Dexmedetomidine-esketamine for Percutaneous Radiofrequency Liver Ablation

NCT06003218 | Completed DMC

• 1 other identifier: 2023-276
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Percutaneous radiofrequency ablation is a commonly treatment for patients with liver cancer that cannot be surgically resected. During the procedure, patients need to keep awake and cooperate with the procedure, including deep breath and hold breath. However, intolerable pain generated during puncture and radiofrequency heating may cause body movements and interfere the procedure. Oxycodone is frequently used for analgesia but still insufficient. A recent study showed that dexmedetomidine-esketamine combination improves analgesia without increasing adverse events. After stopping infusion, the analgesic/sleep-promoting effects of dexmedetomidine-esketamine seemed to last for up to 24 hours. The investigators hypothesize that dexmedetomidine-esketamine combination as a supplement to oxycodone will improve sedation and analgesia in patients undergoing radiofrequency liver ablation of the liver.

Conditions

Liver Cancer; Radiofrequency Ablation; Esketamine; Dexmedetomidine

Keywords

Liver cancer; Radiofrequency ablation; Esketamine; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Area under curve of Numerical Rating Scale of pain during and within 24 hours after surgery.

  Numerical Rating Scale (NRS, an 11-point scale where 0=no pain and 10=the worst pain) of pain will be assessed after percutaneous liver puncture, start of radiofrequency-ablation, every 5±1 minutes during radiofrequency-ablation, end of radiofrequency-ablation, and 10 minutes after needle removal during surgery, as well as at 0.5, 1, 2, 3-8, \>8-12h,and 24 hours after surgery.

  During and within 24 hours after surgery.

Secondary Outcomes (6)

• The highest Numerical Rating Scale of pain during surgery.

  During surgery.

• Number of intraoperative adjustment of study drug infusion rate.

  During surgery.

• Number of additional oxycodone or other analgesics during and within 24 hours after surgery.

  During and within 24 hours after surgery.

• Dose of analgesics during and within 24 hours after surgery.

  During and within 24 hours after surgery.

• Pain intensity and opioid consumption (PIOC) index during and within 24 hours after surgery.

  During and within 24 hours after surgery.

Other Outcomes (5)

• Patients' evaluation on anesthesia.

  Within 30 minutes after surgery.

• Surgeons' evaluation on anesthesia.

  Within 30 minutes after surgery.

• Postoperative recovery time.

  Up to 2 hours after surgery.

Study Arms (2)

Dexmedetomidine-esketamine combined with oxycodone

EXPERIMENTAL

Dexmedetomidine-esketamine combination will be infused in addition to oxycodone; the target is to maintain a Richmond Agitation and Sedation Scale between -2 and -1 during surgery.

Drug: Dexmedetomidine-esketamine combination; Drug: Oxycodone

Remifentanil combined with oxycodone

ACTIVE COMPARATOR

Remifentanil will be infused in addition to oxycodone; the target is to maintain a Richmond Agitation and Sedation Scale between -2 and -1 during surgery.

Drug: Remifentanil; Drug: Oxycodone

Interventions

Dexmedetomidine-esketamine combination DRUG

Dexmedetomidine-esketamine mixture will be infused with doses adjusted to maintain a Richmond Agitation-Sedation Scale between -2 to -1 during surgery.

Dexmedetomidine-esketamine combined with oxycodone

Remifentanil DRUG

Remifentanil will be infused with doses adjusted to maintain a Richmond Agitation-Sedation Scale between -2 to -1 during surgery.

Remifentanil combined with oxycodone

Oxycodone DRUG

Oxycodone will be injected intravenously 10-15 min before puncture.

Dexmedetomidine-esketamine combined with oxycodone; Remifentanil combined with oxycodone

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years but ≤85 years.
• Scheduled for elective ultrasound-guided percutaneous radiofrequency ablation for primary or metastatic liver cancer.

You may not qualify if:

• Refused to participate.
• Diagnosed schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis before surgery.
• Preoperative left ventricular ejection fraction (LVEF) \<30%, or those with sick sinus syndrome, sinus bradycardia (heart rate \<50 beats per minute), or atrioventricular block at grade II or above without pacemaker.
• Diagnosed obstructive sleep apnea (OSA) or judged to be at high-risk of moderate-to-severe OSA before surgery.
• Severe liver dysfunction (Child-Pugh grade C), severe renal dysfunction (dialysis before surgery), or classified as American Society of Anesthesiologists (ASA) grade \>III before surgery.
• Inability to communicate due to coma, severe dementia, or language barrier before surgery.
• Allergy to any drug used during the study, or other conditions that are considered unsuitable for study participation.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (26)

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MeSH Terms

Conditions

Liver Neoplasms

Interventions

Remifentanil; Oxycodone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anesthesiology

Study Record Dates

• First Submitted: August 12, 2023
• First Posted: August 21, 2023
• Study Start: October 16, 2023
• Primary Completion: September 26, 2024
• Study Completion: September 28, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

CN (1)