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

NCT07081477 | Not Yet Recruiting DMC

• 1 other identifier: KY-20250307002-01
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Objective:
2. 2.Design:
3. 3.Participants:
4. 4.Key Assessments:
5. 5.Statistical Analysis:

Conditions

Ciprofol

Keywords

Painless colonoscopy; Propofol; Left Ventricular Outflow Tract Velocity Time Integral

Outcome Measures

Primary Outcomes (1)

• Left ventricular outflow tract velocity time integral

  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.

  Two minutes after administration

Secondary Outcomes (10)

• Left ventricular outflow tract velocity time integral

  Perioperative

• Left ventricular ejection fraction

  Perioperative

• Inferior Vena Cava Collapse Index

  Perioperative

• adverse event

  Perioperative

• Induction time

  Perioperative

Study Arms (2)

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

EXPERIMENTAL

Group C

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 P

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

Interventions

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.

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

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.

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

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First People's Hospital of Lianyungang: lead

MeSH Terms

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol

Central Study Contacts

zhibin Zhao

CONTACT

18961326661; lygzhaozhibin@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 23, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share