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临床试验/NCT06003218
NCT06003218已完成不适用

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

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2023年10月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
1
主要终点
Area under curve of Numerical Rating Scale of pain during and within 24 hours after surgery.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Dexmedetomidine-esketamine combination (Drug)

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.

干预措施: Oxycodone (Drug)

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.

干预措施: Remifentanil (Drug)

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.

干预措施: Oxycodone (Drug)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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.)
  • Numeric Rating Scale of subjective sleep quality on the first and second nights after surgery.(On the first and second nights after surgery.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong-Xin Wang

Professor and Chairman, Department of Anesthesiology

Peking University First Hospital

研究点 (1)

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