Efficacy and Safety of Ciprofol for General Anaesthesia in Patients Undergoing Transcatheter Aortic Valve Replacement

NCT05881291 | Completed Phase 4 DMC

• 1 other identifier: 2023-0135
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Aortic valve stenosis is the most common debilitating valvular heart lesion in old patients. Transcatheter aortic valve replacement (TAVR) is an emergent technique for high-risk patients with aortic stenosis. In recent times, treatment has expanded to also include low- and intermediate-risk individuals. General anesthesia offers many advantages, mainly regarding the possibility of an early diagnosis and treatment of possible complications through the use of transesophageal echocardiography. Propofol is the most used sedative-hypnotic agent for the induction and maintenance of general anesthesia. However, adverse events such as hypotension, and bradycardia are associated with propofol sedation. Ciprofol is a novel anesthetic/sedative agent similar to propofol, with an equivalent efficacy ratio to propofol of 1/4 to 1/5. Ciprofol has properties of fast onset of action, rapid recovery, reduced injection pain and stable cardiorespiratory function, making it a promising alternative to propofol. The aim of this study is to explore the safety and efficacy of ciprofol when used for general anesthesia in patients undergoing transcatheter aortic valve replacement compared to propofol.

Conditions

Hemodynamics; Transcatheter Aortic Valve Replacement; General Anesthesia; Post-induction Hypotension

Keywords

ciprofol; transcatheter aortic valve replacement; general anesthesia

Outcome Measures

Primary Outcomes (1)

• primary endpoint was the area under the curve below baseline MAP (MAP-time integral) during the 15 min after induction

  the area under the baseline MAP over the first 15 min after induction, called the MAP-time integral

  from the start of induction of anesthesia to 15 minutes after induction of anesthesia

Secondary Outcomes (9)

• Incidence of hypotension

  within 15 minutes after induction of anesthesia

• Incidence of bradycardia

  within 15 minutes after induction of anesthesia

• dose of vasopressor used within 15 minutes after induction of anesthesia and vasopressor drugs used during surgery

  during the surgery

• Incidence of injection pain

  during the induction of anesthesia procedure

• Incidence of postoperative nausea and vomiting

  1 day (during anesthesia awakening)

Study Arms (2)

group ciprofol

EXPERIMENTAL

Patients receive ciprofol for general anesthesia

Drug: ciprofol

group propofol

ACTIVE COMPARATOR

Patients receive propofol for general anesthesia

Drug: propofol

Interventions

ciprofol DRUG

induction of anesthesia：group ciprofol received an IV injection of ciprofol at a dose of 0.2-0.4 mg/kg, and administration time of 30 s.When the eyelash reflex disappeared and the BIS value was ≤60 administration was stopped, followed by an IV injection of alfentanil 30 μg/kg and rocuronium 0.6 mg/kg. Maintenance of anesthesia: group ciprofol received an IV infusion of ciprofol 0.8-2.4 mg·kg-1·h-1.

Also known as: alfentanil

group ciprofol

propofol DRUG

induction of anesthesia：group propofol received an IV injection of propofol at a dose of 1.0-2.0 mg/kg, and administration time of 30 s. When the eyelash reflex disappeared and the BIS value was ≤60 administration was stopped, followed by an IV injection of alfentanil 30 μg/kg and rocuronium 0.6 mg/kg. Maintenance of anesthesia:group propofol received an IV infusion of propofol 4-6 mg·kg-1·h-1.

Also known as: alfentanil

group propofol

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients planned for transfemoral transcatheter aortic valve replacement
• expected duration of surgery ≥ 1 and ≤ 3h
• patients undergoing general anesthesia
• no gender limit，age≥60 years，≤85 years
• BMI ≥18 and ≤30kg/m2
• ASA physical status 3\~4
• be able to understand the procedures and methods of the trial and voluntarily sign the informed consent form

You may not qualify if:

• predicted presence of difficult airway or previous history of difficult airway
• allergic to eggs, soy products, propofol, and opioids and their antidotes
• patients with shock or hypotension that is difficult to correct with vasopressor
• patients with mental, nervous system diseases, long-term use of sedatives or antidepressants
• HB \< 10.0 g/dL (100 g/L)
• patients with previous long-term use of sedative and analgesic drugs
• patients with severe heart，lung，liver and kidney disease
• not suitable for participation in this study as assessed by the investigator

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• Ni T, Zhou X, Wu S, Lv T, Hu Y, Gao Q, Luo G, Xie C, Zou J, Chen Y, Zhao L, Xiao J, Tao X, Yi Y, Xu Z, Wang T, Zhou J, Yao Y, Yan M. Hemodynamic Impact of Cipepofol vs Propofol During Anesthesia Induction in Patients With Severe Aortic Stenosis: A Randomized Clinical Trial. JAMA Surg. 2025 Jul 1;160(7):763-770. doi: 10.1001/jamasurg.2025.1299.

  PMID: 40397427 DERIVED

MeSH Terms

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; Alfentanil; Propofol

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 31, 2023
• Study Start: June 29, 2023
• Primary Completion: July 8, 2024
• Study Completion: July 8, 2024
• Last Updated: January 15, 2026

Record last verified: 2024-07

Locations

CN (1)