ChiCTR2500102673 版本V1.0 版本创建时间2025/05/19 09:45:46 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：

ChiCTR2500102673 

最近更新日期：

Date of Last Refreshed on：

2025-05-19 09:45:40 

注册时间：

Date of Registration：

2025-05-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

奥赛利定、艾司氯胺酮和舒芬太尼对宫腔镜手术患者呼吸系统不良事件的比较： 一项前瞻性、随机对照试验

Public title：

Comparison of respiratory adverse events of oliceridine, esketamine and sufentanil in hysteroscopy :a prospective, randomized, controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

奥赛利定、艾司氯胺酮和舒芬太尼对宫腔镜手术患者呼吸系统不良事件的比较： 一项前瞻性、随机对照试验

Scientific title：

Comparison of respiratory adverse events of oliceridine, esketamine and sufentanil in hysteroscopy :a prospective, randomized, 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：

叶林阳 

研究负责人：

叶林阳 

Applicant：

YE Linyang 

Study leader：

YE Linyang 

申请注册联系人电话：

Applicant telephone：

+86 136 9501 6899

研究负责人电话：

Study leader's telephone：

+86 136 9501 6899

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：

1927484131@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1927484131@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：

厦门大学附属第一医院

研究负责人通讯地址：

厦门大学附属第一医院

Applicant address：

The First Affiliated Hospital of Xiamen University

Study leader's address：

The First Affiliated Hospital of Xiamen University

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：

厦门大学附属第一医院

Applicant's institution：

The First Affiliated Hospital of Xiamen University

研究负责人所在单位：

厦门大学附属第一医院

Affiliation of the Leader：

The First Affiliated Hospital of Xiamen University

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：

[2025]科研伦审字(077)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：

厦门大学附属第一医院临床研究伦理委员会

Name of the ethic committee：

Clinical Research Ethics Committee of the First Affiliated Hospital of Xiamen University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-05-15 00:00:00

伦理委员会联系人：

厦门大学附属第一医院曹老师

Contact Name of the ethic committee：

The First Affiliated Hospital of Xiamen University

伦理委员会联系地址：

厦门市镇海路55号厦门大学附属第一医院

Contact Address of the ethic committee：

No. 55 Zhenhai Road, Siming District, Xiamen City, Fujian Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 592 213 7569

伦理委员会联系人邮箱：

Contact email of the ethic committee：

xdfyec@sina.com

研究实施负责（组长）单位：

厦门大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of Xiamen University

研究实施负责（组长）单位地址：

厦门市镇海路55号厦门大学附属第一医院

Primary sponsor's address：

No. 55 Zhenhai Road, Siming District, Xiamen City, Fujian 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)：

福建省

市(区县)：

厦门市

Country：

China

Province：

Fujian Province

City：

Xiamen City

单位(医院)：

厦门大学附属第一医院

具体地址：

厦门市镇海路55号厦门大学附属第一医院

Institution
hospital：

The First Affiliated Hospital of Xiamen University

Address：

No. 55 Zhenhai Road, Siming District, Xiamen City, Fujian Province

经费或物资来源：

无

Source(s) of funding：

none

Target disease：

Endometrial polyps

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

探索奥赛利定、艾司氯胺酮和舒芬太尼用于日间宫腔镜手术的ED95，并比较奥赛利定、艾司氯胺酮和舒芬太尼用于日间宫腔镜手术的有效性和安全性，寻找日间宫腔镜手术保留自主呼吸静脉麻醉更加安全、有效、舒适的麻醉镇痛药。遵循快速康复理念，优化麻醉方法及用药，减少患者围手术期麻醉插管等刺激带来的伤害，减轻患者住院期间的经济压力，提高患者围手术期安全性和舒适性。同时，加快医院病床周转率及手术流转率，提高医疗资源利用率。  

Objectives of Study：

Explore the ED95 of using oliceridine, esketamine and sufentanil for daytime hysteroscopy surgery, and compare the effectiveness and safety of using oliceridine, esketamine and sufentanil for daytime hysteroscopy surgery, in order to find a safer, more effective, and comfortable anesthesia analgesic that preserves autonomous breathing for daytime hysteroscopy surgery. Following the concept of rapid recovery, optimizing anesthesia methods and medication, reducing the harm caused by anesthesia intubation and other stimuli during the perioperative period, alleviating the economic pressure on patients during hospitalization, and improving the safety and comfort of patients during the perioperative period. At the same time, accelerate the turnover rate of hospital beds and surgical procedures, and improve the utilization rate of medical resources.

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)所有患者均行择期日间宫腔镜子宫内膜息肉摘除手术，预计手术时间≤20分钟； (2)年龄在18-64岁，ASA分级在I～Ⅱ级； (3)具备正常沟通能力并能配合的患者； (4)BMI为18.5-24.0，且体重小于65kg。

Inclusion criteria

(1)All patients underwent elective daytime hysteroscopic endometrial polypectomy surgery, with an estimated surgery time of ≤ 20 minutes. (2)Age is between 18 and 64 years old, and American Society of Anesthesiologists (ASA) physical status of I or II. (3)Patients have normal communication skills and the ability to cooperate. (4)BMI is between18.5 and 24.0 and weight is less than 65kg.

排除标准：

（1）对术中任一药物过敏者； （2）术前有酗酒、阿片类及艾司氯胺酮等药物滥用史； （3） Mallampati 气道分级≥3 级或存在OSAS、中重度限制性、阻塞性通气功能障碍、哮喘及肺动脉高压等严重呼吸系统疾病； （4）严重心、肝、脑、肾疾病，如严重高血压（收缩压≥160mmHg 或舒张压≥100mmHg）、大血管动脉瘤、脑出血等重要脏器损害； （5）心电图提示心动过缓（HR＜60 次/分）、Ⅱ或Ⅲ度房室传导阻滞、QT间期延长等； （6）胃肠道手术史（1-2cm胃肠息肉圈套切除及小于0.5 cm微小胃肠息肉组织采取活检钳钳除除外，余息肉术史不参与此次研究）、胃食管反流病史（自述反酸烧心症状患者以及胃镜检查确诊患者）、消化道梗阻； （7）精神疾患及沟通困难、无法配合者。 （8）研究中拒不配合或因个人原因选择退出的患者； （9）因手术要求需更改手术方式者； （10）研究过程中发生与研究药物无关的严重的不良事件不能入组者或意外事件者； （11）因各种原因失访的患者； （12）其他。

Exclusion criteria：

(1) Individuals who are allergic to any medication during surgery; (2) History of alcohol abuse, opioid and ketamine abuse before surgery; (3) Mallampati airway grade is equal or greater than 3 or patient have severe respiratory diseases such as OSAS, moderate to severe restrictive, obstructive ventilation dysfunction, asthma, and pulmonary arterial hypertension; (4) Serious heart, liver, brain, and kidney diseases, such as severe hypertension (systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 100mmHg), large vessel aneurysms, cerebral hemorrhage, and other important organ damage; (5) Electrocardiogram indicates bradycardia (HR<60 beats/minute), second or third degree atrioventricular block, QT interval prolongation, etc; (6) History of gastrointestinal surgery (excluding resection of 1-2cm gastrointestinal polyps and removal of small gastrointestinal polyps less than 0.5 cm using biopsy forceps, other polyp surgery histories will not be included in this study), history of gastroesophageal reflux (patients with self-reported acid reflux and heartburn symptoms and patients diagnosed by gastroscopy), and digestive tract obstruction; (7) Individuals with mental illnesses, communication difficulties, and inability to cooperate. (8) Patients who refuse to cooperate or choose to withdraw from the study due to personal reasons; (9) Those who need to change the surgical method due to surgical requirements; (10) Serious adverse events unrelated to the study drug that occur during the research process and cannot be included in the study or unexpected events; (11) Patients who are lost to follow-up due to various reasons; (12) Others.

研究实施时间：

Study execute time：

从 From 2025-05-20 00:00:00至 To 2026-05-15 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-05-20 00:00:00 至 To 2026-05-15 00:00:00  

干预措施：

Interventions：

组别：

Phase I:奥赛利定组（O组）

样本量：

30

Group：

Oliceridine Group

Sample size：

干预措施：

探索奥赛利定的ED95：试验设计奥赛利定初次给药剂量为30ug/kg静脉注射。同前，所有患者均先靶控输注丙泊酚，维持BIS值在40-60之间，直至手术结束。患者BIS降至60以下后给予奥赛利定30ug/kg静脉注射。所有患者手术前给予氟比洛芬酯50mg静脉注射，预防术后疼痛。改良警觉/镇静评分（MOAA/S）在0分或1分时开始手术。术中若出现镇痛不足（体动或SPI ＞ 50），追加10ug/kg奥赛利定。本次试验中，宫颈扩张或手术时出现体动都可视为药物剂量不足，认为是“失败”，否则就认为此次“成功”。如果该次失败，下一位患者则在该次诱导剂量的基础上增加一个剂量梯度。若此次成功，则下一位患者则在该次诱导剂量的基础上减少一个剂量梯度。剂量梯度为6ug/kg。

干预措施代码：

Intervention：

The initial dose of oliceridine administered intravenously is 30ug/kg. As before, all patients was given target-controlled infusion of propofol to maintain BIS values between 40-60 until the end of the surgery.After the BIS of the patient dropped below 60, intravenous injection of 30ug/kg of oliceridine was given. All patients were given intravenous injection of 50mg flurbiprofen axetil before surgery to prevent postoperative pain.When the MOAA/S was at 0 or 1 point,surgery began. If analgesia is ineffective during the operation(body moves or SPI>50), give the patient 10ug/kg of oliceridine. In this experiment, physical movement in response to cervical dilation and surgery was considered as ineffective analgesia (i.e. a "failure"),otherwise it will be considered as a "success". If the patient failed, the next patient received an additional incremental dose on top of the original induction dose; conversely, if the patient succeeded, the next patient received a reduction of one incremental dose. The interval dose was set at 6 μg/kg .

Intervention code：

组别：

Phase I:艾司氯胺酮组（E组）

样本量：

30

Group：

Esketamine Group

Sample size：

干预措施：

实验步骤同奥赛利定，根据既往研究及经验初步设定艾司氯胺酮组的初次剂量0.25mg/kg，梯度剂量为0.05 mg/kg，术中若镇痛不足则追加0.08mg/kg艾司氯胺酮。

干预措施代码：

Intervention：

The experimental procedure is the same as that of oliceridine. Based on previous research and experience, the initial dose of the Esketamine group is set at 0.25mg/kg,.The interval dose was set at 0.05 mg/kg.If analgesia is ineffective during the operation, give the patient 0. 08mg/kg of esketamine.

Intervention code：

组别：

Phase I: 舒芬太尼组（S组）

样本量：

30

Group：

Sufentanil Group

Sample size：

干预措施：

实验步骤同奥赛利定，根据既往研究及经验初步设定舒芬太尼组的初次剂量为0.15μg/kg，梯度剂量为0.03μg/kg，若术中镇痛不足则追加0.05μg/kg舒芬太尼。

干预措施代码：

Intervention：

The experimental procedure is the same as that of oliceridine. Based on previous research and experience, the initial dose of the Sufentanil group is set at 0.15μg/kg,.The interval dose was set at 0.03μg/kg.If analgesia is ineffective during the operation, give the patient0.05μg/kg of sufentanil .

Intervention code：

组别：

Phase II:奥赛利定组（O组）

样本量：

30

Group：

Oliceridine Group

Sample size：

干预措施：

手术开始前，所有患者靶控输注丙泊酚，维持BIS值在40-60之间，直至手术结束。当丙泊酚诱导后患者BIS降至60以下，给予一个ED95剂量的奥赛利定（注射时间30秒）；若术中出现镇痛不足，追加奥赛利定10ug/kg。所有患者手术前给予氟比洛芬酯50mg静脉注射。

干预措施代码：

Intervention：

Before the surgery , all patients was given target-controlled infusion of propofol to maintain BIS values between 40-60 until the end of the surgery. When the BIS drops below 60 after induction with propofol, the patients was given an ED95 dose of oliceridine (injection time 30 seconds); If analgesia is ineffective during the operation, give the patient 10ug/kg of oliceridine.All patients were given intravenous injection of 50mg flurbiprofen axetil before surgery.

Intervention code：

组别：

Phase II:艾司氯胺酮组（E组）

样本量：

30

Group：

Esketamine Group

Sample size：

干预措施：

手术开始前，所有患者靶控输注丙泊酚，维持BIS值在40-60之间，直至手术结束。当丙泊酚诱导后患者BIS降至60以下，给予一个ED95剂量的艾司氯胺酮和舒芬太（注射时间30秒）；若术中出现镇痛不足，追加艾司氯胺酮0.08mg/kg。所有患者手术前给予氟比洛芬酯50mg静脉注射。

干预措施代码：

Intervention：

Before the surgery , all patients was given target-controlled infusion of propofol to maintain BIS values between 40-60 until the end of the surgery. When the BIS drops below 60 after induction with propofol, patients was given an ED95 dose of esketamine (injection time 30 seconds); If analgesia is ineffective during the operation, give the patient 0. 08mg/kg of esketamine.All patients were given intravenous injection of 50mg flurbiprofen axetil before surgery.

Intervention code：

组别：

舒芬太尼组（S组）

样本量：

30

Group：

Sufentanil Group

Sample size：

干预措施：

手术开始前，所有患者靶控输注丙泊酚，维持BIS值在40-60之间，直至手术结束。当丙泊酚诱导后患者BIS降至60以下，给予一个ED95剂量的舒芬太尼（注射时间30秒）；若术中出现镇痛不足，追加舒芬太尼0.05ug/kg。所有患者手术前给予氟比洛芬酯50mg静脉注射。

干预措施代码：

Intervention：

Before the surgery , all patients was given target-controlled infusion of propofol to maintain BIS values between 40-60 until the end of the surgery. When the BIS drops below 60 after induction with propofol, the patients was given an ED95 dose of sufentanil (injection time 30 seconds); If analgesia is ineffective during the operation, give the patient 0.05ug/kg of sufentanil.All patients were given intravenous injection of 50mg flurbiprofen axetil before surgery.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 福建省 

市(区县)：

 厦门市 

Country：

China 

Province：

Fujian 

City：

Xiamen 

单位(医院)：

厦门大学附属第一医院 

单位级别：

三甲 

Institution
hospital：

The First Affiliated Hospital of Xiamen University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

呼吸抑制

指标类型：

主要指标

Outcome：

Respiratory depression

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

低氧血症

指标类型：

主要指标

Outcome：

Hypoxemia

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

平均动脉压

指标类型：

次要指标

Outcome：

mean arterial pressure

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

呼气末二氧化碳

指标类型：

次要指标

Outcome：

PetCO2

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

心率

指标类型：

次要指标

Outcome：

heart rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

呼吸频率

指标类型：

主要指标

Outcome：

Respiration Rate

Type：

Primary 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 64 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

根据患者手术先后时间，统计人员按照随机数字表法编码，获得随机数以后，用获取的随机数除以三余数为零的是O组（n=30），余数是一的是E组（n=30），为二的是S组（n=30）。

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

According to the patient's surgical sequence time, the statisticians encoded the random number using a random number table method. After obtaining the random number, the O group (n=30) obtained by dividing the obtained random number by three with a remainder of zero, the E group (n=30) with a remainder of one, and the S group (n=30) with a remainder of two.

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：

1.由不参与本试验麻醉实施、记录、随访的配药人员专职负责抽药，术前30min将术中诱导时的3种镇痛药物均用生理盐水配成5ml药液，术中追加的镇痛药物均用生理盐水配置成2ml药液。 2.主要麻醉者负责麻醉实施和随访（不知道具体镇痛给药情况和麻醉记录）； 3.另一麻醉师记录麻醉单（不参与麻醉实施和随访）。

Blinding：

1. The dedicated dispensing personnel who do not participate in the implementation, recording, and follow-up of anesthesia in this experiment are responsible for dispensing medication. 30 minutes before surgery, 5ml of the three types of analgesic drugs used during intraoperative induction are prepared with physiological saline, and 2ml of additional analgesic drugs used during surgery are prepared with physiological saline. 2. The main anesthesiologist is responsible for anesthesia implementation and follow-up (specific analgesic administration and anesthesia records are unknown); 3. Another anesthesiologist records the anesthesia sheet (not involved in anesthesia implementation and follow-up).

是否共享原始数据：

IPD sharing

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）：

无

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：

采用病例报告表收集数据，拟采用 epidata 软件和excel等建立数据库。

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

Data will be collected using case report forms, and a database will be established by Epidata software and Excel.

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：

  2025-05-19 09:45:40