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

The First People's Hospital of Lianyungang

Status: Not yet enrolling

Conditions: Ciprofol

Treatments: Drug: Propofol Intravenous Anesthesia Induction for Painless Colonoscopy in Elderly Patients; Drug: Intravenous Anesthetic Induction with Ciprofol for Painless Colonoscopy in Elderly Patients

Study type: Interventional

Funder types: Other

Identifiers

NCT07081477

KY-20250307002-01

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 65 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. ASA classification I-III;
2. Age ≥65 years and ≤80 years;
3. BMI between 18-30 kg/m2 (including the threshold);
4. Patients undergoing painless colonoscopy on an elective basis;
5. Subjects voluntarily participated in this study and signed an informed consent form.

Exclusion criteria

1. Those with respiratory depression or high risk of respiratory depression (e.g., sleep apnea syndrome, bronchial asthma, etc.);
2. Suffering from major diseases such as severe hepatic and renal insufficiency, neurological and psychiatric systems;
3. 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;
4. Allergy to or abuse of any medication used in the study;
5. Participation in another clinical trial within the last 3 months.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

During anesthesia induction, ciprofol 0.2-0.5 mg/kg was intravenously injected (injection rate > 30s

Experimental group

Description:

Group C

Treatment:

Drug: Intravenous Anesthetic Induction with Ciprofol for Painless Colonoscopy in Elderly Patients

During anesthesia induction, propofol 1-2 mg/kg was intravenously injected (injection rate > 30s).

Active Comparator group

Description:

Group P

Treatment:

Drug: Propofol Intravenous Anesthesia Induction for Painless Colonoscopy in Elderly Patients