Ciprofol's Influence on LVOT VTI in Elderly Painless Colonoscopy Patients

Официальное название

Effect of Ciprofol on Left Ventricular Outflow Tract Velocity-Time Integral in Elderly Patients Undergoing Painless Colonoscopy

Обзор

1. 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.

Вмешательства

• Препарат Intravenous Anesthetic Induction with Ciprofol for Painless Colonoscopy in Elderly Patients
  Cirpropofol is a 2,6-disubstituted phenol derivative that introduces a cyclopropyl group based on the chemical structure of propofol, increasing its affinity with GABA receptors and stereoeffect, thus its effect is 4-5 times that of propofol. Studies have found that the incidence of hypotension, injection pain, and respiratory depression during cirpropofol anesthesia is lower than that of propofol.
• Препарат Propofol Intravenous Anesthesia Induction for Painless Colonoscopy in Elderly Patients
  Propofol has favorable pharmacokinetic properties with minimal residue. Currently, it is widely used for endoscopic procedure sedation, but there are still many limitations, such as a narrow therapeutic window, injection pain, hypotension, and respiratory depression.

Первичные конечные точки

• Left ventricular outflow tract velocity time integral [Срок оценки: Two minutes after administration]

Вторичные конечные точки (10)

• Left ventricular outflow tract velocity time integral [Срок оценки: Perioperative]
• Left ventricular ejection fraction [Срок оценки: Perioperative]
• Inferior Vena Cava Collapse Index [Срок оценки: Perioperative]
• adverse event [Срок оценки: Perioperative]
• Induction time [Срок оценки: Perioperative]
• Procedure time [Срок оценки: Perioperative]
• Awakening time [Срок оценки: Perioperative]
• Induction drug dose , additional dose , total dose and vasoactive drug dose [Срок оценки: Perioperative]
• Sedation success rate [Срок оценки: Perioperative]
• Patient satisfaction [Срок оценки: Perioperative]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07081477 · KY-20250307002-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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