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

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.

Study Overview

• Status: Recruiting
• Conditions: Transcatheter Aortic Valve Replacement; General Anesthesia; Hemodynamics; Post-induction Hypotension
• Intervention / Treatment: Drug: ciprofol; Drug: propofol

Detailed Description

After assessing patient eligibility, they were randomly assigned to two equally sized groups.Patients in this study were fasted for a minimum of 8 h without premedication.

Following arrival in the operating room, patients were monitored with electrocardiography, respiratory rate, pulse oximetry, bispectral index (BIS), cerebral oxygen saturation,and continuous invasive arterial blood pressure. 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； 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.

Endotracheal intubation was performed when alfentanil and rocuronium had fully worked, and the BIS value was <50. A ventilator was then connected for mechanical ventilation using the following parameters: VT 6-8 ml/kg, RR 12-20 times/min, the inspiratory-to-expiratory ratio of 1:2, oxygen flowed 2 L/min, and maintaining PETCO2 at 35-45 mmHg (1 mmHg=0.133 kPa).

Maintenance of anesthesia:

group ciprofol received an IV infusion of ciprofol 0.8-2.4 mg·kg-1·h-1； group propofol received an IV infusion of propofol 4-6 mg·kg-1·h-1 .

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University anesthesiology department
      • Principal Investigator: Min Yan, Doctor
      • Contact: Min Yan, Doctor; Phone Number: 15888210247; Email: zryanmin@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group ciprofol; Patients receive ciprofol for general anesthesia	Drug: ciprofol; 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.; Other Names: alfentanil
Active Comparator: group propofol; Patients receive propofol for general anesthesia	Drug: propofol; 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.; Other Names: alfentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypotension	Hemodynamic variable	within 15 minutes after induction of anesthesia
Incidence of bradycardia	Hemodynamic variable	within 15 minutes after induction of anesthesia
dose of vasopressor used within 15 minutes after induction of anesthesia and vasopressor drugs used during surgery	Hemodynamic variable	during the surgery
Incidence of injection pain	injection pain	during the induction of anesthesia procedure
Incidence of postoperative nausea and vomiting	drug reaction	1 day (during anesthesia awakening)
Quality of life and disease recovery (QoR-15) score on postoperative day 1	postoperative evaluation	1 day after surgery
changes of CK-MB and cTnT before and one first day after surgery	myocardial enzyme level	immediately before surgery and one first day after surgery
changes of IL-6 before and one first day after surgery	inflammatory factor level	immediately before surgery and one first day after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2023
• Primary Completion (Estimated): May 25, 2024
• Study Completion (Estimated): June 25, 2024

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: general anesthesia; ciprofol; transcatheter aortic valve replacement
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Propofol; Alfentanil
• Other Study ID Numbers: 2023-0135 (Other Identifier: M D Anderson Cancer Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No