Ciprofol Sedation in Patients Undergoing Liver Cancer Percutaneous Radiofrequency Ablation

Study Overview
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Brief Summary
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Efficacy and Safety of Ciprofol Sedation in Patients Undergoing Liver Cancer Percutaneous Radiofrequency Ablation

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

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

Conditions
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Liver Cancer, Ciprofol

Intervention / Treatment
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* Drug: Propofol
* Drug: Ciprofol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>Use propofol for sedation during anesthesia. | Drug: Propofol<br>* Propofol was IV infused 1.0-1.5mg/Kg and then maintenance at 1.0-2.0mg/Kg/h<br>* Other names: Propoven;|
| Experimental: Ciprofol<br>Use ciprofol for sedation during anesthesia | Drug: Ciprofol<br>* Ciprofol was IV infused 0.2- 0.3mg/Kg and then maintenance at 0.2-0.3mg/Kg/h<br>* Other names: HSK3486;|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiofreqency ablation, Liver Cancer, Ciprofol