简体中文|English
Trial search Nation, Province(City) Code of disease Primary sponsor(s) Secondary sponsor(s) Funding source Recruiting status Register status Measure Ethical committee Study type

Esketamine versus remifentanil as adjuvant to remimazolam for laryngeal mask anesthesia with spontaneous ventilation in hysteroscopy: a randomized trial

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注册号：

Registration number：

ChiCTR2600125823 

最近更新日期：

Date of Last Refreshed on：

2026-06-01 10:24:34 

注册时间：

Date of Registration：

2026-06-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

瑞马唑仑复合艾司氯胺酮与瑞芬太尼在保留自主呼吸宫腔镜手术中的比较

Public title：

Esketamine versus remifentanil as adjuvant to remimazolam for laryngeal mask anesthesia with spontaneous ventilation in hysteroscopy: a randomized trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

瑞马唑仑复合艾司氯胺酮与瑞芬太尼在保留自主呼吸宫腔镜手术中的比较

Scientific title：

Esketamine versus remifentanil as adjuvant to remimazolam for laryngeal mask anesthesia with spontaneous ventilation in hysteroscopy: a randomized 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：

张小龙 

研究负责人：

张小龙 

Applicant：

zhangxiaolong 

Study leader：

Xiaolong Zhang 

申请注册联系人电话：

Applicant telephone：

+86 136 8551 6500

研究负责人电话：

Study leader's telephone：

+86 136 8551 6500

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：

zhangxl1458@126.com

研究负责人电子邮件：

Study leader's E-mail：

zhangxl1458@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：

安徽省合肥市北二环1868号

研究负责人通讯地址：

No. 1868, North Second Ring Road, Hefei City, Anhui Province

Applicant address：

No. 1868, North Second Ring Road, Hefei City, Anhui Province

Study leader's address：

No. 1868, North Second Ring Road, Hefei City, Anhui 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：

安徽省第二人民医院

Applicant's institution：

Anhui No.2 Provincial People's Hospital

研究负责人所在单位：

安徽省第二人民医院

Affiliation of the Leader：

Anhui No.2 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：

(R) 2026-043

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：

安徽省第二人民医院医学研究伦理委员会

Name of the ethic committee：

Medical Research Ethics Committee of The Anhui No.2 Provincial People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2026-04-28 00:00:00

伦理委员会联系人：

李宇智

Contact Name of the ethic committee：

+86 13956990909

伦理委员会联系地址：

安徽省合肥市北二环1868号

Contact Address of the ethic committee：

No. 1868, North Second Ring Road, Hefei City, Anhui Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 139 5699 0909

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：

安徽省第二人民医院

Primary sponsor：

Anhui No.2 Provincial People's Hospital

研究实施负责（组长）单位地址：

安徽省合肥市北二环1868号

Primary sponsor's address：

No. 1868, North Second Ring Road, Hefei City, Anhui 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)：

安徽

市(区县)：

Country：

China

Province：

Anhui Pronvice

City：

单位(医院)：

安徽省第二人民医院

具体地址：

安徽省合肥市北二环1868号

Institution
hospital：

Anhui No.2 Provincial People's Hospital

Address：

No. 1868, North Second Ring Road, Hefei City, Anhui Province

经费或物资来源：

安徽省临床重点专科建设项目经费资助

Source(s) of funding：

Funding for the Key ClinicalSpecialty ConstructionProject of Anhui Province

Target disease：

Gynecological Uterine Disease

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：

在“喉罩全麻+术中全程保留自主呼吸”模式下，直接比较艾司氯胺酮与瑞芬太尼辅助瑞马唑仑的麻醉效果，重点评估两种方案的维持期呼吸抑制发生率，同时比较瑞马唑仑用量、苏醒时间、术后恢复质量、认知功能及不良事件发生率，为宫腔镜手术麻醉方案的选择提供高质量循证医学依据。  

Objectives of Study：

Under the mode of "laryngeal mask airway general anesthesia with spontaneous breathing maintained throughout the operation", this study directly compares the anesthetic effects of esketamine and remifentanil when combined with remimazolam. It focuses on evaluating the incidence of respiratory depression during the maintenance period of the two regimens, and also compares the dosage of remimazolam, recovery time, postoperative recovery quality, cognitive function and the incidence of adverse events, so as to provide high-quality evidence-based medical basis for the selection of anesthesia regimens in hysteroscopic surgery.

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. 性别：女性；年龄：18~60岁；体重指数（BMI）：18.5~28 kg/m²；美国麻醉医师协会（ASA）分级Ⅰ~Ⅱ级 2. 手术类型：择期行宫腔镜手术（包括宫腔镜检查、宫腔镜下息肉切除术、宫腔镜下肌瘤切除术等）； 3. 无手术及麻醉禁忌证； 4. 认知与配合能力：意识清晰，能够理解研究目的和流程，愿意配合完成术中监测及术后24 h随访

Inclusion criteria

,,( `≥` → `>=`,`≤` → `<=`,`m2` → `m^2`,`109` → `10^9`,`Ⅱ` → `II`),. `1.``2.``3.``4.`,: 1. Gender: Female; Age: 18~60 years old; Body Mass Index (BMI): 18.5~28 kg/m^2; American Society of Anesthesiologists (ASA) physical status classification: Grade I~II 2. Type of surgery: Elective hysteroscopic surgery (including hysteroscopy, hysteroscopic polypectomy, hysteroscopic myomectomy, etc.); 3. No contraindications to surgery and anesthesia; 4. Cognitive and compliance ability: Clear consciousness, able to understand the research purpose and procedures, and willing to cooperate with intraoperative monitoring and 24-hour postoperative follow-up.

排除标准：

1. 药物过敏：对艾司氯胺酮、瑞芬太尼、瑞马唑仑、咪达唑仑、舒芬太尼及其他研究相关麻醉药物过敏者； 2. 脏器功能障碍：存在严重心、肝、肾、肺等重要脏器功能障碍者； 3. 血压异常：存在未控制的高血压（收缩压≥160 mmHg或舒张压≥100 mmHg）者； 4. 呼吸相关疾病：患有睡眠呼吸暂停综合征（SAS）者； 5. 困难气道：Mallampati分级Ⅲ~Ⅳ级、张口度<3 cm、甲颏距离<6 cm者； 6. 艾司氯胺酮禁忌证：存在颅内压增高、青光眼、甲状腺功能亢进、精神疾病病史者； 7. 术前用药：术前24 h内使用过镇静、镇痛药物或酒精者； 8. 特殊人群：妊娠或哺乳期女性； 9. 其他：无法配合完成术后评估、随访，或拒绝签署知情同意书者。

Exclusion criteria：

1. Drug allergy: Those who are allergic to esketamine, remifentanil, remimazolam, midazolam, sufentanil and other research-related anesthetic drugs; 2. Organ dysfunction: Those with severe dysfunction of vital organs such as the heart, liver, kidney and lung; 3. Abnormal blood pressure: Those with uncontrolled hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg); 4. Respiratory diseases: Patients with sleep apnea syndrome (SAS); 5. Difficult airway: Those with Mallampati grade III~IV, mouth opening < 3 cm, thyromental distance < 6 cm; 6. Contraindications to esketamine: Those with increased intracranial pressure, glaucoma, hyperthyroidism, or a history of mental illness; 7. Preoperative medication: Those who have used sedatives, analgesics or alcohol within 24 hours before surgery; 8. Special populations: Pregnant or lactating women; 9. Others: Those who are unable to cooperate with postoperative evaluation and follow-up, or refuse to sign the informed consent form.

研究实施时间：

Study execute time：

从 From 2026-06-01 00:00:00至 To 2026-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-06-01 00:00:00 至 To 2026-08-31 00:00:00  

干预措施：

Interventions：

组别：

对照组（瑞芬太尼组）

样本量：

30

Group：

Control Group (Remifentanil Group)

Sample size：

干预措施：

患者进入手术间后，由麻醉医生依次静脉推注咪达唑仑0.05 mg/kg（推注速度2 mg/min）、舒芬太尼0.15 μg/kg（推注速度0.5 μg/kg/min）、瑞马唑仑0.3 mg/kg（推注速度0.1 mg/kg/min）。待研究对象意识消失（呼唤无应答）、下颌松弛后，于给药后约90 s置入合适型号喉罩：体重<60 kg选用3号喉罩，体重≥60 kg选用4号喉罩，置入过程全程保留自主呼吸，密切监测SpO?和RR，记录诱导期是否出现呼吸抑制（仅作为安全性指标，不计入主要结局）。 3. 麻醉维持：术中持续泵注瑞马唑仑，初始输注速率为1.0 mg·kg?1·h?1，术中根据BIS值调整速率，目标BIS值为50~70（BIS<50时减慢输注速率，BIS>70时加快输注速率）。持续泵注瑞芬太尼，输注速率为0.075 μg·kg?1·min?1（该剂量基于预试验确定，可满足手术镇痛需求且安全性可控）。

干预措施代码：

Intervention：

After the patient enters the operating room, the anesthesiologist sequentially administers intravenous injections of midazolam 0.05 mg/kg (injection rate: 2 mg/min), sufentanil 0.15 μg/kg (injection rate: 0.5 μg/kg/min), and remimazolam 0.3 mg/kg (injection rate: 0.1 mg/kg/min). Once the subjects lose consciousness (no response to verbal calling) and develop jaw relaxation, a properly sized laryngeal mask airway (LMA) is inserted approximately 90 seconds after medication administration: size 3 LMA for patients with body weight < 60 kg and size 4 LMA for those with body weight ≥ 60 kg. Spontaneous breathing is maintained throughout the insertion process. SpO? and respiratory rate (RR) are closely monitored, and the occurrence of respiratory depression during the induction period is recorded (only used as a safety indicator and not included in the primary outcomes). Anesthesia Maintenance: Remimazolam is continuously infused intraoperatively at an initial rate of 1.0 mg·kg?1·h?1. The infusion rate is adjusted intraoperatively according to the BIS value, with a target BIS range of 50 to 70 (reduce the infusion rate when BIS < 50, and increase it when BIS > 70). Remifentanil is continuously infused at a rate of 0.075 μg·kg?1·min?1 (this dosage is determined based on preliminary trials, which can meet intraoperative analgesic requirements with controllable safety). Note: Midazolam, sufentanil, remimazolam and remifentanil are nationally controlled drugs with potential addiction risks, which must be used under the guidance of professional physicians.

Intervention code：

组别：

试验组 （艾斯氯胺酮组）

样本量：

30

Group：

Experimental Group (Esketamine Group)

Sample size：

干预措施：

患者入手术间后，由麻醉医生依次静脉推注咪达唑仑0.05 mg/kg（推注速度2 mg/min）、舒芬太尼0.15 μg/kg（推注速度0.5 μg/kg/min）、瑞马唑仑0.3 mg/kg（推注速度0.1 mg/kg/min）。待研究对象意识消失（呼唤无应答）、下颌松弛后，于给药后约90 s置入合适型号喉罩：体重<60 kg选用3号喉罩，体重≥60 kg选用4号喉罩，置入过程全程保留自主呼吸，密切监测SpO?和RR，记录诱导期是否出现呼吸抑制（仅作为安全性指标，不计入主要结局）。 3. 麻醉维持：两组镇静方案完全一致，持续泵注瑞马唑仑，初始输注速率为1.0 mg·kg?1·h?1，术中根据BIS值调整速率，目标BIS值为50~70（BIS<50时减慢输注速率，BIS>70时加快输注速率）。术中持续泵注艾司氯胺酮，输注速率为0.15 mg·kg?1·h?1（该剂量基于预试验确定，可满足手术镇痛需求且安全性可控）。

干预措施代码：

Intervention：

After the patient enters the operating room, the anesthesiologist intravenously injects midazolam at a dose of 0.05 mg/kg (injection rate: 2 mg/min), sufentanil at 0.15 μg/kg (injection rate: 0.5 μg/kg/min), and remimazolam at 0.3 mg/kg (injection rate: 0.1 mg/kg/min) in sequence. Once the subjects lose consciousness (no response to verbal calling) and achieve mandibular relaxation, a laryngeal mask airway of appropriate size is inserted approximately 90 seconds after medication administration: size 3 for patients weighing less than 60 kg and size 4 for those weighing 60 kg or above. Spontaneous breathing is maintained throughout the insertion process, with continuous close monitoring of SpO? and RR. The occurrence of respiratory depression during the induction period is recorded (used only as a safety indicator and not included in the primary outcomes). Anesthesia Maintenance: The sedation regimens of the two groups are completely identical. Remimazolam is continuously pumped and infused with an initial infusion rate of 1.0 mg·kg?1·h?1, which is adjusted intraoperatively according to BIS values, with a target BIS range of 50 to 70 (reduce the infusion rate when BIS < 50 and increase it when BIS > 70). Esketamine is continuously infused during surgery at a rate of 0.15 mg·kg?1·h?1 (this dosage is determined based on preliminary trials, which can meet surgical analgesic needs with controllable safety).

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 安徽省 

市(区县)：

  

Country：

China 

Province：

Anhui Province 

City：

 

单位(医院)：

安徽省第二人民医院 

单位级别：

三甲 

Institution
hospital：

Anhui No.2 Provincial People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

维持期呼吸抑制发生率

指标类型：

主要指标

Outcome：

Incidence of respiratory depression during maintenance period

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

PACU 停留时间

指标类型：

次要指标

Outcome：

PACU stay 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：

术后 2–24 h 恶心呕吐（PONV）发生率

指标类型：

次要指标

Outcome：

Incidence of postoperative nausea and vomiting (PONV) within 2–24 hours after surgery

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

停药至拔喉罩时间

指标类型：

次要指标

Outcome：

Time from drug discontinuation to laryngeal mask removal

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后 24 小时 QoR-15 评分

指标类型：

次要指标

Outcome：

24-hour postoperative QoR-15 score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术中显著体动发生率

指标类型：

次要指标

Outcome：

Incidence of significant intraoperative body movement

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

瑞马唑仑单位时间用量

指标类型：

次要指标

Outcome：

Dosage of Remimazolam per unit time

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）：

由未参与临床麻醉、结局评估及数据统计的统计人员，采用计算机生成随机数字表，按1:1比例将符合纳入标准的研究对象随机分配至艾司氯胺酮组（E组）和瑞芬太尼组（R组）。

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

Statisticians who were not involved in clinical anesthesia, outcome evaluation and data statistics adopted a computer-generated random number table to randomly assign the eligible subjects at a 1:1 ratio to the esketamine group (Group E) and the remifentanil group (Group R).

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：

所有研究药物（艾司氯胺酮、瑞芬太尼、瑞马唑仑等）均为无色透明液体，实现外观盲法。诱导期药物由研究护士按预设剂量混合于同一注射器，标注“诱导液”后交由麻醉医生使用；维持期使用两个外观完全相同的输注泵，分别标注“镇静泵”（瑞马唑仑）和“镇痛泵”（艾司氯胺酮或瑞芬太尼），由研究护士按分组配置后连接至研究对象静脉通路，麻醉医生仅负责根据脑电双频指数（BIS）调整镇静泵输注速率，不参与药物配置。 患者、手术医师、术后评估者及统计分析师对分组情况设盲，麻醉医生因需根据血流动力学变化调整麻醉方案，故不设盲

Blinding：

All study medications (esketamine, remifentanil, remimazolam, etc.) were colorless and transparent liquids to achieve appearance blinding. During the induction period, the study nurses mixed the drugs at preset doses into the same syringe, labeled it as "induction solution", and then handed it over to anesthesiologists for use. For the maintenance period, two infusion pumps with identical appearance were used, labeled as "sedation pump" (remimazolam) and "analgesia pump" (esketamine or remifentanil) respectively. The research nurses prepared the medications according to the grouping and connected the pumps to the subjects' venous access. Anesthesiologists were only responsible for adjusting the infusion rate of the sedation pump based on the Bispectral Index (BIS) and did not participate in drug preparation. Patients, surgeons, postoperative evaluators, and statistical analysts are blinded to group assignments. Anesthesiologists are not blinded because they need to adjust the anesthesia plan according to hemodynamic changes.

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

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)：

No

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

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

CRF

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：

  2026-06-01 10:24:20
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