ChiCTR2300075899 版本V1.1 版本创建时间2024/02/22 18:43:34 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：

 ChiCTR2300075899 

最近更新日期：

Date of Last Refreshed on：

 2023-09-19 11:18:31 

注册时间：

Date of Registration：

 2023-09-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

苯磺酸瑞马唑仑用于日间手术全麻诱导和维持的有效性与安全性

Public title：

Efficacy and safety of remazolam besylate for induction and maintenance of general anesthesia during ambulatory surgeries

注册题目简写：

English Acronym：

研究课题的正式科学名称：

苯磺酸瑞马唑仑用于日间手术全麻诱导和维持的有效性与安全性

Scientific title：

Efficacy and safety of remazolam besylate for induction and maintenance of general anesthesia during ambulatory surgeries

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：

池叶楠 

研究负责人：

董锡臣 

Applicant：

Ye-Nan Chi 

Study leader：

Xi-Chen Dong 

申请注册联系人电话：

Applicant telephone：

 +86 135 8152 6267

研究负责人电话：

Study leader's
telephone：

+86 88001043

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：

 abbie_chiyenan@163.com

研究负责人电子邮件：

Study leader's E-mail：

 gamhdongxc@aliyun.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：

北京市西城区北线阁5号

研究负责人通讯地址：

北京市西城区北线阁5号

Applicant address：

No.5, beixiange, Xicheng District, Beijing

Study leader's address：

No.5, beixiange, Xicheng District, Beijing

申请注册联系人邮政编码：

Applicant postcode：

 100053

研究负责人邮政编码：

Study leader's postcode：

 100053

申请人所在单位：

中国中医科学院广安门医院

Applicant's institution：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

研究负责人所在单位：

中国中医科学院广安门医院

Affiliation of the Leader：

Guang'anmen Hospital, Chinese Academy of Chinese Medicine Sciences

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：

 2023-073-KY-01

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：

中国中医科学院广安门医院伦理委员会

Name of the ethic committee：

Ethic Committee of Guang 'anmen Hospital, China Academy of Chinese Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-06-15 00:00:00

伦理委员会联系人：

乔洁

Contact Name of the ethic committee：

Jie Qiao

伦理委员会联系地址：

北京市西城区北线阁5号

Contact Address of the ethic committee：

No.5, beixiange, Xicheng District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 88001552

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 gamhec@126.com

研究实施负责（组长）单位：

中国中医科学院广安门医院

Primary sponsor：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

研究实施负责（组长）单位地址：

北京市西城区北线阁5号

Primary sponsor's address：

No.5, beixiange, Xicheng District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖北省

市(区县)：

Country：

China

Province：

Hubei

City：

单位(医院)：

宜昌人福药业有限责任公司

具体地址：

湖北省宜昌开发区大连路19号

Institution
hospital：

Yichang Humanwell Pharmaceutical. CO.,LTD.

Address：

19 Dalian Road, Yichang Development Zone, Hubei Province

经费或物资来源：

企业

Source(s) of funding：

company

研究疾病：

日间手术  

Target disease：

ambulatory surgeries

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：

评价苯磺酸瑞马唑仑用于日间手术全麻诱导和维持的有效性及不良反应  

Objectives of Study：

To evaluate the efficacy and adverse reactions of remazolam besylate for induction and maintenance of general anesthesia during ambulatory surgeries

药物成份或治疗方案详述：

试验组：麻醉诱导期，苯磺酸瑞马唑仑6mg/kg/h+舒芬太尼0.2-0.4μg/kg，麻醉维持期，苯磺酸瑞马唑仑0.5-1.5mg/kg/h+瑞芬太尼0.2-0.4μg/kg/min。 对照组：麻醉诱导期，丙泊酚注射液2mg/kg+舒芬太尼0.2-0.4μg/kg，麻醉维持期，丙泊酚6-12mg/kg/h和瑞芬太尼0.2-0.4μg/kg/min。  

Description for medicine or protocol of treatment in detail：

Experimental group: During anesthesia induction, remazolam besylate was 6mg/kg/h+ sufentanil 0.2-0.4μg/kg; during anesthesia maintenance, remazolam besylate was 0.5-1.5mg/kg/h+ remfentanil 0.2-0.4μg/kg/min. Control group: anesthetic induction period, propofol injection 2mg/kg+ sufentanil 0.2-0.4μg/kg; anesthetic maintenance period, propofol 6-12mg/kg/h and remifentanil 0.2-0.4μg/kg/min. 

纳入标准：

(1)行择期日间手术，需行全身麻醉的患者； (2)年龄18-65周岁，性别不限； (3)美国麻醉医师协会ASAⅠ-Ⅱ级； (4)体重指数BMI 18-29 kg/m2； (5)手术时间预计小于2h的非急诊手术； (6)患者自愿参加该试验，并签署知情同意书。

Inclusion criteria

(1) Patients undergoing elective day surgery requiring general anesthesia; (2) Age 18-65 years old, gender is not limited; (3) American Society of Anesthesiologists ASA Class I-II; (4) Body mass index 18-29 kg/m2; (5) Non-emergency surgery whose operation time is expected to be less than 2 hours; (6) The patient voluntarily participated in the trial and signed the informed consent.

排除标准：

(1) 受试者明确拒绝参与本研究； (2) 具有深度镇静/全身麻醉禁忌症者或既往曾出现过镇静/麻醉意外史者； (3) 已知对鸡蛋、豆制品、阿片类药物及其解救药、丙泊酚、苯磺酸瑞马唑仑等过敏者；丙泊酚、苯二氮卓类药物、阿片类药物及其解救药禁忌症者； (4) 患有严重的肝脏、肾脏、消化系统、血液系统、神经肌肉系统或代谢系统等研究者判断可能增加镇静/麻醉风险而不适合参加研究的疾病史； (5) 有慢性疼痛长期使用镇痛药、精神系统药物(包括阿片, NSAIDs, 镇静药, 抗抑郁药)、酒精滥用者，怀疑有滥用麻醉性镇痛药或镇静药者； (6) 筛选期发现以下呼吸道管理风险： a） 哮喘史、喘鸣； b） 睡眠呼吸暂停综合征者； c） 有恶性高热病史或家族史； d） 有气管插管失败经历者； e） 2周内有呼吸道急性炎症且未治愈病史； f） 患有食道返流症； g） 筛选时经研究者判断存在困难气道或被判定为气管插管困难（改良马氏评分为Ⅳ级）； (7) 筛选前1个月内参加过任何药物临床试验者；诊疗前3天有阿片类药物和镇静/麻醉药物使用的患者； (8) 孕妇或产妇； (9) 心电图提示：心率<50次/min； (10) 十五日内服用过单胺氧化酶抑制药物或抗抑郁药物； (11) 研究者认为具有任何其他不宜参加此临床研究因素的受试者。

Exclusion criteria：

(1) The subject explicitly refuses to participate in the study; (2) Those who have contraindications to deep sedation/general anesthesia or have a history of sedation/anesthesia accidents in the past; (3) People who are known to be allergic to eggs, soy products, opioids and their relief drugs, propofol, remazolam benzoate, etc.; Propofol, benzodiazepines, opioids and their relief drugs contraindicated; (4) A history of severe liver, kidney, digestive, hematological, neuromuscular, or metabolic disease that the investigator judges may increase the risk of sedation/anesthesia and is not suitable for study participation; (5) Chronic pain, chronic use of analgesics, psychotropic drugs (including opioids, NSAIDs, sedatives, antidepressants), alcohol abuse, suspected abuse of narcotic analgesics or sedatives; (6) The following respiratory management risks were found during the screening period: a) History of asthma, wheezing; b) Patients with sleep apnea syndrome; c) A history or family history of malignant hyperthermia; d) Patients with tracheal intubation failure; e) A history of acute respiratory inflammation within 2 weeks with no cure; f) suffering from esophageal reflux disease; g) Difficult airway identified by the investigator or difficult intubation of the trachea during screening (modified Markov score level Ⅳ); (7) Participants in any drug clinical trial within 1 month before screening; Patients with opioid and sedative/narcotic use in the 3 days prior to treatment; (8) Pregnant women or women giving birth; (9) Electrocardiogram: heart rate <50 beats /min; (10) Taking monoamine oxidase inhibitors or antidepressants within 15 days; (11) Subjects who have any other factors deemed unsuitable for participation in this clinical study by the investigator.

研究实施时间：

Study execute time：

从 From 2022-11-01 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-10-01 00:00:00 至 To 2024-12-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 90

Group：

experimental group

Sample size：

干预措施：

麻醉诱导：苯磺酸瑞马唑仑6mg/kg/h；追加剂量2mg/kg/h； 麻醉维持：苯磺酸瑞马唑仑输注速率在0.5-1.5 mg/kg/h间调节。手术结束前停止给药。

干预措施代码：

Intervention：

Anesthesia induction: Remazolam besylate 6mg/kg/h; Supplemental dose 2mg/kg/h; Anesthesia maintenance: The infusion rate of remazolam besylate is adjusted between 0.5-1.5 mg/kg/h. Stop dosing until the end of the procedure.

Intervention code：

组别：

对照组

样本量：

 90

Group：

control group

Sample size：

干预措施：

麻醉诱导：丙泊酚2mg/kg；追加剂量0.5mg/kg 麻醉维持：丙泊酚推荐剂量范围为 6~12 mg/kg/h；手术结束时停止给药。维持期瑞芬太尼推荐剂量为 0.2~0.4μg/kg/min，手术结束时停止输注；肌松药维持肌松；手术结束前约 30 min，进行术后镇痛预处理；

干预措施代码：

Intervention：

Induction of anesthesia: propofol 2mg/kg; Supplemental dose 0.5mg/kg Anesthetic maintenance: The recommended dosage range of propofol is 6-12 mg/kg/h. Stop dosing at the end of the procedure. The recommended dose of remifentanil during maintenance is 0.2-0.4 μg/kg/min, and the infusion should be stopped at the end of surgery. Muscle relaxants maintain muscle relaxants; About 30 minutes before the end of the operation, postoperative analgesia pretreatment was performed.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 中国中医科学院广安门医院 

单位级别：

 三甲 

Institution
hospital：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

麻醉诱导和维持成功的比例

指标类型：

主要指标

Outcome：

The proportion of successful induction and maintenance of anesthesia

Type：

Primary indicator

测量时间点：

术毕

测量方法：

判定为成功需同时满足以下 2 个标准： 1）麻醉诱导成功（受试者MOAA/S 评分≤1且未使用补救镇静药物）； 2）麻醉维持成功（维持期无因镇静不足导致的躯体活动且未使用补救镇静药物）；

Measure time point of outcome：

after the surgeries

Measure method：

To be considered successful, the following two criteria must be met: 1) Successful induction of anesthesia (subject MOAA/S score ≤1 and no remedial sedation drugs were used); 2) Successful maintenance of anesthesia (no physical activity caused by insufficient sedation and no remedial sedation drugs were used during the maintenance period);

指标中文名：

生命体征

指标类型：

次要指标

Outcome：

vital signs

Type：

Secondary indicator

测量时间点：

T0: 给药（瑞马唑仑或丙泊酚）前 （2）T1：给药后1min （3）T2: 气管插管前 （4）T3: 气管插管时 （5）T4: 插管后1min （6）T5: 插管后3min （7）T6：插管后5min （8）T7：插管后10min （9）T8：插管后15min （10）T9：插管后20min （11）T10：插管后30min （12）T11：睁眼时 （13）T12：拔管时 （14）T13：拔管后2min （15）T14：拔管后4min （16）T15：术后24h

测量方法：

血压、心率、脉氧饱和度、呼气末二氧化碳分压、呼吸频率

Measure time point of outcome：

T0: Before administration (Remazolam or propofol) (2) T1:1min after administration (3) T2: Before tracheal intubation (4) T3: During endotracheal intubation (5) T4: 1min after intubation (6) T5: 3 minutes after intubation (7) T6:5 minutes after intubation (8) T7:10min after intubation (9) T8:15min after intubation (10) T9:20 minutes after intubation (11) T10:30min after intubation (12) T11: When the eyes open (13) T12: When extubation (14) T13:2min after extubation (15) T14:4 minut

Measure method：

BP,HR,SpO2,PetCO2,RR

指标中文名：

有效性指标

指标类型：

附加指标

Outcome：

effectiveness index

Type：

Additional indicator

测量时间点：

术中

测量方法：

开始给药至受试者意识丧失的时间；总手术时间；苏醒时间；给药结束至拔管时间；受试者苏醒至离开手术室时间； 瑞马唑仑、丙泊酚总用量；麻醉诱导期和手术中追加给药次数及剂量； 术中知晓的发生率；Ramsay镇静评分；

Measure time point of outcome：

during the surgeries

Measure method：

The time between initiation of administration and subject's loss of consciousness; Total operating time; Time of recovery; Time from the end of administration to extubation; The time when subjects woke up and left the operating room; Total dosage of remazolam and propofol; The number and dosage of additional administration during anesthesia induction and operation; Intraoperative known incidence; Ramsay sedation score;

指标中文名：

不良事件/不良反应

指标类型：

副作用指标

Outcome：

Number and dose of adverse events/reactions

Type：

Adverse events

测量时间点：

术中

测量方法：

低氧饱和度、气道梗阻、呼吸抑制、呼吸暂停、心动过缓、心动过速、术中知晓、术中使用升压药物的次数和剂量；术中使用阿托品的次数和剂量；

Measure time point of outcome：

during the surgeries

Measure method：

Low oxygen saturation, airway obstruction, respiratory depression, apnea, bradycardia, tachycardia, intraoperative awareness, intraoperative use of pressor and dose; The number and dosage of atropine used during the operation;

指标中文名：

满意度评分

指标类型：

附加指标

Outcome：

satisfaction scores

Type：

Additional indicator

测量时间点：

术毕

测量方法：

患者满意度；麻醉医生满意度；手术医生满意度；

Measure time point of outcome：

after the surgeries

Measure method：

Patient satisfaction; Anesthesiologist satisfaction; Surgeon satisfaction;

指标中文名：

术后24h不良反应

指标类型：

副作用指标

Outcome：

Adverse reactions 24 hours after surgery

Type：

Adverse events

测量时间点：

术后24h

测量方法：

术后24h不良反应（包括恶心、呕吐、头晕、头昏、头痛、嗜睡、乏力、腹胀、腹痛、嗳气等）

Measure time point of outcome：

24 hours after surgery

Measure method：

nausea, vomiting, dizziness, dizziness, headache, lethargy, fatigue, abdominal distension, abdominal pain, belching, etc.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

不涉及

组织：

Sample Name：

None

Tissue：

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 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）：

运用统计软件SPSS21.0，按计划的受试者总例数、组别数，组间比例、区组长度随机生成随机编码表。随机表（盲底）密封保存，由给药研究者保存。

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

Statistical software SPSS21.0 was used to randomly generate a random coding table based on the total number of subjects, number of groups, proportion between groups and block length as planned. The random table (blind bottom) is sealed and kept by the dosing investigator.

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：

因本次研究试验药物苯磺酸瑞马唑仑（粉针）和对照药丙泊酚（白色乳状液体）外观差距大，无法对给药者设盲，因此，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。给药研究者仅负责给药，不参与后续数据收集及数据统计；本试验对患者和评价研究者是双盲设计。

Blinding：

Due to the large difference in appearance between the experimental drug Remazolam benzosulfonate (powder needle) and the control drug propofol (white milky liquid), it is impossible to blind the drug giver. Therefore, the evaluation researcher and the drug giver were set up in this study, and only the evaluation researcher was blind. Drug administration researchers are only responsible for drug administration, and do not participate in follow-up data collection and data statistics. The trial was double-blinded for both patients and evaluators.

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年12月以后经研究者同意后共享

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

It will not be shared with the consent of the researcher till December 2026.

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.建立数据库：由承担本研究的统计单位，负责建立数据库及全部数据的录入工作，采用 RESMAN电子化数据管理系统进行数据管理工作，数据管理员根据研究方案、CRF构建数据库，同时对数据有效性进行逻辑核查设置，并对研究者和监查员开放系统访问权限，以便核查数据和解答疑问。 2.数据录入与双份核查：临床研究过程中，应实时（分批）将CRF送交数据管理单位，数据管理员进行独立双份录入，并进行双份核查，对录入不一致的结果，对照CRF逐项核查、更正。再随机抽取若干份病例报告表和数据库中的数据进行人工比较，以确保数据库中的数据与原始CRF表中的结果一致。 数据录入同时系统自动发出疑问，如日期、入组标准、排除标准、脱落、缺失值等，特别对统计分析的重要指标利用计算机程序进行详细检查，研究者可直接在线答疑并签名后，再统一由研究助理录入系统，离线答疑表在各研究中心妥善保管。对于系统疑问，研究者应尽快予以解答，答疑后数据必要时可再次发出疑问。 3.数据审核与数据库锁定：系统中所有数据疑问解决后，“清洁”数据导出，交统计人员，由主要研究者、申办者、统计分析人员对数据进行数据审核，同时定稿统计计划书。数据盲态核查报告和统计计划书定稿后，锁定数据，并按统计分析计划进行统计分析。

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

1. Build a database: The statistical unit responsible for this study is responsible for the establishment of the database and the entry of all data. The RESMAN electronic data management system is adopted for data management. The data manager constructs the database according to the research scheme and CRF, and at the same time, the logical verification and setting of data validity are carried out, and the access rights of the system are opened to researchers and inspectors. To verify data and answer questions. 2. Data entry and double verification: In the process of clinical study, CRF should be sent to the data management unit in real time (in batches), and the data manager should conduct independent double entry and double verification, and check and correct the inconsistencies against CRF item by item. A number of case report forms were randomly selected and manually compared with the data in the database to ensure that the data in the database was consistent with the results in the original CRF table. At the same time of data entry, the system automatically issues questions, such as date, inclusion criteria, exclusion criteria, drop off, missing value, etc. In particular, the important indicators of statistical analysis are checked in detail by computer programs. Researchers can directly answer questions online and sign them, and then the research assistant will enter them into the system. For questions about the system, the researcher should answer them as soon as possible, and after answering the questions, the data can be asked again if necessary. 3. Data review and database locking: After solving all data questions in the system, the "clean" data is exported and handed over to statisticians. The data is reviewed by the main researchers, sponsors and statistical analysts, and the statistical plan is finalized at the same time. After the data blind verification report and statistical plan are finalized, the data is locked and analyzed according to the statistical analysis plan.

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：

  2023-09-19 11:18:26