Ciprofol Sedation in Patients Undergoing Liver Cancer Percutaneous Radiofrequency Ablation

Efficacy and Safety of Ciprofol Sedation in Patients Undergoing Liver Cancer Percutaneous Radiofrequency Ablation: A Double-Blind, Randomized, Noninferiority Trial

Efficacy and Safety of Ciprofol Sedation in Patients Undergoing Liver Cancer Percutaneous Radiofrequency Ablation

Study Overview

• Status: Recruiting
• Conditions: Liver Cancer; Ciprofol
• Intervention / Treatment: Drug: Propofol; Drug: Ciprofol

Detailed Description

Ciprofol was injected before ablation and sedation scores were measured to make sure certain sedation.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaochun Jin, MD.; Phone Number: +86 571-88122564; Email: ec@zjcc.org.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Xiaochun Jin, M.D.; Phone Number: +86 571-88122564; Email: ec@zjcc.org.cn
      • Contact: Jiangling Wang, Ph.D; Phone Number: +86 571 88122106; Email: wangjl@zjcc.org.cn

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients who intend to undergoing ultrasound-guided percutaneous radiofrequency ablation of liver tumors;
• Age: 18-75 years old;
• ASA grade I-III;
• Laboratory examination meets the following conditions: neutrophils >1.5×109/L, platelet >80×109/L, hemoglobin >90g/L, aspartate transferase <1.5×ULN, total bilirubin <1.5×ULN, serum creatinine <1.2 x ULN;
• Chemotherapy < 4 times.

Exclusion Criteria:

• Patients who are known to be allergic to propofol, opioids, eggs, soy products, or patients who are contraindicated with these drugs or foods due to illness;
• serious organ dysfunction and other systemic diseases, such as liver dysfunction, renal dysfunction; Worsening congestive heart failure within the last 6 months resulting in hospitalization or adjustment of medication; Severe aortic or mitral stenosis; Heart surgery (heart valve replacement) within the last 6 months; Acute myocardial infarction in the last 6 months; Hemodynamic disturbance due to arrhythmia; Respiratory diseases; Cerebrovascular diseases; . Taking propofol, opioids or other analgesic and sedative drugs 72 hours before . Emergency surgery;
• Those who are unable to communicate with the researcher normally or who are deemed unsuitable by the researcher and refuse to participate in the study.

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
Active Comparator: Propofol; Use propofol for sedation during anesthesia.	Drug: Propofol; Propofol was IV infused 1.0-1.5mg/Kg and then maintenance at 1.0-2.0mg/Kg/h; Other Names: Diprivan; Propoven
Experimental: Ciprofol; Use ciprofol for sedation during anesthesia	Drug: Ciprofol; Ciprofol was IV infused 0.2- 0.3mg/Kg and then maintenance at 0.2-0.3mg/Kg/h; Other Names: HSK3486

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation efficacy	Satisfaction assessed by MOAAS, Modified Observer's Assessment of Alertness and Sedation (MOAA/S) scale is a validated 6-point scale assessing responsiveness of patients coinciding with the American Society of Anesthesiologists (ASA) continuum of sedation. MOAA/S 0 to 1 represent deeper sedation, MOAA/S 2 to 3 represent moderate sedation and MOAA/S 4 to 5 represent lighter to no sedation. In this study, MOAAS between 2-3 after initial IV dosage of propofol/ciprofol was defined as efficacy sedation.	From the start of propofol/ciprofol injection to 4 min after sedation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory depression	Any respiratory depression from the injection of propofol/ciprofol to fully recovery after surgery. Respiratory depression was defined as respiratory rate less than 10 times/min or the oxygen saturation decrease more than 5% compared with the baseline value.	From the injection of propofol/ciprofol to the period patient return to the ward, an average of 2 hours.
Injection pain	Pain during injection of propofol/ciprofol	From the injection of propofol/ciprofol to the end of the surgery, an average of 1 hour.

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: Jiangling Wang, Dr., Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Estimated): December 21, 2023

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Liver Cancer; Ciprofol; Radiofreqency ablation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: IRB-2023-350

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study protocol will be shared when asked

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No