Effect of Ciprofol on Left Ventricular Outflow Tract Velocity-Time Integral in Elderly Patients Undergoing Painless Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Left ventricular outflow tract velocity time integral
研究概览
简要总结
- Objective:
Primary: Compare the effect of Ciprofol vs Propofol on LVOT VTI at 2 minutes post-injection (T1) in elderly patients (≥65 years).
Secondary: Assess hypotension incidence, injection pain, nausea/vomiting, hypoxia (SpO₂≤90%), bradycardia (HR<50 bpm), sedation success rate, induction/recovery times, procedure duration, drug doses, and patient satisfaction. 2. Design:
Single-center, randomized, double-blind, controlled trial. Group C (Ciprofol):0.2-0.5 mg/kg IV induction (>30s injection). Group P (Propofol)::1-2 mg/kg IV induction (>30s injection). Rescue doses allowed (C: 0.1 mg/kg; P: 0.5 mg/kg; max 5 doses/15 min). 3. Participants:
N = 120 elderly patients (65-80 years, ASA I-III, BMI 18-30 kg/m²) scheduled for elective painless colonoscopy.
Exclusion: Significant cardiorespiratory, hepatic, renal, or neurological disorders; recent MI/unstable angina (≤6 months); NYHA ≥II; drug allergies; recent trial participation. 4. Key Assessments:
Primary Endpoint: LVOT VTI (via transthoracic echocardiography, TTE) at T1.
Secondary Endpoints:
Adverse events (hypotension, pain, nausea/vomiting, hypoxia, bradycardia, body movement, awareness).
Sedation success rate, induction/recovery times (MOAA/S scale), procedure time. Drug doses (induction, total, vasoactive agents). Patient satisfaction (5-point scale). LVEF and IVC Collapse Index (TTE at T0, T1, T2). Safety: Vital signs (HR, BP, SpO₂). 5. Statistical Analysis:
SPSS 26.0; α=0.05. Methods: t-test, RM-ANOVA, Mann-Whitney U, Chi-square/Fisher's exact, rank-sum tests.
This study aims to determine whether Ciprofol provides superior hemodynamic stability (as measured by LVOT VTI) and fewer adverse effects compared to Propofol for sedation in elderly patients undergoing painless colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA classification I-III;
- •Age ≥65 years and ≤80 years;
- •BMI between 18-30 kg/m2 (including the threshold);
- •Patients undergoing painless colonoscopy on an elective basis;
- •Subjects voluntarily participated in this study and signed an informed consent form.
排除标准
- •Those with respiratory depression or high risk of respiratory depression (e.g., sleep apnea syndrome, bronchial asthma, etc.);
- •Suffering from major diseases such as severe hepatic and renal insufficiency, neurological and psychiatric systems;
- •Suffering from severe arrhythmias such as severe aortic regurgitation, atrial fibrillation, tachycardia (heart rate > 120 beats/minute), atrioventricular block of degree II and above, myocardial infarction or unstable angina within 6 months before the examination, and NYHA classification grade II and above;
- •Allergy to or abuse of any medication used in the study;
- •Participation in another clinical trial within the last 3 months.
研究组 & 干预措施
During anesthesia induction, ciprofol 0.2-0.5 mg/kg was intravenously injected (injection rate > 30s
Group C
干预措施: Intravenous Anesthetic Induction with Ciprofol for Painless Colonoscopy in Elderly Patients (Drug)
During anesthesia induction, propofol 1-2 mg/kg was intravenously injected (injection rate > 30s).
Group P
干预措施: Propofol Intravenous Anesthesia Induction for Painless Colonoscopy in Elderly Patients (Drug)
结局指标
主要结局
Left ventricular outflow tract velocity time integral
时间窗: Two minutes after administration
The patient is in the left lateral position, using the same ultrasound equipment with standardized settings (gain, depth, frequency). Transthoracic Doppler echocardiography measurements are taken at the end of expiration.
次要结局
- Left ventricular outflow tract velocity time integral(Perioperative)
- Left ventricular ejection fraction(Perioperative)
- Inferior Vena Cava Collapse Index(Perioperative)
- adverse event(Perioperative)
- Induction time(Perioperative)
- Procedure time(Perioperative)
- Awakening time(Perioperative)
- Induction drug dose , additional dose , total dose and vasoactive drug dose(Perioperative)
- Sedation success rate(Perioperative)
- Patient satisfaction(Perioperative)