Ciprofol Sedation in Patients Undergoing Liver Cancer Percutaneous Radiofrequency Ablation

NCT ID: NCT06178926

Last Updated: 2023-12-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-12-30

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.

Conditions

Liver Cancer; Ciprofol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Propofol

Use propofol for sedation during anesthesia.

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Propofol was IV infused 1.0-1.5mg/Kg and then maintenance at 1.0-2.0mg/Kg/h

Ciprofol

Use ciprofol for sedation during anesthesia

Group Type: EXPERIMENTAL

Ciprofol

Intervention Type: DRUG

Ciprofol was IV infused 0.2- 0.3mg/Kg and then maintenance at 0.2-0.3mg/Kg/h

Interventions

Propofol

Propofol was IV infused 1.0-1.5mg/Kg and then maintenance at 1.0-2.0mg/Kg/h

Intervention Type: DRUG

Ciprofol

Ciprofol was IV infused 0.2- 0.3mg/Kg and then maintenance at 0.2-0.3mg/Kg/h

Intervention Type: DRUG

Other Intervention Names

Diprivan; Propoven; HSK3486

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wang Jiangling

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiangling Wang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaochun Jin, MD.

Role: CONTACT

ec@zjcc.org.cn

+86 571-88122564

Facility Contacts

Xiaochun Jin, M.D.

Role: primary

ec@zjcc.org.cn

+86 571-88122564

Jiangling Wang, Ph.D

Role: backup

wangjl@zjcc.org.cn

+86 571 88122106

Other Identifiers

IRB-2023-350

Identifier Type: -

Identifier Source: org_study_id