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等效剂量环泊酚和丙泊酚在老年患者胃镜检查中有效性和安全性的比较
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注册号：

Registration number：

 ChiCTR2600117482 

最近更新日期：

Date of Last Refreshed on：

 2026-01-26 08:21:30 

注册时间：

Date of Registration：

 2026-01-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

等效剂量环泊酚和丙泊酚在老年患者胃镜检查中有效性和安全性的比较

Public title：

Comparison of the efficacy and safety of equivalent doses of ciprofol versus propofol in elderly patients undergoing gastroscopy.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

等效剂量环泊酚和丙泊酚在老年患者胃镜检查中有效性和安全性的比较

Scientific title：

Comparison of the efficacy and safety of equivalent doses of ciprofol versus propofol in elderly patients undergoing gastroscopy.

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：

刘子赫 

研究负责人：

李松泽,刘子赫 

Applicant：

Liu Zihe 

Study leader：

LI Songze,Liu Zihe 

申请注册联系人电话：

Applicant telephone：

 +86 180 4139 9715

研究负责人电话：

Study leader's
telephone：

+86 180 4139 4511

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：

 15511549197@163.com

研究负责人电子邮件：

Study leader's E-mail：

 lisongze999@163.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：

辽宁省沈阳市大东区小河沿路44号

研究负责人通讯地址：

辽宁省沈阳市大东区小河沿路44号

Applicant address：

No.44 Xiaoheyan Road, Dadong District, Shenyang 110042, Liaoning Province, P R China

Study leader's address：

No.44 Xiaoheyan Road, Dadong District, Shenyang 110042, Liaoning Province, P R China

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：

辽宁省肿瘤医院

Applicant's institution：

Liaoning Cancer Hospital & Institute 

研究负责人所在单位：

辽宁省肿瘤医院

Affiliation of the Leader：

Liaoning Cancer Hospital & Institute 

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：

 KY20251206

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：

辽宁肿瘤医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Liaoning Cancer Hospital & Institute

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-12-03 00:00:00

伦理委员会联系人：

丁欣

Contact Name of the ethic committee：

Ding Xin

伦理委员会联系地址：

辽宁省沈阳市大东区小河沿路44号

Contact Address of the ethic committee：

44 Xiaoheyan Road,Dadong District,Shenyang,Liaoning

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 186 4401 5667

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：

辽宁省肿瘤医院

Primary sponsor：

Liaoning Cancer Hospital & Institute

研究实施负责（组长）单位地址：

辽宁省沈阳市大东区小河沿路44号

Primary sponsor's address：

Liaoning Cancer Hospital & Institute No.44 Xiaoheyan Road, Dadong District, Shenyang 110042, Liaoning Province, P R China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

辽宁省

市(区县)：

Country：

China

Province：

Liaoning Province

City：

单位(医院)：

辽宁省肿瘤医院

具体地址：

辽宁省沈阳市大东区小河沿路44号

Institution
hospital：

Liaoning Cancer Hospital

Address：

44 Xiaoheyan Road,Dadong District,Shenyang,Liaoning

经费或物资来源：

辽宁省科技厅应用基础研究计划

Source(s) of funding：

Liaoning Provincial Basic Research Program - Applied Research Direction

研究疾病：

消化内镜检查中的老年患者麻醉/镇静管理研究  

Target disease：

Anesthesia/Sedation Management in Geriatric Patients Undergoing Gastrointestinal Endoscopy

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：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究的目的是比较等效剂量的环泊酚与丙泊酚联合阿芬太尼应用于老年患者胃镜检查的有效性和安全性，为临床合理应用环泊酚与丙泊酚提供参考。  

Objectives of Study：

The aim of this study is to compare the efficacy and safety of ciprofol versus propofol at equivalent doses, both combined with alfentanil, for gastroscopy in elderly patients, thereby providing a reference for the rational clinical use of ciprofol and propofol.

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.已知对所使用的麻醉药物如环泊酚、阿片类药物及其他药品、蛋制品或大豆过敏或禁忌; 2.患有神经系统疾病(颅脑损伤、可能存在惊厥、肌阵挛、颅内高压、脑动脉瘤、脑血管意外病史者;精神分裂症、躁狂症、精神错乱、长期服用精神类药物、意识障碍病史、认知功能障碍病史等)或1周内服用过阿片类药物或镇静剂; 3.有酗酒史（筛选期前3个月内有过度饮酒,即每天摄入酒精量达到两个单位以上，1单位=360mL啤酒或45mL酒精量为40%的白酒或150mL葡萄酒)或阿片类药物或镇静催眠药物成瘾史; 4.孕妇和哺乳期妇女; 5.预计存在困难气道或需气管插管(包括喉罩); (a)哮喘史、喘鸣; (b)睡眠呼吸暂停综合征者; (c)有恶性高热病史或家族史; (d)有气管插管失败经历者; (e)筛选时经研究者判断存在困难气道或被判定为气管插管操作有困难(改良马氏评分为IV级); 6.具有全麻禁忌证或者既往出现过麻醉意外史; 7.既往有肝肾功能不全病史，合并严重的心脏疾病、呼吸系统疾病; (a)心血管病史:调节前的高血压[没有使用专业降压药)高压(SBP)>=170mmHg和/或低压(DBP)>=105mmHg,或高血压药物治疗后SBP>160mmHg和/或DBP>100mmHg]、严重心脏疾病、心功能不全、阿-斯综合征、不稳定心绞痛、筛选前近6个月内发生心肌梗塞、需药物治疗的心动过速/过缓史、三度房室传导阻滞或QTcF间期>=450ms(按Fridericia’s公式校正); (b)呼吸系统病史:呼吸功能不全、吸入性肺部疾病史、筛选前3个月内出现需治疗的支气管痉挛史、基线期前1周内患上急性呼吸系统炎症,且有明显的高烧、呼吸不畅、咳嗽咳痰等呼吸系统症状者; 8.有常规内镜操作的禁忌者;

Exclusion criteria：

1.Known allergy or contraindication to anesthetic drugs (e.g., ciprofol, opioids), egg products, soy, or related pharmaceuticals; 2.Neurological disorders (including: traumatic brain injury, seizure disorders, myoclonus, intracranial hypertension, cerebral aneurysm, cerebrovascular accident; schizophrenia, mania, psychosis, chronic psychotropic medication use, impaired consciousness, cognitive dysfunction) OR opioid/sedative use within 1 week; 3.History of alcohol abuse (>2 standard drinks/day in past 3 months; 1 drink=14g alcohol: 360mL beer/45mL 40% spirits/150mL wine) OR substance use disorder (opioids/sedative-hypnotics); 4.Pregnant or lactating women; 5.Anticipated difficult airway or need for intubation (including laryngeal mask): (a) Asthma/wheezing history (b) Sleep apnea syndrome (c) Personal/family history of malignant hyperthermia (d) Previous failed intubation (e) Clinically assessed difficult airway (Modified Mallampati Score IV); 6.General anesthesia contraindications or prior anesthesia accidents; 7.Significant organ dysfunction/comorbidities: (a) Cardiovascular: Uncontrolled hypertension (SBP>=170mmHg or DBP>=105mmHg untreated; >160/>100mmHg on treatment), severe cardiac disease, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction (<=6 months), medication-requiring bradycardia/tachycardia, third-degree AV block, QTcF>=450ms (b) Respiratory: Respiratory insufficiency, aspiration pneumonitis, bronchospasm requiring treatment (<=3 months), active respiratory infection with fever/dyspnea/cough (<=1 week); 8.Contraindications to routine endoscopy;

研究实施时间：

Study execute time：

从 From 2026-01-30 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-01-30 00:00:00 至 To 2026-06-30 00:00:00

干预措施：

Interventions：

组别：

环泊酚序贯组C1

样本量：

 30

Group：

Ciprofol Sequential Design Group

Sample size：

干预措施：

基于预实验的研究和相关文献,确定C1组环泊酚的初始剂量为0.3mg/kg,剂量梯度为0.02mg/kg。首先确定正式试验的第一例患者:首次出现阴性和阳性反应改变的前一例患者,并由此开始进行试验,根据前一例患者的反应来确定下一例患者环泊酚的剂量。如胃镜置入反应阳性,则下一例患者剂量增加0.02mg/kg;反之,则减少一个剂量梯度,重复此过程直至观察到第8个交叉拐点时终止试验。

干预措施代码：

Intervention：

Based on preliminary experiments and relevant literature, the initial dose of ciprofol in Group C1 was set at 0.3 mg/kg, with a dose gradient of 0.02 mg/kg. The formal trial commenced with the patient immediately preceding the first negative-to-positive response transition. Starting from this patient, the dose of ciprofol for each subsequent patient was determined by the response of the preceding patient: if gastroscope insertion elicited a positive response, the dose was increased by 0.02 mg/kg for the next patient; conversely, it was decreased by one dose gradient. This process was repeated until the eighth crossover inflection point was observed, at which point the trial was terminated.

Intervention code：

组别：

丙泊酚序贯组P1

样本量：

 30

Group：

Propofol Sequential Design Group

Sample size：

干预措施：

基于预实验的研究和相关文献,确定P1组丙泊酚的初始剂量为1.5mg/kg,剂量梯度为0.1mg/kg。首先确定正式试验的第一例患者:首次出现阴性和阳性反应改变的前一例患者,并由此开始进行试验,根据前一例患者的反应来确定下一例患者丙泊酚的剂量。如胃镜置入反应阳性,则下一例患者剂量增加0.1mg/kg;反之,则减少一个剂量梯度,重复此过程直至观察到第8个交叉拐点时终止试验。

干预措施代码：

Intervention：

Based on preliminary experiments and relevant literature, the initial dose of propofol in Group P1 was set at 1.5 mg/kg, with a dose gradient of 0.1 mg/kg. The formal trial commenced with the patient immediately preceding the first negative-to-positive response transition. Starting from this patient, the dose of propofol for each subsequent patient was determined by the response of the preceding patient: if gastroscope insertion elicited a positive response, the dose was increased by 0.1 mg/kg for the next patient; conversely, it was decreased by one dose gradient. This process was repeated until the eighth crossover inflection point was observed, at which point the trial was terminated.

Intervention code：

组别：

环泊酚组C2

样本量：

 60

Group：

The Ciprofol Group

Sample size：

干预措施：

经鼻插管氧合后60s内静脉注射7μg/kg阿芬太尼(时间不短于30s)后，C2组给予有效剂量环泊酚。两组的剂量是根据第一步和初步结果计算的每种麻醉剂的 ED95的95%置信区间内的最大值确定的。

干预措施代码：

Intervention：

Following nasopharyngeal oxygen insufflation, alfentanil (7 μg/kg) was administered intravenously over a period of at least 30 seconds, but within 60 seconds. Subsequently, patients in Group C2 received an effective dose of ciprofol. For both groups, the respective drug dose was determined as the upper limit of the 95% confidence interval for the ED95 of each agent, calculated based on the results of the first phase (sequential trial) and preliminary data.

Intervention code：

组别：

丙泊酚组P2

样本量：

 60

Group：

The Propofol Group

Sample size：

干预措施：

经鼻插管氧合后60s内静脉注射7μg/kg阿芬太尼(时间不短于30s)后，C2组给予有效剂量丙泊酚。两组的剂量是根据第一步和初步结果计算的每种麻醉剂的 ED95的95%置信区间内的最大值确定的。

干预措施代码：

Intervention：

Following nasopharyngeal oxygen insufflation, alfentanil (7 μg/kg) was administered intravenously over a period of at least 30 seconds, but within 60 seconds. Subsequently, patients in Group P2 received an effective dose of propofol. For both groups, the respective drug dose was determined as the upper limit of the 95% confidence interval for the ED95 of each agent, calculated based on the results of the first phase (sequential trial) and preliminary data.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 辽宁省 

市(区县)：

  

Country：

China

Province：

Liaoning Province

City：

单位(医院)：

 辽宁省肿瘤医院 

单位级别：

 三甲 

Institution
hospital：

Liaoning Cancer Hospital & Institute

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

平均动脉压

指标类型：

主要指标

Outcome：

Mean Arterial Pressure

Type：

Primary indicator

测量时间点：

T0（患者进入内镜室时）T1（注射环泊酚1 min后）T2 （胃镜通过食管入口平面时）T3（胃镜退出后即刻）T4 （患者均完全清醒时）

测量方法：

生命体征连续监测

Measure time point of outcome：

T0: Baseline (Endoscopy Room Entry) T1: 1-min Post-ciprofol Injection T2: Gastroscope Passing Esophageal Entrance T3: Immediate Post-procedure (Scope Withdrawal) T4: Full Alertness / Recovery

Measure method：

Continuous vital signs monitoring

指标中文名：

心率

指标类型：

主要指标

Outcome：

Heart Rate

Type：

Primary indicator

测量时间点：

T0（患者进入内镜室时）T1（注射环泊酚1 min后）T2 （胃镜通过食管入口平面时）T3（胃镜退出后即刻）T4 （患者均完全清醒时）

测量方法：

生命体征连续监测

Measure time point of outcome：

T0: Baseline (Endoscopy Room Entry) T1: 1-min Post-ciprofol Injection T2: Gastroscope Passing Esophageal Entrance T3: Immediate Post-procedure (Scope Withdrawal) T4: Full Alertness / Recovery

Measure method：

Continuous vital signs monitoring

指标中文名：

血氧饱和度

指标类型：

主要指标

Outcome：

Oxygen Saturation

Type：

Primary indicator

测量时间点：

T0（患者进入内镜室时）T1（注射环泊酚1 min后）T2 （胃镜通过食管入口平面时）T3（胃镜退出后即刻）T4 （患者均完全清醒时）

测量方法：

生命体征连续监测

Measure time point of outcome：

T0: Baseline (Endoscopy Room Entry) T1: 1-min Post-ciprofol Injection T2: Gastroscope Passing Esophageal Entrance T3: Immediate Post-procedure (Scope Withdrawal) T4: Full Alertness / Recovery

Measure method：

Continuous vital signs monitoring

指标中文名：

呼吸频率

指标类型：

主要指标

Outcome：

Respiratory Rate

Type：

Primary indicator

测量时间点：

T0（患者进入内镜室时）T1（注射环泊酚1 min后）T2 （胃镜通过食管入口平面时）T3（胃镜退出后即刻）T4 （患者均完全清醒时）

测量方法：

生命体征连续监测

Measure time point of outcome：

T0: Baseline (Endoscopy Room Entry) T1: 1-min Post-ciprofol Injection T2: Gastroscope Passing Esophageal Entrance T3: Immediate Post-procedure (Scope Withdrawal) T4: Full Alertness / Recovery

Measure method：

Continuous vital signs monitoring

指标中文名：

低血压

指标类型：

主要指标

Outcome：

hypotension

Type：

Primary indicator

测量时间点：

胃镜麻醉期间及术后恢复期

测量方法：

SBP<90mmHg 或 SBP 较基线下降 30%以上，MAP<60mmHg 或 MAP 较基线下降 30%以上

Measure time point of outcome：

during the sedated gastroscopy procedure and in the post-procedure recovery period

Measure method：

Hypotension was defined as either (1) systolic blood pressure (SBP) < 90 mmHg or a decrease of >30% from baseline, or (2) mean arterial pressure (MAP) < 60 mmHg or a decrease of >30% from baseline.

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：

胃镜麻醉期间及术后恢复期

测量方法：

呼吸频率<8次/分或SpO2<90%

Measure time point of outcome：

during the sedated gastroscopy procedure and in the post-procedure recovery period

Measure method：

Respiratory depression was defined as a respiratory rate < 8 breaths per minute or SpO? < 90%

指标中文名：

心动过缓

指标类型：

主要指标

Outcome：

bradycardia

Type：

Primary indicator

测量时间点：

胃镜麻醉期间及术后恢复期

测量方法：

HR<50次/min

Measure time point of outcome：

during the sedated gastroscopy procedure and in the post-procedure recovery period

Measure method：

Bradycardia was defined as a heart rate (HR) < 50 beats per minute.

指标中文名：

心动过速

指标类型：

主要指标

Outcome：

tachycardia

Type：

Primary indicator

测量时间点：

胃镜麻醉期间及术后恢复期

测量方法：

HR＞100次/min

Measure time point of outcome：

during the sedated gastroscopy procedure and in the post-procedure recovery period

Measure method：

Tachycardia was defined as a heart rate (HR) > 100 beats per minute.

指标中文名：

恶心

指标类型：

主要指标

Outcome：

nausea

Type：

Primary indicator

测量时间点：

胃镜麻醉期间及术后恢复期

测量方法：

是一种特定的主观感觉，被定义为胃部不适和饱胀感，通常是呕吐的前奏，伴有流涎和反复的吞咽动作

Measure time point of outcome：

during the sedated gastroscopy procedure and in the post-procedure recovery period

Measure method：

Nausea is defined as a specific subjective sensation characterized by epigastric discomfort and a sensation of fullness, often serving as a precursor to vomiting, and accompanied by hypersalivation and repetitive swallowing movements.

指标中文名：

呕吐

指标类型：

主要指标

Outcome：

vomiting

Type：

Primary indicator

测量时间点：

胃镜麻醉期间及术后恢复期

测量方法：

被定义为强烈的重复吞咽动作，为胃的强烈反射性收缩以及胃内容物通过口腔从胃和食道快速排出

Measure time point of outcome：

during the sedated gastroscopy procedure and in the post-procedure recovery period

Measure method：

Vomiting is defined as a strong, reflexive contraction of the stomach, leading to the forceful and rapid expulsion of gastric contents through the mouth, preceded by intense, repeated swallowing motions.

指标中文名：

呃逆

指标类型：

主要指标

Outcome：

hiccups

Type：

Primary indicator

测量时间点：

胃镜麻醉期间及术后恢复期

测量方法：

定义为膈肌不自主的痉挛性收缩伴特征性声响

Measure time point of outcome：

during the sedated gastroscopy procedure and in the post-procedure recovery period

Measure method：

Hiccups are defined as a symptom characterized by involuntary, spasmodic contractions of the diaphragm and intercostal muscles, followed by the sudden, simultaneous closure of the glottis, which produces the characteristic "hic" sound.

指标中文名：

静脉注射痛

指标类型：

主要指标

Outcome：

pain during intravenous injection

Type：

Primary indicator

测量时间点：

胃镜麻醉期间及术后恢复期

测量方法：

给药后患者同侧上肢躲闪或诉注射部位疼痛

Measure time point of outcome：

during the sedated gastroscopy procedure and in the post-procedure recovery period

Measure method：

Pain upon intravenous injection was defined as either (1) observable withdrawal or flinching of the ipsilateral arm, or (2) a patient’s verbal complaint of pain at the injection site, occurring during or immediately after drug administration.

指标中文名：

术中知晓

指标类型：

主要指标

Outcome：

intraoperative awareness

Type：

Primary indicator

测量时间点：

胃镜麻醉期间及术后恢复期

测量方法：

术中知晓是指全身麻醉下的患者在手术过程中存在有意识的回忆，通常是对听觉事件（如对话声、仪器声）的记忆，可能伴有疼痛感、无助感等痛苦体验。

Measure time point of outcome：

during the sedated gastroscopy procedure and in the post-procedure recovery period

Measure method：

Intraoperative awareness is defined as the conscious recall of sensory perceptions (most commonly auditory) occurring during general anesthesia, which may be associated with feelings of pain, paralysis, or distress.

指标中文名：

术后谵妄

指标类型：

主要指标

Outcome：

postoperative delirium

Type：

Primary indicator

测量时间点：

胃镜麻醉期间及术后恢复期

测量方法：

术后谵妄是指手术后出现的急性、波动性意识与认知功能障碍。核心特征包括：注意力无法集中、思维混乱、意识水平改变（如过度警觉或嗜睡），以及可能出现幻觉或妄想。通常起病急，病程呈波动性。

Measure time point of outcome：

during the sedated gastroscopy procedure and in the post-procedure recovery period

Measure method：

Postoperative delirium is an acute and fluctuating disturbance in attention, awareness, and cognition that develops postoperatively. It is characterized by inattention, disorganized thinking, and an altered level of consciousness, and may involve perceptual disturbances (e.g., hallucinations).

指标中文名：

镇静成功率

指标类型：

次要指标

Outcome：

success rate of sedation

Type：

Secondary indicator

测量时间点：

胃镜麻醉期间及术后恢复期

测量方法：

镇静成功率，定义为 a） 完成整个内窥镜检查程序;b） 不需要抢救镇静药物;c） 初始剂量后 15 分钟内最多额外 5 剂; 镇静成功率= n (镇静患者) / n (入组患者)。

Measure time point of outcome：

during the sedated gastroscopy procedure and in the post-procedure recovery period

Measure method：

Sedation success rate is defined as the proportion of patients who meet all of the following three criteria: a) Completion of the entire endoscopic procedure. b) No requirement for rescue sedative medication. c) No more than 5 additional doses administered within 15 minutes following the initial dose. Sedation success rate = n (successfully sedated patients) / n (total enrolled patients).

指标中文名：

完全清醒的时间

指标类型：

次要指标

Outcome：

time to full awakening

Type：

Secondary indicator

测量时间点：

胃镜麻醉期间及术后恢复期

测量方法：

完全清醒的时间，定义为从"停止使用镇静剂"至"轻唤患者睁眼并可离开手术室进行安全转运"的时间间隔;

Measure time point of outcome：

during the sedated gastroscopy procedure and in the post-procedure recovery period

Measure method：

Time to full alertness is defined as the time interval from discontinuation of sedative administration to the point when the patient opens eyes in response to gentle verbal prompting and meets criteria for safe transfer from the operating room.

指标中文名：

意识丧失时间

指标类型：

次要指标

Outcome：

time to loss of consciousness

Type：

Secondary indicator

测量时间点：

胃镜麻醉期间及术后恢复期

测量方法：

意识丧失时间，定义为"镇静药物注射开始"和"患者睫毛反射消失"之间的时间间隔;

Measure time point of outcome：

during the sedated gastroscopy procedure and in the post-procedure recovery period

Measure method：

Time to loss of consciousness is defined as the time interval between the initiation of sedative drug injection and the loss of eyelash reflex in the patient.

指标中文名：

准备出院的时间

指标类型：

次要指标

Outcome：

time to discharge readiness

Type：

Secondary indicator

测量时间点：

胃镜麻醉期间及术后恢复期

测量方法：

准备出院时间，定义为患者完全苏醒至符合离院标准的时间。 [改良麻醉后出院评分系统评分≥9，在生命体征项目中有2分];

Measure time point of outcome：

during the sedated gastroscopy procedure and in the post-procedure recovery period

Measure method：

Time to discharge readiness is defined as the time interval from when the patient is fully alert to when they meet the criteria for discharge from the post-anesthesia care unit, specifically achieving a score of ≥9 on the Modified Post-Anesthesia Discharge Scoring System, with a score of 2 in the vital signs category.

指标中文名：

患者、内窥镜医师和麻醉医师的满意度

指标类型：

次要指标

Outcome：

satisfaction levels of the patient, endoscopist, and anesthesiologist

Type：

Secondary indicator

测量时间点：

胃镜麻醉期间及术后恢复期

测量方法：

使用0到10的口头评价量表，0代表非常不满意，10代表非常满意。

Measure time point of outcome：

during the sedated gastroscopy procedure and in the post-procedure recovery period

Measure method：

Satisfaction for all items was assessed using a 0 to 10 verbal rating scale, where 0 represents "very dissatisfied" and 10 represents "very satisfied".

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 65 岁 years
最大 Max age 80 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）：

使用SPSS 21.0产生随机数字表，根据随机数字表随机分为环泊酚组(C2组)和丙泊酚组(P2组)。

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

Randomization was performed using SPSS 21.0 to generate a random number sequence. Based on this sequence, participants were randomly allocated to either the Ciprofol group (Group C2) or the Propofol group (Group P2).

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：

在这项两步研究中，第一步进行了随机、双盲、单臂研究。60例研究对象按随机数字表法随机分为环泊酚序贯组(C1组,n=30)和丙泊酚序贯组(P1组,n=30),采用改良 Dixon’s 序贯法于8个有效-无效折返时停止研究,分别计算复合阿芬太尼7 μg/kg时环泊酚和丙泊酚抑制胃镜置入反应的ED50和ED95。第二步是一项随机对照双盲试验，按照随机数字表将120例受试者1:1纳入环泊酚组(C2组,n=60)和丙泊酚组(P2组,n=60)。其中参与者根据随机数字表被分配到环泊酚组（C2组）或丙泊酚组（P2组）。受试者患者不知道自己被分配到哪一组，而试验实施者由 2 名麻醉师完成，1 名麻醉师负责给药和麻醉管理，另一名麻醉师负责记录生命体征和不良反应。

Blinding：

In this two-step study, the first step involved a randomized, double-blind, single-arm dose-finding study. A total of 60 participants were randomly assigned via a random number table to either the Ciprofol sequential group (Group C1, n=30) or the Propofol sequential group (Group P1, n=30). Using a modified Dixon's up-and-down sequential design, the study for each group was stopped after eight positive-negative response reversals. The ED₅₀ and ED₉₅ of ciprofol and propofol, combined with alfentanil 7 μg/kg, for suppressing the response to gastroscope insertion were calculated separately. The second step was a randomized controlled, double-blind trial. According to a random number table, 120 participants were enrolled in a 1:1 ratio into either the Ciprofol group (Group C2, n=60) or the Propofol group (Group P2, n=60). The participants were blinded to their group assignment. The trial procedures were carried out by two anesthesiologists: one was responsible for drug administration and anesthesia management, while the other, who remained blinded to the group allocation, was responsible for recording vital signs and adverse events.

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：

所有研究数据将根据方案，由经过培训的麻醉医生记录于专用的病例报告表中。生命体征、不良事件等关键数据将在检查时当场记录。患者及内镜医师满意度等指标将使用标准化的口头评分量表进行采集。

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

All study data will be recorded in designated Case Report Forms (CRFs) by trained research personnel in accordance with the protocol. Critical data, such as vital signs and adverse events, will be recorded at the time of the visit. Outcomes such as patient and endoscopist satisfaction will be assessed using standardized verbal rating scales.

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：

  2026-01-26 08:21:18
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