ChiCTR2500107062 版本V1.0 版本创建时间2025/08/03 11:30:07 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：

ChiCTR2500107062 

最近更新日期：

Date of Last Refreshed on：

2025-08-03 11:28:26 

注册时间：

Date of Registration：

2025-08-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

比较磷丙泊酚二钠、丙泊酚与依托咪酯对急诊脑出血手术患者全身麻醉诱导期血流动力学的影响

Public title：

Comparison of the effects of fospropofol disodium, propofol and etomidate on hemodynamics during general anesthesia induction in patients undergoing emergency intracerebral hemorrhage surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

比较磷丙泊酚二钠、丙泊酚与依托咪酯对急诊脑出血手术患者全身麻醉诱导期血流动力学的影响：一项单中心随机双盲对照试验

Scientific title：

Comparison of the effects of fospropofol disodium, propofol and etomidate on hemodynamics during general anesthesia induction in patients undergoing emergency intracerebral hemorrhage surgery: a single-center randomized double-blind controlled trial

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：

张伯宜 

研究负责人：

高伟 

Applicant：

Zhang Boyi 

Study leader：

Gao Wei 

申请注册联系人电话：

Applicant telephone：

+86 139 9051 3439

研究负责人电话：

Study leader's telephone：

+86 138 3617 2191

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：

zhangbooyii@163.com

研究负责人电子邮件：

Study leader's E-mail：

gaowei20055@126.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：

海南省海口市海南省人民医院

研究负责人通讯地址：

海南省海口市海南省人民医院

Applicant address：

Hainan Provincial People's Hospital, Haikou , Hainan Province

Study leader's address：

Hainan Provincial People's Hospital, Haikou , Hainan 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：

海南省人民医院

Applicant's institution：

Hainan Provincial People's Hospital

研究负责人所在单位：

海南省人民医院

Affiliation of the Leader：

Hainan Provincial People's Hospital

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：

KXXSC2025-IIT-18

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：

海南省人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of Hainan General Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025-06-19 00:00:00

伦理委员会联系人：

陈楠

Contact Name of the ethic committee：

Chen Nan

伦理委员会联系地址：

海南省人民医院信息楼3楼（海南省海口市秀英区秀华路19号）

Contact Address of the ethic committee：

3rd Floor, Information Building, Hainan General Hospital (No. 19, Xiuhua Road, Xiuying District, Haikou City, Hainan Province)

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 898 6862 2476

伦理委员会联系人邮箱：

Contact email of the ethic committee：

hnlunli@126.com

研究实施负责（组长）单位：

海南省人民医院

Primary sponsor：

Hainan Provincial People's Hospital

研究实施负责（组长）单位地址：

海南省海口市海南省人民医院

Primary sponsor's address：

Hainan Provincial People's Hospital, Haikou , Hainan 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)：

海南省

市(区县)：

海口市

Country：

China

Province：

Hainan

City：

Haikou

单位(医院)：

海南省人民医院

具体地址：

海南省海口市海南省人民医院

Institution
hospital：

Hainan Provincial People's Hospital

Address：

Hainan Provincial People's Hospital, Haikou , Hainan Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-selected project (self-funded)

Target disease：

The diagnosis conforms to the diagnostic criteria for cerebral hemorrhage in Chinese Guidelines for the Diagnosis and Treatment of Cerebral Hemorrhage 2019, which is defined as acute onset with neurological deficit symptoms, and the presence of hemorrhage foci shown by cranial CT or MRI; in addition, the patients require emergency surgery under general anesthesia.

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：

以丙泊酚、依托咪酯为对照，观察盐酸注射用磷丙泊酚二钠在急性脑出血患者全身麻醉诱导的有效性与安全性，为临床用药提供更多证据和参考  

Objectives of Study：

With propofol and etomidate as controls, observe the efficacy and safety of fospropofol disodium for injection (hydrochloride) in general anesthesia induction in patients with acute cerebral hemorrhage, so as to provide more evidence and reference for clinical medication.

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)年龄 18~65 岁，性别不限； (2)急诊入院，诊断符合《中国脑出血诊治指南 2019》中ICH的诊断标准[17]，即急性起病,有神经缺 损症状,头颅CT或MRI显示有出血灶； (3)需要在全身麻醉下行急诊手术； (4)入手术室前尚未行气管插管机械通气； (5)美国麻醉医师协会（ASA）： I~IIIE 级； (6)若患者意识清醒且能准确理解该研究，则需患者自愿参加且签署知情同意书；若患者意识不清则需由患者直系亲属或授权委托人充分理解该研究后，签署知情同意书，同意患者参加研究。

Inclusion criteria

(1) Aged 18–65 years, regardless of gender; (2) Emergency admission, with diagnosis conforming to the diagnostic criteria for intracerebral hemorrhage (ICH) in Chinese Guidelines for the Diagnosis and Treatment of Cerebral Hemorrhage 2019 [17], i.e., acute onset, presence of neurological deficit symptoms, and hemorrhage foci shown by cranial CT or MRI; (3) Requiring emergency surgery under general anesthesia; (4) No tracheal intubation and mechanical ventilation performed before entering the operating room; (5) American Society of Anesthesiologists (ASA) physical status: Class I–IIIE; (6) If the patient is conscious and can accurately understand the study, he/she must voluntarily participate and sign the informed consent form; if the patient is unconscious, his/her immediate family members or authorized representatives must fully understand the study, sign the informed consent form, and agree to the patient's participation in the study.

排除标准：

(1)入室即刻开始抢救（如心肺复苏等）或病情极危重患者（ASA分级≥Ⅳ级或MEWS评分≥9分）； (2)明确饱胃患者、存在困难气道或被评定为气管插管困难患者。 (3)器官移植手术患者、心脏手术患者、产科手术患者； (4)有镇静、镇痛药物依赖史、有酗酒、吸毒史； (5)在妊娠期或哺乳期或围手术期 1 个月内有怀孕计划的女性患者； (6) 已知或怀疑对试验药物各种组分或方案中规定的流程化用药(注射用磷丙泊酚二钠、丙泊酚中/长链脂肪乳、依托咪酯注射液、注射用苯磺酸瑞马唑仑、枸橼酸舒芬太尼注射液、注射用苯磺顺阿曲库铵、注射用盐酸瑞芬太尼)过敏或禁忌者； (7)入选本研究前30天内参与了其他临床试验； (8)手术结束后48小时内病房未予以术后查血的； (9)任何原因不能配合或不愿配合本研究； (10)研究者认为不适合参加本研究的情况。

Exclusion criteria：

(1) Patients requiring immediate rescue upon entering the operating room (such as cardiopulmonary resuscitation) or in extremely critical condition (ASA physical status >= Class IV or MEWS score >= 9); (2) Patients with definite full stomach, difficult airway, or those assessed as having difficult tracheal intubation; (3) Patients undergoing organ transplantation, cardiac surgery, or obstetric surgery; (4) Patients with a history of dependence on sedative or analgesic drugs, or a history of alcoholism or drug abuse; (5) Female patients who are pregnant, lactating, or have plans to become pregnant within 1 month of the perioperative period; (6) Patients with known or suspected allergies or contraindications to any components of the study drugs or the standardized medications specified in the protocol (fospropofol disodium for injection, propofol medium/long-chain fat emulsion, etomidate injection, remimazolam besylate for injection, sufentanil citrate injection, cisatracurium besilate for injection, remifentanil hydrochloride for injection); (7) Patients who participated in other clinical trials within 30 days before being enrolled in this study; (8) Patients for whom postoperative blood tests were not performed in the ward within 48 hours after surgery; (9) Patients who cannot cooperate or are unwilling to cooperate with the study for any reason; (10) Any other circumstances deemed inappropriate for participation in the study by the researchers.

研究实施时间：

Study execute time：

从 From 2025-08-03 00:00:00至 To 2026-08-03 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-08-03 00:00:00 至 To 2026-08-03 00:00:00  

干预措施：

Interventions：

组别：

磷丙泊酚二钠组

样本量：

40

Group：

Fospropofol Disodium Group

Sample size：

干预措施：

磷丙泊酚二钠组：患者入室后先以瑞马唑仑0.05mg/kg给予镇静，然后给予其他麻醉诱导药：舒芬太尼0.4μg/kg，磷丙泊酚二钠4mg/kg，顺式阿曲库铵0.2mg/kg（磷丙泊酚二钠在60s内缓慢注射）。根据MOAA/S评分和麻醉深度监测（BIS）值评估插管状态。当患者MOAA/S评分≤1分、且BIS值在50±5时，患者接受气管插管。若给予诱导药5min后患者MOAA/S以及BIS评分无法满足插管，追加2mg/kg磷丙泊酚二钠）。若追加2次后仍无法满足插管条件，患者复合吸入七氟烷（8%）诱导麻醉，并排除本试验。

干预措施代码：

Intervention：

Fospropofol Disodium Group: After entering the operating room, the patient first receives sedation with remimazolam at a dose of 0.05 mg/kg, followed by other anesthetic induction drugs: sufentanil 0.4 μg/kg, fospropofol disodium 4 mg/kg, and cisatracurium 0.2 mg/kg (fospropofol disodium is injected slowly within 60 seconds). The intubation condition is evaluated according to the MOAA/S score and the bispectral index (BIS) for monitoring the depth of anesthesia. Tracheal intubation is performed when the patient's MOAA/S score is <= 1 and the BIS value is within the range of 50 +/- 5. If the patient's MOAA/S score and BIS value still fail to meet the intubation requirements 5 minutes after the administration of induction drugs, an additional 2 mg/kg of fospropofol disodium is given. If the intubation conditions are still not met after two additional doses, the patient is induced with combined inhalation of 8% sevoflurane and excluded from this trial.

Intervention code：

组别：

丙泊酚组

样本量：

40

Group：

Propofol Group

Sample size：

干预措施：

丙泊酚组：患者入室后先以瑞马唑仑0.05mg/kg给予镇静，然后给予其他麻醉诱导药：舒芬太尼0.4μg/kg，丙泊酚1.0mg/kg，顺式阿曲库铵0.2mg/kg（丙泊酚在60s内缓慢注射）。根据MOAA/S评分和麻醉深度监测（BIS）值评估插管状态。当患者MOAA/S评分≤1分、且BIS值在50±5时，患者接受气管插管。若给予诱导药5min后患者MOAA/S以及BIS评分无法满足插管，追加0.5mg/kg丙泊酚）。若追加2次后仍无法满足插管条件，给予患者复合吸入七氟烷（8%）诱导麻醉，并排除本试验。

干预措施代码：

Intervention：

Propofol Group: After entering the operating room, the patient first receives sedation with remimazolam at a dose of 0.05 mg/kg, followed by other anesthetic induction drugs: sufentanil 0.4 μg/kg, propofol 1.0 mg/kg, and cisatracurium 0.2 mg/kg (propofol is injected slowly within 60 seconds). The intubation condition is evaluated according to the MOAA/S score and the bispectral index (BIS) for monitoring the depth of anesthesia. Tracheal intubation is performed when the patient's MOAA/S score is <= 1 and the BIS value is within the range of 50 +/- 5. If the patient's MOAA/S score and BIS value still fail to meet the intubation requirements 5 minutes after the administration of induction drugs, an additional 0.5 mg/kg of propofol is given. If the intubation conditions are still not met after two additional doses, the patient is induced with combined inhalation of 8% sevoflurane and excluded from this trial.

Intervention code：

组别：

依托咪酯组

样本量：

40

Group：

Etomidate Group

Sample size：

干预措施：

患者入室后先以瑞马唑仑0.05mg/kg给予镇静，然后给予其他麻醉诱导药：舒芬太尼0.4μg/kg，依托咪酯0.2mg/kg，顺式阿曲库铵0.2mg/kg（依托咪酯在60s内缓慢注射）。根据MOAA/S评分和麻醉深度监测（BIS）值评估插管状态。当患者MOAA/S评分≤1分、且BIS值在50±5时，患者接受气管插管。若给予诱导药5min后患者MOAA/S以及BIS评分无法满足插管，追加0.1mg/kg依托咪酯）。若追加2次后仍无法满足插管条件，给予患者复合吸入七氟烷（8%）诱导麻醉，并排除本试验。

干预措施代码：

Intervention：

After entering the operating room, the patient first receives sedation with remimazolam at a dose of 0.05 mg/kg, followed by other anesthetic induction drugs: sufentanil 0.4 μg/kg, etomidate 0.2 mg/kg, and cisatracurium 0.2 mg/kg (etomidate is injected slowly within 60 seconds). The intubation condition is evaluated according to the MOAA/S score and the bispectral index (BIS) for monitoring the depth of anesthesia. Tracheal intubation is performed when the patient's MOAA/S score is <= 1 and the BIS value is within the range of 50 +/- 5. If the patient's MOAA/S score and BIS value still fail to meet the intubation requirements 5 minutes after the administration of induction drugs, an additional 0.1 mg/kg of etomidate is given. If the intubation conditions are still not met after two additional doses, the patient is induced with combined inhalation of 8% sevoflurane and excluded from this trial.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 海南省 

市(区县)：

  

Country：

China 

Province：

Hainan 

City：

 

单位(医院)：

海南省人民医院 

单位级别：

三甲 

Institution
hospital：

Hainan Provincial People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

诱导后低血压发病率

指标类型：

主要指标

Outcome：

Incidence of post-induction hypotension

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不同时点的血流动力学指标

指标类型：

次要指标

Outcome：

Hemodynamic parameters at different time points

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血液化验结果

指标类型：

次要指标

Outcome：

Blood test results

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

药物用量：术中血管活性药使用情况

指标类型：

次要指标

Outcome：

Drug dosage: Intraoperative usage of vasoactive drugs

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

恢复质量评分

指标类型：

次要指标

Outcome：

Recovery quality scores

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

麻醉苏醒期出现其他不良反应

指标类型：

次要指标

Outcome：

Other adverse reactions occurring during the anesthesia emergence period

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

苏醒时间

指标类型：

次要指标

Outcome：

Awakening 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：

患者入住ICU时长

指标类型：

次要指标

Outcome：

duration of the patient's ICU 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：

总住院时长

指标类型：

次要指标

Outcome：

total length of hospital stay

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 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）：

由研究者将受试者按1:1：1比例通过计算机生成的区组随机序列分配至磷丙泊酚二钠组、丙泊酚组、依托咪酯组；

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

The researcher will allocate the subjects at a 1:1:1 ratio to the fospropofol disodium group, the propofol group, and the etomidate group according to the block random sequence generated by the computer;

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：

三盲（受试者盲、研究者盲、数据分析者盲）

Blinding：

Triple-blind (blinding of subjects, investigators, and data analysts)

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

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）：

公开日期为：论文发表期刊以后。方式为：研究补充材料（与论文关联）：若研究成果发表在期刊，可将原始数据作为 “补充材料（Supplementary Materials）” 随论文在线发表， 可在期刊平台下载，含详细数据采集、分析流程说明” ，方便读者直接关联论文与数据。

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

The public release date shall be: after the paper is published in the journal. The method is as follows: Research supplementary materials (associated with the paper): If the research results are published in a journal, the original data can be published online as "Supplementary Materials" along with the paper. It can be downloaded on the journal platform and contains detailed descriptions of the data collection and analysis processes", facilitating readers to directly associate the paper with the data.

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：

数据采集和管理由两部分构成。一是病例记录表（CRF），研究人员在此详细记录患者的临床信息，涵盖基本人口学资料（如年龄、性别 ）、术前检查结果（像血压、心率、实验室检验数据 ）、术中麻醉诱导药物给药详情（瑞马唑仑、舒芬太尼、磷丙泊酚二钠 / 丙泊酚 / 依托咪酯、顺式阿曲库铵的剂量及给药时间 ）以及术中血流动力学参数（不同时点的收缩压、舒张压、平均动脉压、心率 ）等。二是电子采集和管理系统（EDC），经授权的工作人员及时将 CRF 上的信息录入 EDC，EDC 具备数据核查（保障数据准确完整，比如检查血流动力学参数记录的逻辑冲突 ）、疑问追踪（记录并解决数据采集过程中出现的疑问 ）、数据存储（安全保存原始数据，供后续统计分析及研究数据共享 ）等功能。通过 CRF 与 EDC 的结合应用，规范数据采集和管理全流程，确保研究数据真实、可靠且可追溯 。

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

Data collection and management consist of two parts. One is the Case Record Form (CRF), where researchers meticulously record clinical information of patients, including basic demographic data (such as age, gender), preoperative examination results (like blood pressure, heart rate, laboratory test data), intraoperative anesthesia induction drug administration details (dosages and administration times of remimazolam, sufentanil, fospropofol disodium/propofol/etomidate, cisatracurium), and intraoperative hemodynamic parameters (SBP, DBP, MAP, HR at different time points). The other is the Electronic Data Capture (EDC) system. Authorized staff input the information from the CRF into the EDC in a timely manner. The EDC supports functions such as data verification (to ensure the accuracy and completeness of data, for example, checking for logical conflicts in hemodynamic parameter records), query tracking (recording and resolving questions about data during the collection process), and data storage (safely storing original data for subsequent statistical analysis and research data sharing). Through the combined application of CRF and EDC, the whole process of data collection and management is standardized, ensuring the authenticity, reliability, and traceability of research data.

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：

  2025-08-03 11:28:26