Clinical trial

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

Name
2023-276
Description
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.
Trial arms
Trial start
2023-10-16
Estimated PCD
2024-07-01
Trial end
2024-08-01
Status
Recruiting
Treatment
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.
Arms:
Dexmedetomidine-esketamine combined with oxycodone
Remifentanil
Remifentanil will be infused with doses adjusted to maintain a Richmond Agitation-Sedation Scale between -2 to -1 during surgery.
Arms:
Remifentanil combined with oxycodone
Oxycodone
Oxycodone will be injected intravenously 10-15 min before puncture.
Arms:
Dexmedetomidine-esketamine combined with oxycodone, Remifentanil combined with oxycodone
Size
88
Primary endpoint
Area under curve of Numerical Rating Scale of pain during and within 24 hours after surgery.
During and within 24 hours after surgery.
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 88, 'type': 'ESTIMATED'}}
Updated at
2024-01-03

1 organization

3 products

4 indications

Indication
Liver Cancer
Indication
Esketamine
Indication
Dexmedetomidine
Product
Oxycodone