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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.
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).
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.
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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| During anesthesia induction, ciprofol 0.2-0.5 mg/kg was intravenously injected (injection rate > 30s | Experimental | Group C |
|
| During anesthesia induction, propofol 1-2 mg/kg was intravenously injected (injection rate > 30s). | Active Comparator | Group P |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Anesthetic Induction with Ciprofol for Painless Colonoscopy in Elderly Patients | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular outflow tract velocity time integral | 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. | Two minutes after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular outflow tract velocity time integral | 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. | Perioperative |
| Left ventricular ejection fraction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhibin Zhao | Contact | 18961326661 | lygzhaozhibin@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 1, 2025 |
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| Propofol Intravenous Anesthesia Induction for Painless Colonoscopy in Elderly Patients | Drug | 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. |
|
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. |
| Perioperative |
| Inferior Vena Cava Collapse Index | Measure the maximum internal diameter (IVCmax) at end-expiration and minimum internal diameter (IVCmin) at end-inspiration of the inferior vena cava 1-2 cm from the right atrial entrance by ultrasound, and calculate according to the formula (IVCmax - IVCmin)/IVCmax × 100%. | Perioperative |
| adverse event | The incidence of hypotension, injection pain, nausea, vomiting, hypoxemia (blood oxygen saturation ≤ 90%), bradycardia (heart rate < 50 beats per minute), body movement (unconscious limb movement of the patient), and intraoperative awareness. | Perioperative |
| Induction time | Time from initial administration to Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤1. | Perioperative |
| Procedure time | The duration from colonoscopy insertion to withdrawal. | Perioperative |
| Awakening time | The time from the end of the last administration to MOAA/S score equaling 5. | Perioperative |
| Induction drug dose , additional dose , total dose and vasoactive drug dose | Perioperative |
| Sedation success rate | The number of patients who received up to 5 supplemental doses within 15 minutes after completing colonoscopy, without requiring rescue sedation, following the initial dose. | Perioperative |
| Patient satisfaction | Patient satisfaction with anesthesia is divided into five options: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Perioperative |
| Jul 15, 2025 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| C000730795 | (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol |
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