ChiCTR2600123888 版本V1.0 版本创建时间2026/04/30 15:58:33 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：

 ChiCTR2600123888 

最近更新日期：

Date of Last Refreshed on：

 2026-04-30 15:58:27 

注册时间：

Date of Registration：

 2026-04-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

环泊酚在无痛取卵术中的有效性与安全性研究

Public title：

A Study on the Efficacy and Safety of Ciprofol in Painless Oocyte Retrieval

注册题目简写：

English Acronym：

研究课题的正式科学名称：

环泊酚在无痛取卵术中的有效性与安全性研究

Scientific title：

A Study on the Efficacy and Safety of Ciprofol in Painless Oocyte Retrieval

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：

王明朕 

研究负责人：

董瑞 

Applicant：

Mingzhen Wang 

Study leader：

Rui Dong 

申请注册联系人电话：

Applicant telephone：

 +86 532 8271 6868

研究负责人电话：

Study leader's
telephone：

+86 532 8271 6868

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：

 17861202570@163.com

研究负责人电子邮件：

Study leader's E-mail：

 dongrui@whu.edu.cn

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：

山东省青岛市市南区东海中路5号

研究负责人通讯地址：

山东省青岛市市南区东海中路5号

Applicant address：

No. 5, Donghai Middle Road, Shinan District, Qingdao City, Shandong Province

Study leader's address：

No. 5, Donghai Middle Road, Shinan District, Qingdao City, Shandong 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：

青岛市市立医院

Applicant's institution：

Qingdao Municipal Hospital

研究负责人所在单位：

青岛市市立医院

Affiliation of the Leader：

Qingdao Municipal 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：

 2025-KY-032

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：

青岛市市立医院医学伦理委员会

Name of the ethic committee：

Clinical Trial Ethics Committee of Qingdao Municipal Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-07-09 00:00:00

伦理委员会联系人：

代旭东

Contact Name of the ethic committee：

Xudong Dai

伦理委员会联系地址：

青岛市市北区胶州路1号

Contact Address of the ethic committee：

No. 1 Jiaozhou Road, Shibei District, Qingdao City

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 532 8890 5831

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：

青岛市市立医院

Primary sponsor：

Qingdao Municipal Hospital

研究实施负责（组长）单位地址：

山东省青岛市市南区东海中路5号

Primary sponsor's address：

No. 5, Donghai Middle Road, Shinan District, Qingdao City, Shandong 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)：

山东省

市(区县)：

青岛市

Country：

China

Province：

Shandong

City：

Qingdao

单位(医院)：

青岛市市立医院

具体地址：

山东省青岛市市南区东海中路5号

Institution
hospital：

Qingdao Municipal Hospital

Address：

No. 5, Donghai Middle Road, Shinan District, Qingdao City, Shandong Province

经费或物资来源：

山东省自然科学基金

Source(s) of funding：

Natural Science Foundation of Shandong Province (ZR2024QH247)

研究疾病：

不孕症  

Target disease：

Infertility

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

连续入组 

Study design：

Sequential 

研究目的：

本项目拟通过研究环泊酚与丙泊酚在卵泡液中的分布特征及代谢动力学差异，评估两种药物对胚胎发育潜能及远期妊娠结局的影响, 旨在构建静脉麻醉药物生殖安全性的综合评价体系，为临床用药提供剂量优化方案。  

Objectives of Study：

This project aims to investigate the distribution characteristics and metabolic kinetics differences of etomidate and propofol in follicular fluid, and to evaluate the effects of these two drugs on embryonic developmental potential and long-term pregnancy outcomes. The goal is to establish a comprehensive evaluation system for the reproductive safety of intravenous anesthetic drugs, and to provide dose optimization plans for clinical use.

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. 符合无痛取卵术适应证，且患者均能耐受： 2.ASA(美国麻醉医师协会病人状态分级) I-II级，患者年龄在20-45岁，体重指数18.5—27.9kg/m^2； 3. 意识清楚，能与医生进行沟通、交流。能在医师指导下理解视觉模拟评分法； 4. 既往无高血压、冠心病等心血管疾病史病史； 5.无神经精神系统疾患； 6.无严重药物过敏史； 7.术前肝肾功能正常； 8.无严重血液系统疾病； 9. 近期无上呼吸道感染； 10.无酒精成瘾，无脂肪代谢紊乱症。

Inclusion criteria

1. The patient meets the indications for painless egg retrieval and can tolerate the procedure: 2. ASA (American Society of Anesthesiologists patient condition classification) level I-II, the patient's age is between 20 and 45 years old, and the body mass index is 18.5 - 27.9 kg/m^2; 3. The patient has clear consciousness and can communicate and interact with the doctor. They can understand the visual analog scale method under the guidance of the doctor; 4. There is no history of cardiovascular diseases such as hypertension and coronary heart disease in the past; 5. No neurological or mental disorders; 6. No severe drug allergy history; 7. Preoperative liver and kidney functions are normal; 8. No serious blood system diseases; 9. No recent upper respiratory tract infection; 10. No alcohol addiction, no fat metabolism disorder.

排除标准：

1.长期应用麻醉性镇痛药、镇静剂或非甾体类抗炎药物史者； 2.合并空卵泡综合征、外阴具有湿疹等皮肤疾病者； 3.多囊卵巢综合征患者； 4.有牛奶鸡蛋过敏及其他特殊病史者： 5.有明确影响胚胎着床的其他因素:子宫畸形、输卵管积水、宫腔粘连、子宫内膜息肉、粘膜下肌瘤或明显压迫子宫内膜的子宫肌瘤等: 6.有腹腔镜和/或超声检查证据的子宫内膜异位症、卵巢巧克力囊肿或卵巢囊肿直径>3cm者; 7.男女双方存在明显自身免疫性或内分泌疾病疾病； 8.生殖系统结核患者； 9.女性患者取卵日取消取卵。

Exclusion criteria：

1. Those with a history of long-term use of narcotic analgesics, sedatives or non-steroidal anti-inflammatory drugs; 2. Those with polycystic ovary syndrome, or external genitalia with eczema or other skin diseases; 3. Patients with polycystic ovary syndrome; 4. Those with milk or egg allergies and other special medical histories; 5. Those with other factors that clearly affect embryo implantation: uterine malformations, pelvic effusion, intrauterine adhesions, endometrial polyps, submucosal fibroids or uterine fibroids that significantly compress the endometrium, etc.; 6. Those with endometriosis, ovarian chocolate cysts or ovarian cysts larger than 3 cm, with evidence of laparoscopy and/or ultrasound examination; 7. Both male and female patients have obvious autoimmune or endocrine diseases; 8. Patients with reproductive system tuberculosis; 9. Female patients whose egg retrieval was cancelled on the day of retrieval.

研究实施时间：

Study execute time：

从 From 2026-04-30 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-04-30 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

环泊酚组

样本量：

 319

Group：

Ciprofol Group

Sample size：

干预措施：

患者步入手术室后由护士协助患者取膀胱截石位，手术医师、麻醉医师及手术室护士对患者身份行三方核查。由麻醉医师给患者行鼻导管吸氧4 L/min，提高氧储备，监测血压、心率、SpO2。护士采用 22G 留置针开放上肢静脉,手术医师铺巾、并进行物品准备。 手术医生、麻醉医师准备就绪，待静脉通道建立完成后先静推环泊酚0.4mg/kg，待患者睫毛反射消失后，再静注布托啡诺(10μg/kg)，诱导用时30-50s，诱导完成后将其头取侧位，通畅呼吸道，MOAA/S镇静评分＜1时开始手术。 术中患者如出现体动或睁眼追加用药(若仅剩1~2枚优势卵泡未穿刺，患者出现 1~2级体动，且无困难穿刺状态，不追加用药)，每次追加环泊酚0.2mg/kg至体动消失或入睡，术毕未使用术后镇痛药。术中平均动脉压<60mmHg，若>3min 未恢复预期，则麻黄碱 6mg静推。心率<50次/分，则阿托品0.4 mg静推。SpO2<95%，>5秒，上提下颌; SpO2<90%，>5秒，则手控呼吸。 取卵术在超声引导下经阴道进行，采用17G穿刺针，经阴道穹窿进针，连接负压吸引装置，压力设定 150KPa，逐个抽吸双侧卵巢内大于1.2cm 以上的卵泡，直至全部抽吸完毕。手术结束后，转运至PACU。

干预措施代码：

Intervention：

Upon entering the operating room, the patient was assisted into the lithotomy position by nursing staff, followed by a three-part identity verification by the surgical team, anesthesiologist, and operating room nurse. The anesthesiologist administered nasal oxygen at 4 L/min to enhance oxygen reserve while continuously monitoring blood pressure, heart rate, and SpO?. A nurse established intravenous access using a 22-gauge indwelling needle in an upper limb vein, while the surgeon prepared the sterile field and instruments. After confirming readiness of both surgical and anesthesia teams and securing intravenous access, anesthesia induction was initiated with an intravenous bolus of Ciprofol (0.4 mg/kg). Upon disappearance of the eyelash reflex, Butorphanol (10 μg/kg) was administered intravenously, completing induction within 30-50 seconds. The patient's head was then turned laterally to maintain airway patency, and the procedure commenced when the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score dropped below 1. During the procedure, body movement or eye opening triggered supplemental boluses of Ciprofol 0.2 mg/kg until cessation of movement or resedation, except when only one or two dominant follicles remained unaspirated with Grade 1-2 movement and no technical difficulty. No postoperative analgesics were administered. For hypotension (MAP <60 mmHg lasting >3 minutes), 6 mg Ephedrine was administered intravenously. Bradycardia (HR <50 bpm) was treated with 0.4 mg Atropine IV. Oxygen desaturation (SpO? <95% for >5 seconds) prompted jaw thrust maneuver, while SpO? <90% for >5 seconds required manual ventilation. The oocyte retrieval was performed under transvaginal ultrasound guidance using a 17-gauge needle inserted through the vaginal fornix, connected to negative pressure suction set at 150 kPa. All follicles exceeding 1.2 cm in diameter were aspirated from both ovaries until complete evacuation. Upon completion, the patient was transferred to the Post-Anesthesia Care Unit (PACU).

Intervention code：

组别：

丙泊酚组

样本量：

 319

Group：

Propofol Group

Sample size：

干预措施：

患者步入手术室后由护士协助患者取膀胱截石位，手术医师、麻醉医师及手术室护士对患者身份行三方核查。由麻醉医师给患者行鼻导管吸氧4 L/min，提高氧储备，监测血压、心率、SpO2。护士采用 22G 留置针开放上肢静脉,手术医师铺巾、并进行物品准备。 手术医生、麻醉医师准备就绪，待静脉通道建立完成后先静推丙泊酚2.0mg/kg，待患者睫毛反射消失后，再静注布托啡诺(10μg/kg)，诱导用时30-50s，诱导完成后将其头取侧位，通畅呼吸道，MOAA/S镇静评分＜1时开始手术。 术中患者如出现体动或睁眼追加用药(若仅剩1~2枚优势卵泡未穿刺，患者出现 1~2级体动，且无困难穿刺状态，不追加用药)，每次追加丙泊酚：1.0mg/kg至体动消失或入睡，术毕未使用术后镇痛药。术中平均动脉压<60mmHg，若>3min 未恢复预期，则麻黄碱 6mg静推。心率<50次/分，则阿托品0.4 mg静推。SpO2<95%，>5秒，上提下颌; SpO2<90%，>5秒，则手控呼吸。 取卵术在超声引导下经阴道进行，采用17G穿刺针，经阴道穹窿进针，连接负压吸引装置，压力设定 150KPa，逐个抽吸双侧卵巢内大于1.2cm 以上的卵泡，直至全部抽吸完毕。手术结束后，转运至PACU。

干预措施代码：

Intervention：

After entering the operating room, the patient was assisted into the lithotomy position by nursing staff, followed by a three-part verification of patient identity by the surgical team, anesthesiologist, and operating room nurse. The anesthesiologist administered nasal oxygen at 4 L/min to enhance oxygen reserve while continuously monitoring blood pressure, heart rate, and SpO?. A nurse established intravenous access using a 22-gauge indwelling needle in an upper limb vein, while the surgeon prepared the sterile field and instruments. Upon confirmation of readiness from both surgical and anesthesia teams and after securing intravenous access, anesthesia induction commenced with an intravenous bolus of Propofol (2.0 mg/kg). Following disappearance of the eyelash reflex, Butorphanol (10 μg/kg) was administered intravenously, taking 30-50 seconds for induction. The patient's head was then turned laterally to maintain airway patency, and the procedure began when the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score fell below 1. During surgery, body movement or eye opening prompted supplemental Propofol boluses (1.0 mg/kg) until movement ceased or the patient returned to sleep, except when only one or two dominant follicles remained unaspirated with Grade 1-2 movement and no technical difficulty. No postoperative analgesics were administered. For hypotension (MAP <60 mmHg persisting >3 minutes), 6 mg Ephedrine was administered intravenously; bradycardia (HR <50 bpm) was treated with 0.4 mg Atropine IV. Oxygen desaturation (SpO? <95% for >5 seconds) was managed with jaw thrust maneuver, while SpO? <90% for >5 seconds required manual ventilation. The oocyte retrieval proceeded under transvaginal ultrasound guidance using a 17-gauge needle inserted through the vaginal fornix, connected to negative pressure suction set at 150 kPa. All follicles exceeding 1.2 cm in diameter were aspirated sequentially from both ovaries until complete evacuation. Upon procedure completion, the patient was transferred to the Post-Anesthesia Care Unit (PACU).

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东 

市(区县)：

 青岛 

Country：

China

Province：

Shandong

City：

Qingdao

单位(医院)：

 青岛市市立医院 

单位级别：

 三甲 

Institution
hospital：

Qingdao Municipal Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

体动发生率

指标类型：

主要指标

Outcome：

Incidence of involuntary body movements

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不同取卵次序下卵泡液中环泊酚的药物浓度

指标类型：

次要指标

Outcome：

Drug concentrations of Ciprofol in follicular fluid across different follicle aspiration sequences

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不同取卵次序下卵泡液中丙泊酚的药物浓度

指标类型：

次要指标

Outcome：

Drug concentrations of Propofol in follicular fluid across different follicle aspiration sequences

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不同取卵次序下卵泡液中布托啡诺的药物浓度

指标类型：

次要指标

Outcome：

Drug concentrations of Butorphanol in follicular fluid across different follicle aspiration sequences

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不同取卵次序下卵泡液的IL-6水平

指标类型：

次要指标

Outcome：

IL-6 levels in follicular fluid across aspiration sequences

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不同取卵次序下卵泡液的ROS水平

指标类型：

次要指标

Outcome：

Reactive oxygen species (ROS) levels in follicular fluid by aspiration sequence

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

胚胎质量指标

指标类型：

次要指标

Outcome：

Embryo quality parameters

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

妊娠结局指标

指标类型：

次要指标

Outcome：

Pregnancy outcome measures

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术中生命体征

指标类型：

次要指标

Outcome：

Intraoperative vital signs

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

患者舒适度指标

指标类型：

次要指标

Outcome：

Patient comfort parameters

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：

卵泡液

组织：

Sample Name：

Follicular Fluid

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 20 岁 years
最大 Max age 45 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）：

无

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

None

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：

无

Blinding：

None

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）：

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：

CRF;EDC

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

CRF;EDC

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：

  2026-04-30 15:58:27