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苯磺酸瑞马唑仑与丙泊酚用于高血压患者全身麻醉的随机对照研究
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注册号：

Registration number：

 ChiCTR2600117697 

最近更新日期：

Date of Last Refreshed on：

 2026-01-27 18:28:20 

注册时间：

Date of Registration：

 2026-01-27 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

苯磺酸瑞马唑仑与丙泊酚用于高血压患者全身麻醉的随机对照研究

Public title：

A Randomized Controlled Trial Comparing Remimazolam Besylate with Propofol in Hypertensive Patients Undergoing General Anesthesia

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高血压患者行腹腔镜手术中的麻醉效果与对血流动力学影响的随机对照研究

Scientific title：

A Randomized Controlled Trial on the Anesthetic Efficacy and Hemodynamic Effects of Remimazolam Besylate in Hypertensive Patients Undergoing Laparoscopic Surgery

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：

张毓婷 

研究负责人：

白栓成 

Applicant：

Zhang Yuting 

Study leader：

Bai Shuancheng 

申请注册联系人电话：

Applicant telephone：

 +86 136 9472 7968

研究负责人电话：

Study leader's
telephone：

+86 133 4718 8900

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：

 1411337021@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 mzkbsc@sina.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：

内蒙古自治区包头市东河区环城路61号

研究负责人通讯地址：

内蒙古自治区包头市东河区环城路61号

Applicant address：

No.61,Huancheng Road, Donghe District, Baotou City, Inner Mongolia Autonomous Region

Study leader's address：

No.61,Huancheng Road, Donghe District, Baotou City, Inner Mongolia Autonomous Region

申请注册联系人邮政编码：

Applicant postcode：

 014040

研究负责人邮政编码：

Study leader's postcode：

 014040

申请人所在单位：

包头市中心医院

Applicant's institution：

Baotou Central Hospital

研究负责人所在单位：

包头市中心医院

Affiliation of the Leader：

Baotou Central 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：

 KYLL2024(伦)081号

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：

包头市中心医院伦理委员会

Name of the ethic committee：

Ethics Committee of Baotou Central Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-07-02 00:00:00

伦理委员会联系人：

张丽香

Contact Name of the ethic committee：

Zhang Lixiang

伦理委员会联系地址：

内蒙古自治区包头市东河区环城路61号

Contact Address of the ethic committee：

No.61,Huancheng Road, Donghe District, Baotou City, Inner Mongolia Autonomous Region

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 472 695 5528

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：

包头市中心医院

Primary sponsor：

Baotou Central Hospital

研究实施负责（组长）单位地址：

内蒙古自治区包头市东河区环城路61号

Primary sponsor's address：

No.61,Huancheng Road, Donghe District, Baotou City, Inner Mongolia Autonomous Region

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

内蒙古自治区

市(区县)：

包头市

Country：

China

Province：

Inner Mongolia Autonomous Region

City：

Baotou City

单位(医院)：

包头市中心医院

具体地址：

内蒙古自治区包头市东河区环城路61号

Institution
hospital：

Baotou Central Hospital

Address：

No.61,Huancheng Road, Donghe District, Baotou City, Inner Mongolia Autonomous Region

经费或物资来源：

中关村精准医学基金会

Source(s) of funding：

Zhongguancun Precision Medicine Foundation

研究疾病：

高血压  

Target disease：

Hypertension

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究旨在探讨苯磺酸瑞马唑仑与丙泊酚在高血压患者接受腹腔镜手术时进行全身麻醉诱导和维持中的有效性、安全性及血流动力学稳定性的比较，为临床麻醉制定更加安全、有效的麻醉方案提供依据。本研究的开展对于高血压患者在围术期减少心脑血管等不良事件的发生、改善患者手术预后具有重要意义。通过本研究，我们期望能够为苯磺酸瑞马唑仑在高血压患者中的广泛应用提供有力证据，改善高血压患者的麻醉管理和手术预后。  

Objectives of Study：

This study aims to compare the efficacy, safety and hemodynamic stability of remimazolam besylate and propofol in the induction and maintenance of general anesthesia in hypertensive patients undergoing laparoscopic surgery, providing a basis for the formulation of safer and more effective anesthesia protocols in clinical practice. The implementation of this study is of great significance for reducing the occurrence of adverse events such as cardiovascular and cerebrovascular events in hypertensive patients during the perioperative period and improving the surgical prognosis of patients. Through this study, we hope to provide strong evidence for the wide application of remimazolam besylate in hypertensive patients, and improve the anesthesia management and surgical prognosis of hypertensive patients.

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.受试者明确拒绝参与本研究； 2.对苯二氮䓬药物、阿片药物等研究药物过敏或有禁忌者； 3.术前原发性高血压未得到有效控制（收缩压>180mmHg和（或）舒张压>110mmHg）者； 4.继发性高血压患者（如肾性高血压、内分泌性高血压）； 5.2周内有呼吸道急性炎症且未治愈病史； 6.术前合并重要器官功能不全者（如心功能不全、肺功能不全、肝肾功能不全等）； 7.术前存在糖尿病史者； 8.术前存在冠心病史者； 9.长期服用（滥用）精神类药物或认知功能障碍者； 10.术前3个月内有激素或免疫抑制剂服用史； 11.术前３个月内参加过药物临床试验者； 12.临床检查资料不齐全者； 13.研究者认为不宜参加本研究的受试者。

Exclusion criteria：

1.The subjects explicitly refused to participate in this study; 2.Those who are allergic to or have contraindications to benzodiazepine drugs, opioid drugs, and other investigational drugs; 3.Those whose primary hypertension was not effectively controlled before the surgery (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg); 4.Secondary hypertension patients (such as renal hypertension, endocrine hypertension); 5.Patients with acute respiratory inflammation within 2 weeks and a history of unhealed condition; 6.Those with preoperative significant organ dysfunction (such as cardiac insufficiency, pulmonary insufficiency, liver and kidney dysfunction, etc.); 7.Those with a history of diabetes before the surgery; 8.Those with a history of coronary heart disease before the surgery; 9.Those who have been taking (abusing) psychotropic drugs for a long time or have cognitive dysfunction; 10.Those who have taken hormones or immunosuppressants within 3 months before the surgery; 11.Those who have participated in drug clinical trials within 3 months before the surgery; 12.Those with incomplete clinical examination data; 13.Those considered by the researchers to be unsuitable to participate in this study.

研究实施时间：

Study execute time：

从 From 2024-10-01 00:00:00至 To 2026-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-10-15 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：

丙泊酚组

样本量：

 50

Group：

Propofol group

Sample size：

干预措施：

在全身麻醉诱导与维持阶段，丙泊酚组选取丙泊酚用于镇静；两组全麻药物除镇静药以外其他用药（如镇痛药、肌松药以及备用抢救药品等）均保持一致。

干预措施代码：

Intervention：

During the induction and maintenance phases of general anesthesia, propofol was selected for sedation in the propofol group; the other medications (such as analgesics, muscle relaxants, and emergency rescue drugs, etc.) used in both groups for general anesthesia were kept the same except for the sedative drugs.

Intervention code：

组别：

瑞马唑仑组

样本量：

 50

Group：

Remimazolam group

Sample size：

干预措施：

在全身麻醉诱导与维持阶段，瑞马唑仑组选取苯磺酸瑞马唑仑用于镇静；两组全麻药物除镇静药以外其他用药（如镇痛药、肌松药以及备用抢救药品等）均保持一致。

干预措施代码：

Intervention：

During the induction and maintenance phases of general anesthesia, the remimazolam group used sarazolam phosphate for sedation; the other medications (such as analgesics, muscle relaxants, and emergency rescue drugs, etc.) administered in both groups were kept the same except for the sedative drugs.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 内蒙古自治区 

市(区县)：

 包头市 

Country：

China

Province：

Inner Mongolia Autonomous Region

City：

Baotou City

单位(医院)：

 包头市中心医院 

单位级别：

 三甲 

Institution
hospital：

Baotou Central Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

平均动脉压（MAP）

指标类型：

主要指标

Outcome：

Mean Arterial Pressure (MAP)

Type：

Primary indicator

测量时间点：

入室后静息10min时(T0)、全麻诱导完成后1min时(T1)、气管插管即时(T2)、手术开始30min时(T3)、术毕时(T4)、气管导管拔出时(T5)

测量方法：

监护仪袖带测压

Measure time point of outcome：

After entering the room, at rest for 10 minutes (T0), 1 minute after the completion of general anesthesia induction (T1), immediately after tracheal intubation (T2), 30 minutes after the start of the surgery (T3), at the end of the surgery (T4), and when the tracheal tube is removed (T5)

Measure method：

Monitoring cuff blood pressure measurement

指标中文名：

心率（HR）

指标类型：

主要指标

Outcome：

Heart rate (HR)

Type：

Primary indicator

测量时间点：

入室后静息10min时(T0)、全麻诱导完成后1min时(T1)、气管插管即时(T2)、手术开始30min时(T3)、术毕时(T4)、气管导管拔出时(T5)

测量方法：

监护仪心电图

Measure time point of outcome：

After entering the room, at rest for 10 minutes (T0), 1 minute after the completion of general anesthesia induction (T1), immediately after tracheal intubation (T2), 30 minutes after the start of the surgery (T3), at the end of the surgery (T4), and when the tracheal tube is removed (T5)

Measure method：

Monitoring machine electrocardiogram

指标中文名：

外周血氧饱和度（SpO2）

指标类型：

主要指标

Outcome：

Peripheral Oxygen Saturation (SpO2)

Type：

Primary indicator

测量时间点：

入室后静息10min时(T0)、全麻诱导完成后1min时(T1)、气管插管即时(T2)、手术开始30min时(T3)、术毕时(T4)、气管导管拔出时(T5)

测量方法：

监护仪血氧夹

Measure time point of outcome：

After entering the room, at rest for 10 minutes (T0), 1 minute after the completion of general anesthesia induction (T1), immediately after tracheal intubation (T2), 30 minutes after the start of the surgery (T3), at the end of the surgery (T4), and when the tracheal tube is removed (T5)

Measure method：

Oxygen monitor clip

指标中文名：

脑电双频指数(BIS)

指标类型：

主要指标

Outcome：

Bispectral Index of Electroencephalogram (BIS)

Type：

Primary indicator

测量时间点：

入室后静息10min时(T0)、全麻诱导完成后1min时(T1)、气管插管即时(T2)、手术开始30min时(T3)、术毕时(T4)、气管导管拔出时(T5)

测量方法：

脑电监测 TCI 注射泵

Measure time point of outcome：

After entering the room, at rest for 10 minutes (T0), 1 minute after the completion of general anesthesia induction (T1), immediately after tracheal intubation (T2), 30 minutes after the start of the surgery (T3), at the end of the surgery (T4), and when the tracheal tube is removed (T5)

Measure method：

Electroencephalogram monitoring, TCI infusion pump

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 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）：

本实验研究人员采用随机数字法将患者按照1:1比例随机分到瑞马唑仑组和丙泊酚组中，每组各50人。具体操作方法为：利用Excel软件首先为所有患者按入组顺序依次编号1~100；随后用RAND函数生成 100 个 0~1 之间的随机数，为每例患者匹配唯一随机数；再将随机数进行升序排序，排序后前 50 例患者纳入瑞马唑仑组，后 50 例患者纳入丙泊酚组。

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

In this experiment, researchers randomly assigned patients to the remimazolam group and the propofol group in a 1:1 ratio using the random number method, with 50 patients in each group. The specific operation method is as follows: First, use Excel software to number all patients in sequence from 1 to 100 according to the order of enrollment. Subsequently, the RAND function is used to generate 100 random numbers between 0 and 1, and a unique random number is matched for each patient. The random numbers were then sorted in ascending order. After sorting, the top 50 patients were included in the remimazolam group, and the bottom 50 patients were included in the propofol group.

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：

单盲：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，本研究仅对受试者设盲，使受试者不知道其所接受的是哪种干预措施。

Blinding：

Single-blind: The subjects are kept blinded, so that they are unaware of which intervention they are receiving.

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

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6月；http://www.medresman.org

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

June 2026;http://www.medresman.org

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：

本研究实验工作已完成实施，目前正处于实验数据的整理、核查与统计分析阶段。为保障数据的准确性、完整性与规范性，团队正严格按照研究方案和数据管理规范开展统计学检验等工作，确保分析结果科学可靠。待实验全流程完成并形成最终分析结论后，预计在实验结题后的 6 个月内，将本研究的相关原始数据、分析数据集及数据说明文档上传至指定共享平台，供科研同行查阅、验证与二次研究使用，切实践行科研数据开放共享的原则。

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

The experimental work of this research has been completed and implemented. Currently, it is in the stage of organizing, verifying and statistically analyzing the experimental data. To ensure the accuracy, completeness and standardization of the data, the team is strictly conducting statistical tests and other work in accordance with the research plan and data management norms to ensure that the analysis results are scientific and reliable. After the entire experimental process is completed and the final analysis conclusion is formed, it is expected that within six months after the conclusion of the experiment, the relevant original data, analysis datasets and data description documents of this research will be uploaded to the designated sharing platform for review, verification and secondary research use by fellow researchers, truly practicing the principle of open sharing of scientific 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：

  2026-01-27 18:28:00
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