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

NCT ID: NCT07081477

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-25
• Study Completion Date: 2027-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group C

Group Type: EXPERIMENTAL

Intravenous Anesthetic Induction with Ciprofol for Painless Colonoscopy in Elderly Patients

Intervention Type: 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.

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

Group P

Group Type: ACTIVE_COMPARATOR

Propofol Intravenous Anesthesia Induction for Painless Colonoscopy in Elderly Patients

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The First People's Hospital of Lianyungang

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

zhibin Zhao

Role: CONTACT

lygzhaozhibin@163.com

18961326661

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

KY-20250307002-01

Identifier Type: -

Identifier Source: org_study_id