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

NCT07081477 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The First People's Hospital of Lianyungang

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2027-06-01
Completion
2027-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07081477 on ClinicalTrials.gov