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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
120
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.
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.
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.
Time frame: Two minutes after administration
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.
Time frame: Perioperative
Left ventricular ejection fraction
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.
Time frame: 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%.
Time frame: 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.
Time frame: Perioperative
Induction time
Time from initial administration to Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤1.
Time frame: Perioperative
Procedure time
The duration from colonoscopy insertion to withdrawal.
Time frame: Perioperative
Awakening time
The time from the end of the last administration to MOAA/S score equaling 5.
Time frame: Perioperative
Induction drug dose , additional dose , total dose and vasoactive drug dose
Time frame: 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.
Time frame: Perioperative
Patient satisfaction
Patient satisfaction with anesthesia is divided into five options: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.
Time frame: Perioperative
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