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RecruitingNCT06178926Updated Dec 21, 2023

Ciprofol Sedation in Patients Undergoing Liver Cancer Percutaneous Radiofrequency Ablation

An interventional study of Propofol and Ciprofol in Liver Cancer and Ciprofol, sponsored by Zhejiang Cancer Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-21.

Sponsored by Zhejiang Cancer Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Liver Cancer
  • Ciprofol

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Keywords

  • Radiofreqency ablation
  • Liver Cancer
  • Ciprofol
03

In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's planned enrollment of 80 is above the median of 47 across 968 interventional studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

Zhejiang Cancer Hospital is the lead sponsor of 271 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Propofol

    Use propofol for sedation during anesthesia.

    Drug: Propofol

  • Experimental
    Ciprofol

    Use ciprofol for sedation during anesthesia

    Drug: Ciprofol

Interventions

  • DrugPropofol

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

    Also known as: Diprivan, Propoven

  • DrugCiprofol

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

    Also known as: HSK3486

06

What researchers measure

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.

    Time frame: From the start of propofol/ciprofol injection to 4 min after sedation.

Secondary outcomes

  1. 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.

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

  2. Injection pain

    Pain during injection of propofol/ciprofol

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

07

Study locations

1 of 1 sites recruiting
  • Zhejiang Cancer Hospital
    Hangzhou, Zhejiang 310022, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Study protocol will be shared when asked

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06178926
Lead sponsor
Zhejiang Cancer Hospital
Responsible party
Wang Jiangling (Principle Investigator, Zhejiang Cancer Hospital) — Principal investigator
First posted
Dec 21, 2023
Start date
Aug 1, 2023
Primary completion
Dec 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Dec 21, 2023

Study contacts

Xiaochun Jin, MD.
Contact
ec@zjcc.org.cn
+86 571-88122564
Jiangling Wang, Dr.
principal investigator · Zhejiang Cancer Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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