NCT07081477

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: The First People's Hospital of Lianyungang · Academic / Other
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Ciprofol

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2025-08-25
• Primary completion: 2027-06-01
• Completion: 2027-06-30
• First posted: 2025-07-23
• Last updated: 2025-07-23