected 1μg/kg dexmedetomidine by pump and 1mg butorphanol by iv. The "study drug" was administered intravenously at 0.1ml/kg body weight 1min before dressing change. The control group received 0.1 mL /kg normal saline, and the experimental group received 0.5mg/kg esticketamine 2. Research procedures 2.1 Screening period: Burn patients returned to the burn intensive care unit after skin grafting surgery, were screened by visitors, and recruited according to inclusion/exclusion criteria; The purpose, method and possible benefits and harms of this study were fully explained to patients and their authorized clients, and scale evaluation was performed on the day of dressing change and 3 days after dressing change. Answer the questions of the patient and client in detail, give them sufficient time to consider, and ask the patient and client to sign the informed consent on the premise of completely voluntary. The visitor does not participate in the management of the patient during dressing change. Preoperative data collection was completed. According to the actual situation of the patient, the doctor of the department of burns should submit the application form for sedation debridement and dressing change one day in advance 2.2 Included treatment period 2.2.1 Before debridement and dressing change, patients were monitored for vital signs, including heart rate, blood pressure and pulse oxygen saturation. If non-invasive arterial pressure could not be monitored, continuous arterial pressure was measured by arterial puncture. Pain was assessed using the SF-MPQ and baseline vital signs were recorded. Patients received conventional nasal catheter oxygen inhalation of 3L/min, patients who had undergone tracheotomy were connected to ventilators through the stoma for auxiliary ventilation (SIMV mode, respiratory rate of 12 times /min, tidal volume of 300-400mL, oxygen concentration of 60%) 2.2.2 10min before dressing change, patients in both groups began pumping 1μg/kg dexmedetomidine load and intravenous butorphanol 1mg. 1min before dressing change, the "study drug" was intravenously injected at 0.1ml/kg body weight 2.2.3 Before dressing change, THE patient's SEDation RSS score was recorded, and then the pump rate of dexmedetomidine was adjusted to 0.5μg/kg/h to start dressing change. During dressing change, remedial measures were set up in both groups to provide adequate analgesia. Depth of sedation was assessed if systolic blood pressure increased by 20%, or patients had voluntary movement, swallowing, and painful appearance. Analgesia was considered inadequate when RSS≤4, and intravenous fentanyl 0.5μg/kg was administered. After observation for 5 minutes, when RSS was still ≤4 points, fentanyl 0.5μg/kg was added 2.2.4 Blood pressure BP, heart rate HR and pulse oxygen saturation SpO2 were measured and recorded at an interval of 3 minutes during dressing change. The frequency and specific time of hypoxemia (SpO2 < 90%), bradycardia (heart rate < 50 beats/min) and hypotension (systolic blood pressure < 80mmHg) were recorded. The time from medication initiation to SEDation score RSS > 4 was recorded 2.2.5 After dressing change, record the duration of dressing change, dosage of dexmedetomidine, butorphanol and esticketamine, frequency and dosage of fentanyl. The patient's sedation status was evaluated by USING RSS every 1 minute. When the RSS score was 1, the patient was considered to be awake and the recovery time was recorded (the operation was completed until the patient's RSS was 1 minute). 2.3 Follow-up: The pain score, patient satisfaction score and operation satisfaction score of physicians in the department of burn were evaluated after the patients woke up. Inpatient anxiety and depression Scale score (HAD) was performed 3 days after dressing change, and short-term depression status of patients was assessed and recorded. Wound exudation was assessed by the burn physician and recorded by the researcher. Complication rates were recorded after 15 days. Length of stay was recorded 

纳入标准：

美国麻醉医师协会ASA 分级II ~ Ⅳ级
重度及以上烧伤患者
年龄18岁-60岁
签署知情同意书的患者

Inclusion criteria

American Society of Anesthesiologists ASA Grades II to iv
Patients with severe or higher burns
Ages 18 to 60
Patients who signed informed consent forms

排除标准：

肝、肾功能不全
对拟使用药物过敏
有抗抑郁药物或抗精神病药物使用史
二度及以上房室传导阻滞
无法配合的患者

Exclusion criteria：

Hepatic and renal insufficiency
Allergy to intended medication
History of antidepressant or antipsychotic drug use
Atrioventricular block of second degree or higher
Patients who can't cooperate

研究实施时间：

Study execute time：

从 From 2022-08-01 00:00:00至 To 2025-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-09-01 00:00:00 至 To 2024-10-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 26

Group：

Experimental group

Sample size：

干预措施：

烧伤换药前使用艾司氯胺酮

干预措施代码：

Intervention：

Use esketamine before dressing for burns

Intervention code：

组别：

对照组

样本量：

 26

Group：

Control group

Sample size：

干预措施：

烧伤换药前不使用艾司氯胺酮

干预措施代码：

Intervention：

Do not use esketamine before dressing for burns

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

 深圳 

Country：

China

Province：

Guangdong

City：

Shenzhen

单位(医院)：

 深圳市第二人民医院 

单位级别：

 三级甲等 

Institution
hospital：

Shenzhen Second People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

补救药物芬太尼的使用剂量

指标类型：

主要指标

Outcome：

The dosage of the remedy fentanyl

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

苏醒后疼痛评分

指标类型：

次要指标

Outcome：

Pain score after awakening

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

监护下镇静相关并发症发生率

指标类型：

次要指标

Outcome：

Incidence of complications associated with supervised sedation

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

恶心、呕吐发生率

指标类型：

次要指标

Outcome：

Incidence of nausea and vomiting

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

复苏时间

指标类型：

次要指标

Outcome：

The recovery 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：

早期抑郁的发生率

指标类型：

次要指标

Outcome：

Incidence of early depression

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

烧伤科医师操作满意度

指标类型：

次要指标

Outcome：

Operation satisfaction of physicians in the department of burn

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

患者换药满意度

指标类型：

次要指标

Outcome：

Patients' satisfaction with dressing change

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

需要使用芬太尼补救药物患者的比例

指标类型：

次要指标

Outcome：

Percentage of patients requiring fentanyl as a remedy

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

烧伤相关严重并发症发生率

指标类型：

次要指标

Outcome：

Incidence of serious complications associated with burns

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：

Null

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 60 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）：

随机方法采用随机大小区组随机的可变区组随机法，由不参与数据管理的专业统计人员运用统计软件DataWeb数据采集管理系统产生中央随机数列，按照1：1的比例随机分配受试者，随机分为2组。

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

The random method used random large cell group random variable area group random method, by the professional statisticians not involved in data management using statistical software DataWeb data acquisition and management system to generate a central random sequence, according to the ratio of 1:1 randomly assigned

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：

本研究采用双盲，受试者、麻醉操作者、数据采集人员及换药操作者均设盲。宋意护士拆开随机信封，按照分组信息将药物用生理盐水稀释后配置到10ml注射器内，注射器贴上标签（标签上注有受试者编号、姓名、住院号），确认无误后销毁分组信息，并严格执行保密。配置完备的药物交给负责麻醉的操作者，空信封交给数据采集人员。

Blinding：

This study was double-blind, including subjects, anesthesia operators, data collectors and dressing change operators. Nurse Song Yi opened the random envelope, diluted the drugs with normal saline according to the grouping information and filled them into a 10ml syringe. The syringe was labeled (marked with subject number, name and hospitalization number), and the grouping information was destroyed after confirmation, and confidentiality was strictly observed. Fully equipped drugs are given to the anesthesiologist and empty envelopes are given to the data collector.

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

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）：

不共享

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：

本研究采用纸质数据与电子数据库采集方式进行数据管理，研究者根据受试者的原始观察记录，将数据及时、完整、正确的写入病例报告表。患者的姓名首字母缩写、分配号和入院日期都将填入到相应的空格中，病例报告表经主要研究者签字后，及时送临床试验数据保管员。将根据GCP/ICP 指南储存纸质CRF． 数据录入和管理工作委托未参与研究干预的团队人员执行．采用电子数据库系统进行录入、核查。将核查出的问题以及录入过程中遇到的问题或意外情況总结归纳成疑问表，交由研究者解答，直至无数据问题存在．病例报告表在按要求完成数据录人和核查后，召开数据审核会议，在会议上，由主要研究者、临床研究所相关项目负责人．数据管理员和生物统计专业人员对试验数据做出审核．并对数据库检查报告中提出的问题做出决议，并写出数据审核报告。数据库同时将锁定。锁定后的数据文件不再做改动。

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

In this study, paper data and electronic database collection methods were adopted for data management. According to the original observation records of the subjects, the researcher wrote the data into the case report form in a timely, complete and correct manner. The patient's initials, assignment number, and date of admission will be entered in the appropriate blanks, and the case report form will be signed by the principal investigator and sent to the clinical trial data depositary in a timely manner. Paper CRF will be stored according to GCP/ICP guidelines. Data entry and management were delegated to team members not involved in the study intervention. Use electronic database system for input and verification. The problems checked out and the problems or unexpected situations encountered in the input process are summarized into a question list, which is handed over to the researcher to answer until there are no data problems. After the data recording and verification of the case report form as required, a data review meeting will be held, at which the principal investigator and the project leader of the clinical institute will be responsible. Data managers and biometric professionals review the trial data. And make decisions on the problems raised in the database inspection report, and write the data audit report. The database will also be locked. Locked data files are not modified.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-08-31 15:39:24