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Ciprofol Sedation in Patients Undergoing Liver Cancer Percutaneous Radiofrequency Ablation

NCT ID: NCT06178926

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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.

Conditions

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Liver Cancer Ciprofol

Keywords

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Radiofreqency ablation Liver Cancer Ciprofol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

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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

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Diprivan Propoven HSK3486

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wang Jiangling

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiangling Wang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaochun Jin, MD.

Role: CONTACT

Phone: +86 571-88122564

Email: [email protected]

Facility Contacts

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Xiaochun Jin, M.D.

Role: primary

Jiangling Wang, Ph.D

Role: backup

Other Identifiers

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IRB-2023-350

Identifier Type: -

Identifier Source: org_study_id