Ciprofol Sedation in Patients Undergoing Liver Cancer Percutaneous Radiofrequency Ablation

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06178926
• Other study ID #: IRB-2023-350
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: Zhejiang Cancer Hospital
• Contact: Xiaochun Jin, MD.
• Phone: +86 571-88122564
• Email: ec[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• Propofol
Propofol was IV infused 1.0-1.5mg/Kg and then maintenance at 1.0-2.0mg/Kg/h
• Ciprofol
Ciprofol was IV infused 0.2- 0.3mg/Kg and then maintenance at 0.2-0.3mg/Kg/h

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.