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NCT Number: NCT07081477

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

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.

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Key information

Conditions

Ciprofol

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Intravenous Anesthetic Induction with Ciprofol for Painless Colonoscopy in Elderly Patients

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.

Propofol Intravenous Anesthesia Induction for Painless Colonoscopy in Elderly Patients

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.

Primary outcomes

  1. Left ventricular outflow tract velocity time integral

    Time frame: Two minutes after administration

    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.

Secondary outcomes

  1. Left ventricular outflow tract velocity time integral

    Time frame: Perioperative

    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.

  2. Left ventricular ejection fraction

    Time frame: Perioperative

    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.

  3. Inferior Vena Cava Collapse Index

    Time frame: Perioperative

    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%.

  4. adverse event

    Time frame: Perioperative

    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.

  5. Induction time

    Time frame: Perioperative

    Time from initial administration to Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤1.

  6. Procedure time

    Time frame: Perioperative

    The duration from colonoscopy insertion to withdrawal.

  7. Awakening time

    Time frame: Perioperative

    The time from the end of the last administration to MOAA/S score equaling 5.

  8. Induction drug dose , additional dose , total dose and vasoactive drug dose

    Time frame: Perioperative

  9. Sedation success rate

    Time frame: Perioperative

    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.

  10. Patient satisfaction

    Time frame: Perioperative

    Patient satisfaction with anesthesia is divided into five options: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.

Study contacts

Contact information is provided by the study sponsor or research team.

zhibin Zhao

CONTACT

[email protected]

18961326661

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Lianyungang

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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