Ciprofol Sedation in Patients Undergoing Liver Cancer Percutaneous Radiofrequency Ablation

NCT06178926 | Unknown DMC

• 1 other identifier: IRB-2023-350
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Cancer; Ciprofol

Keywords

Radiofreqency ablation; Liver Cancer; Ciprofol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Respiratory depression

  From the injection of propofol/ciprofol to the period patient return to the ward, an average of 2 hours.

• Injection pain

  From the injection of propofol/ciprofol to the end of the surgery, an average of 1 hour.

Study Arms (2)

Propofol

ACTIVE COMPARATOR

Use propofol for sedation during anesthesia.

Drug: Propofol

Ciprofol

EXPERIMENTAL

Use ciprofol for sedation during anesthesia

Drug: Ciprofol

Interventions

Propofol DRUG

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

Also known as: Diprivan, Propoven

Propofol

Ciprofol DRUG

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

Also known as: HSK3486

Ciprofol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Propofol; (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; HSK3486

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jiangling Wang, Dr.

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaochun Jin, MD.

CONTACT

+86 571-88122564; ec@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: December 21, 2023
• Study Start: August 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)