Dexmedetomidine-esketamine for Percutaneous Radiofrequency Liver Ablation

Trial Title: Dexmedetomidine-esketamine for Percutaneous Radiofrequency Liver Ablation

NCT ID: NCT06003218

Condition: Liver Cancer
Radiofrequency Ablation
Esketamine
Dexmedetomidine

Conditions: Official terms:
Liver Neoplasms
Dexmedetomidine
Remifentanil
Oxycodone
Esketamine

Conditions: Keywords:
Liver cancer
Radiofrequency ablation
Esketamine
Dexmedetomidine

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: Dexmedetomidine-esketamine combination
Description: Dexmedetomidine-esketamine mixture will be infused with doses adjusted to maintain a Richmond Agitation-Sedation Scale between -2 to -1 during surgery.
Arm group label: Dexmedetomidine-esketamine combined with oxycodone

Intervention type: Drug
Intervention name: Remifentanil
Description: Remifentanil will be infused with doses adjusted to maintain a Richmond Agitation-Sedation Scale between -2 to -1 during surgery.
Arm group label: Remifentanil combined with oxycodone

Intervention type: Drug
Intervention name: Oxycodone
Description: Oxycodone will be injected intravenously 10-15 min before puncture.
Arm group label: Dexmedetomidine-esketamine combined with oxycodone
Arm group label: Remifentanil combined with oxycodone

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.

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 85 Years

Healthy volunteers: No

Locations:

Facility:
Name: Peking University First Hospital

Address:
City: Beijing
Zip: 100034
Country: China

Status: Recruiting

Contact:
Last name: Dong-Xin Wang, MD, PhD

Phone: +861083572784
Email: wangdongxin@hotmail.com

Start date: October 16, 2023

Completion date: August 2024

Lead sponsor:
Agency: Peking University First Hospital
Agency class: Other

Source: Peking University First Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06003218