Ciprofol Sedation in Patients Undergoing Liver Cancer Percutaneous Radiofrequency Ablation

Not Applicable

Recruiting

• Conditions: Liver Cancer; Ciprofol
• Interventions: Drug: Propofol; Drug: Ciprofol

• Registration Number: NCT06178926
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2023-07-25
• Study Start: 2023-08-01
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-20
• Last Update Submitted: 2023-12-20
• Study First Posted: 2023-12-21
• Last Update Posted: 2023-12-21
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	Use propofol for sedation during anesthesia.
Ciprofol	Ciprofol	Use ciprofol for sedation during anesthesia

Primary Outcome Measures

Name	Time	Method
Sedation efficacy	From the start of propofol/ciprofol injection to 4 min after sedation.	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.

Secondary Outcome Measures

Name	Time	Method
Respiratory depression	From the injection of propofol/ciprofol to the period patient return to the ward, an average of 2 hours.	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.
Injection pain	From the injection of propofol/ciprofol to the end of the surgery, an average of 1 hour.	Pain during injection of propofol/ciprofol

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China