Dexmedetomidine-esketamine for Percutaneous Radiofrequency Liver Ablation

March 27, 2025 updated by: Dong-Xin Wang, Peking University First Hospital

Dexmedetomidine-esketamine Combined With Oxycodone for Ultrasound-guided Percutaneous Radiofrequency Ablation in Patients With Liver Cancer: a Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ultrasound-guided percutaneous radiofrequency ablation is a new technique to treat liver cancer. Under ultrasound guidance, a radiofrequency electrode needle is inserted into the cancer through which local high temperature is generated to coagulate and necrose the cancer tissue. Percutaneous radiofrequency ablation is currently recognized as the best 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 a widely used opioid. It activates the μ and κ receptors and relieves pain including visceral pain, which makes it suitable for analgesia during radiofrequency ablation. However, due to the strong stimulation of radiofrequency liver ablation, supplemental analgesics are often required to improve patient cooperation. As a commonly used supplement, remifentanil is also a μ receptor agonist that quickly reaches blood-brain balance in about 1 minute in and is rapidly hydrolyzed in tissues and blood. The problems with remifentanil are the ultra-short action and pain allergy after stopping infusion. The burning pain after percutaneous liver radiofrequency ablation may last for up to 24 hours.

Dexmedetomidine is a highly selective α2-adrenergic receptor agonist that has sedative, anxiolytic, and analgesic effects. Ketamine is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist that is widely used in pediatric anesthesia and postoperative analgesia. Recent studies found that low-dose ketamine also has antidepressant and sleep promoting effects. Esketamine is the S-enantiomer of racemic ketamine with a higher affinity for NMDA receptors and is approximately twice as potent as racemic ketamine in analgesia. A recent study showed that dexmedetomidine-esketamine combination improves analgesia without increasing adverse events. After stopping infusion, the analgesic and 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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Refused to participate.
  2. Diagnosed schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis before surgery.
  3. 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.
  4. Diagnosed obstructive sleep apnea (OSA) or judged to be at high-risk of moderate-to-severe OSA before surgery.
  5. 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.
  6. Inability to communicate due to coma, severe dementia, or language barrier before surgery.
  7. Allergy to any drug used during the study, or other conditions that are considered unsuitable for study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine-esketamine combined with oxycodone
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
Dexmedetomidine-esketamine mixture will be infused with doses adjusted to maintain a Richmond Agitation-Sedation Scale between -2 to -1 during surgery.
Drug: Oxycodone
Oxycodone will be injected intravenously 10-15 min before puncture.
Active Comparator: Remifentanil combined with oxycodone
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: Oxycodone
Oxycodone will be injected intravenously 10-15 min before puncture.
Drug: Remifentanil
Remifentanil will be infused with doses adjusted to maintain a Richmond Agitation-Sedation Scale between -2 to -1 during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under curve of Numerical Rating Scale of pain during and within 24 hours after surgery.
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The highest Numerical Rating Scale of pain during surgery.
Time Frame: During 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 2 minutes during radiofrequency-ablation, end of radiofrequency-ablation, and 10 minutes after needle removal during surgery
During surgery.
Number of intraoperative adjustment of study drug infusion rate.
Time Frame: During surgery.
Number of adjustment of study drug infusion rate during surgery.
During surgery.
Pain intensity and opioid consumption (PIOC) index during and within 24 hours after surgery.
Time Frame: During and within 24 hours after surgery.
Pain intensity will be calculated as area under curve (AUC) of Numerical Rating Scale (NRS, an 11-point scale where 0=no pain and 10=the worst pain) of pain during and within 24 hours after surgery. Opioid consumption (OC) during and within 24 hours after surgery will be calculated after excluding remifentanil administered as study drugs. Pain intensity and opioid consumption (PIOC) index will be calculated as: PIOC=[(AUCmean rank - AUCrank)/AUCmean rank] + [(OCmean rank - OCrank)/OCmean rank]. The range of the sum is -200% to +200%. Values above 0 indicate increased summed AUC and OC compared to the all patients.
During and within 24 hours after surgery.
Numeric Rating Scale of subjective sleep quality on the first and second nights after surgery.
Time Frame: On the first and second nights after surgery.
Numerical Rating Scale (NRS, an 11-point scale where 0=the best sleep and 10=the worst sleep) of sleep quality on the first and second nights after surgery.
On the first and second nights after surgery.
Number of additional oxycodone or other analgesics during and within 24 hours after surgery.
Time Frame: During and within 24 hours after 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.
Time Frame: During and within 24 hours after surgery.
Dose of opioids (excluding remifentanil administered as study drugs) will be converted to intravenous morphine equivalent.
During and within 24 hours after surgery.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay after surgery.
Time Frame: Up to 30 days after surgery.
Length of hospital stay after surgery.
Up to 30 days after surgery.
Patients' evaluation on anesthesia.
Time Frame: Within 30 minutes after surgery.
Patients' evaluation will be performed using the Likert five-point scale: 1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, and 5=very satisfied.
Within 30 minutes after surgery.
Surgeons' evaluation on anesthesia.
Time Frame: Within 30 minutes after surgery.
Surgeons' evaluation will be performed using the Likert five-point scale: 1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, and 5=very satisfied.
Within 30 minutes after surgery.
Postoperative recovery time.
Time Frame: Up to 2 hours after surgery.
Time interval between end of surgery and arrival of general ward.
Up to 2 hours after surgery.
Incidence of postoperative complications during hospital stay.
Time Frame: Up to 30 days after surgery.
Postoperative complications are defined as new-onset conditions after surgery that have adverse effects on postoperative recovery and require therapeutic interventions.
Up to 30 days after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

  • Principal Investigator: Dong-Xin Wang, MD, PhD, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2023

Primary Completion (Actual)

September 26, 2024

Study Completion (Actual)

September 28, 2024

Study Registration Dates

First Submitted

August 12, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-276

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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