Liver CancerNCT06003218
Dexmedetomidine-esketamine for Percutaneous Radiofrequency Liver Ablation
A study testing Dexmedetomidine-esketamine combination, Remifentanil and Oxycodone in people with Liver Cancer and Radiofrequency Ablation, run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Liver Cancer, Radiofrequency Ablation, Esketamine
- What is being tested?
- Dexmedetomidine-esketamine combination, Remifentanil and Oxycodone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2023to 28 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years but ≤85 years.
- Scheduled for elective ultrasound-guided percutaneous radiofrequency ablation for primary or metastatic liver cancer.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Cancer, Radiofrequency Ablation, Esketamine, Dexmedetomidine
- Being tested
- Dexmedetomidine-esketamine combination, Remifentanil, Oxycodone
- Keywords
- Liver cancer, Radiofrequency ablation, Esketamine, Dexmedetomidine
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine-esketamine combinationDrug
Dexmedetomidine-esketamine mixture will be infused with doses adjusted to maintain a Richmond Agitation-Sedation Scale between -2 to -1 during surgery.
RemifentanilDrug
Remifentanil will be infused with doses adjusted to maintain a Richmond Agitation-Sedation Scale between -2 to -1 during surgery.
OxycodoneDrug
Oxycodone will be injected intravenously 10-15 min before puncture.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Remifentanil; Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During and within 24 hours after surgery.
Secondary outcomes (6)
The highest Numerical Rating Scale of pain 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
Measured: During surgery.
Number of intraoperative adjustment of study drug infusion rate.
Number of adjustment of study drug infusion rate during surgery.
Measured: During surgery.
Number of additional oxycodone or other analgesics during and within 24 hours after surgery.
Number of additional oxycodone or other analgesics during and within 24 hours after surgery.
Measured: During and within 24 hours after surgery.
Dose of analgesics during and within 24 hours after surgery.
Dose of opioids (excluding remifentanil administered as study drugs) will be converted to intravenous morphine equivalent.
Measured: During and within 24 hours after surgery.
Pain intensity and opioid consumption (PIOC) index 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.
Measured: During and within 24 hours after surgery.
Numeric Rating Scale of subjective sleep quality 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.
Measured: On the first and second nights after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start16 Oct 2023
- Primary completion26 Sep 2024
- Study completion28 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003218
- Sponsor's protocol ID
- 2023-276
- Status last verified
- Mar 2025
- First submitted
- 12 Aug 2023
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McGahan JP, Browning PD, Brock JM, Tesluk H. Hepatic ablation using radiofrequency electrocautery. Invest Radiol. 1990 Mar;25(3):267-70. doi: 10.1097/00004424-199003000-00011. No abstract available.
PubMed 2185179European Association for Study of Liver; European Organisation for Research and Treatment of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. Eur J Cancer. 2012 Mar;48(5):599-641. doi: 10.1016/j.ejca.2011.12.021. No abstract available.
PubMed 22424278Higgins H, Berger DL. RFA for liver tumors: does it really work? Oncologist. 2006 Jul-Aug;11(7):801-8. doi: 10.1634/theoncologist.11-7-801.
PubMed 16880239Olesen AE, Kristensen K, Staahl C, Kell S, Wong GY, Arendt-Nielsen L, Drewes AM. A population pharmacokinetic and pharmacodynamic study of a peripheral kappa-opioid receptor agonist CR665 and oxycodone. Clin Pharmacokinet. 2013 Feb;52(2):125-37. doi: 10.1007/s40262-012-0023-8.
PubMed 23212610Riviere PJ. Peripheral kappa-opioid agonists for visceral pain. Br J Pharmacol. 2004 Apr;141(8):1331-4. doi: 10.1038/sj.bjp.0705763. Epub 2004 Mar 29.
PubMed 15051626Wang J, Yuan X, Guo W, Xiang X, Wu Q, Fang M, Zhang W, Ding Z, Xie K, Fang J, Zhou H, Fu S. Sedation and Analgesia for Liver Cancer Percutaneous Radiofrequency Ablation: Fentanyl and Oxycodone Comparison. Int J Med Sci. 2020 Aug 12;17(14):2194-2199. doi: 10.7150/ijms.47067. eCollection 2020.
PubMed 32922181Wu WT, Jia ZY, Chen Y, Chen QF, Zu QQ, Yang ZQ, Liu S, Shi HB. The Safety and Efficacy of Oxycodone Versus Fentanyl in Percutaneous Microwave Ablation of a Liver Tumour Abutting the Capsule. Cardiovasc Intervent Radiol. 2019 Jan;42(1):87-94. doi: 10.1007/s00270-018-1980-6. Epub 2018 May 8.
PubMed 29740688Wu J, Lu Y, Cao X. Different effects of oxycodone and remifentanil in patients undergoing ultrasound-guided percutaneous radiofrequency ablation of hepatic cancer: a randomized trial. Drug Des Devel Ther. 2019 Jan 18;13:365-372. doi: 10.2147/DDDT.S188728. eCollection 2019.
PubMed 30705584Yu EH, Tran DH, Lam SW, Irwin MG. Remifentanil tolerance and hyperalgesia: short-term gain, long-term pain? Anaesthesia. 2016 Nov;71(11):1347-1362. doi: 10.1111/anae.13602.
PubMed 27734470Ongiem A, Siriussawakul A, Aungsumat Wangdee BNS W, Homsud S, Jaiyen T. Assessment of Pain Severity after Radiofrequency Ablation in Patients with Hepatocellular Carcinoma. J Med Assoc Thai. 2016 May;99(5):572-7.
PubMed 27501613Nelson LE, Lu J, Guo T, Saper CB, Franks NP, Maze M. The alpha2-adrenoceptor agonist dexmedetomidine converges on an endogenous sleep-promoting pathway to exert its sedative effects. Anesthesiology. 2003 Feb;98(2):428-36. doi: 10.1097/00000542-200302000-00024.
PubMed 12552203Xia ZQ, Chen SQ, Yao X, Xie CB, Wen SH, Liu KX. Clinical benefits of dexmedetomidine versus propofol in adult intensive care unit patients: a meta-analysis of randomized clinical trials. J Surg Res. 2013 Dec;185(2):833-43. doi: 10.1016/j.jss.2013.06.062. Epub 2013 Jul 24.
PubMed 23910886Sun YM, Zhu SN, Zhang C, Li SL, Wang DX. Effect of low-dose dexmedetomidine on sleep quality in postoperative patients with mechanical ventilation in the intensive care unit: A pilot randomized trial. Front Med (Lausanne). 2022 Aug 31;9:931084. doi: 10.3389/fmed.2022.931084. eCollection 2022.
PubMed 36117973Barrett W, Buxhoeveden M, Dhillon S. Ketamine: a versatile tool for anesthesia and analgesia. Curr Opin Anaesthesiol. 2020 Oct;33(5):633-638. doi: 10.1097/ACO.0000000000000916.
PubMed 32826629Kaur U, Pathak BK, Singh A, Chakrabarti SS. Esketamine: a glimmer of hope in treatment-resistant depression. Eur Arch Psychiatry Clin Neurosci. 2021 Apr;271(3):417-429. doi: 10.1007/s00406-019-01084-z. Epub 2019 Nov 19.
PubMed 31745646
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine-esketamine Combined With Oxycodone for Ultrasound-guided Percutaneous Radiofrequency Ablation in Patients With Liver Cancer: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06003218
- Acronym / sponsor ID
- 2023-276
- Conditions
- Liver Cancer, Radiofrequency Ablation, Esketamine, Dexmedetomidine
- Keywords
- Liver cancer, Radiofrequency ablation, Esketamine, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 28 Sep 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine-esketamine combined with oxycodone | Experimental | Drug: Dexmedetomidine-esketamine combination, Drug: OxycodoneDexmedetomidine-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. |
| Remifentanil combined with oxycodone | Active comparator | Drug: Remifentanil, Drug: OxycodoneRemifentanil will be infused in addition to oxycodone; the target is to maintain a Richmond Agitation and Sedation Scale between -2 and -1 during surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged ≥18 years but ≤85 years.
- Scheduled for elective ultrasound-guided percutaneous radiofrequency ablation for primary or metastatic liver cancer.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine-esketamine combinationDexmedetomidine-esketamine mixture will be infused with doses adjusted to maintain a Richmond Agitation-Sedation Scale between -2 to -1 during surgery. | Drug | Dexmedetomidine-esketamine combined with oxycodone |
| RemifentanilRemifentanil will be infused with doses adjusted to maintain a Richmond Agitation-Sedation Scale between -2 to -1 during surgery. | Drug | Remifentanil combined with oxycodone |
| OxycodoneOxycodone will be injected intravenously 10-15 min before puncture. | Drug | Dexmedetomidine-esketamine combined with oxycodone, Remifentanil combined with oxycodone |
Primary outcome
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.
6 secondary outcomes
The highest Numerical Rating Scale of pain during surgery.
Time frame: During surgery.
Number of intraoperative adjustment of study drug infusion rate.
Time frame: During surgery.
Number of additional oxycodone or other analgesics during and within 24 hours after surgery.
Time frame: 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.
Pain intensity and opioid consumption (PIOC) index during and within 24 hours after surgery.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Background: PubMed 2185179McGahan JP, Browning PD, Brock JM, Tesluk H. Hepatic ablation using radiofrequency electrocautery. Invest Radiol. 1990 Mar;25(3):267-70. doi: 10.1097/00004424-199003000-00011. No abstract available.
- Background: PubMed 22424278European Association for Study of Liver; European Organisation for Research and Treatment of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. Eur J Cancer. 2012 Mar;48(5):599-641. doi: 10.1016/j.ejca.2011.12.021. No abstract available.
- Background: PubMed 16880239Higgins H, Berger DL. RFA for liver tumors: does it really work? Oncologist. 2006 Jul-Aug;11(7):801-8. doi: 10.1634/theoncologist.11-7-801.
- Background: PubMed 23212610Olesen AE, Kristensen K, Staahl C, Kell S, Wong GY, Arendt-Nielsen L, Drewes AM. A population pharmacokinetic and pharmacodynamic study of a peripheral kappa-opioid receptor agonist CR665 and oxycodone. Clin Pharmacokinet. 2013 Feb;52(2):125-37. doi: 10.1007/s40262-012-0023-8.
- Background: PubMed 15051626Riviere PJ. Peripheral kappa-opioid agonists for visceral pain. Br J Pharmacol. 2004 Apr;141(8):1331-4. doi: 10.1038/sj.bjp.0705763. Epub 2004 Mar 29.
- Background: PubMed 32922181Wang J, Yuan X, Guo W, Xiang X, Wu Q, Fang M, Zhang W, Ding Z, Xie K, Fang J, Zhou H, Fu S. Sedation and Analgesia for Liver Cancer Percutaneous Radiofrequency Ablation: Fentanyl and Oxycodone Comparison. Int J Med Sci. 2020 Aug 12;17(14):2194-2199. doi: 10.7150/ijms.47067. eCollection 2020.
- Background: PubMed 29740688Wu WT, Jia ZY, Chen Y, Chen QF, Zu QQ, Yang ZQ, Liu S, Shi HB. The Safety and Efficacy of Oxycodone Versus Fentanyl in Percutaneous Microwave Ablation of a Liver Tumour Abutting the Capsule. Cardiovasc Intervent Radiol. 2019 Jan;42(1):87-94. doi: 10.1007/s00270-018-1980-6. Epub 2018 May 8.
- Background: PubMed 30705584Wu J, Lu Y, Cao X. Different effects of oxycodone and remifentanil in patients undergoing ultrasound-guided percutaneous radiofrequency ablation of hepatic cancer: a randomized trial. Drug Des Devel Ther. 2019 Jan 18;13:365-372. doi: 10.2147/DDDT.S188728. eCollection 2019.
- Background: PubMed 27734470Yu EH, Tran DH, Lam SW, Irwin MG. Remifentanil tolerance and hyperalgesia: short-term gain, long-term pain? Anaesthesia. 2016 Nov;71(11):1347-1362. doi: 10.1111/anae.13602.
- Background: PubMed 27501613Ongiem A, Siriussawakul A, Aungsumat Wangdee BNS W, Homsud S, Jaiyen T. Assessment of Pain Severity after Radiofrequency Ablation in Patients with Hepatocellular Carcinoma. J Med Assoc Thai. 2016 May;99(5):572-7.
- Background: PubMed 12552203Nelson LE, Lu J, Guo T, Saper CB, Franks NP, Maze M. The alpha2-adrenoceptor agonist dexmedetomidine converges on an endogenous sleep-promoting pathway to exert its sedative effects. Anesthesiology. 2003 Feb;98(2):428-36. doi: 10.1097/00000542-200302000-00024.
- Background: PubMed 23910886Xia ZQ, Chen SQ, Yao X, Xie CB, Wen SH, Liu KX. Clinical benefits of dexmedetomidine versus propofol in adult intensive care unit patients: a meta-analysis of randomized clinical trials. J Surg Res. 2013 Dec;185(2):833-43. doi: 10.1016/j.jss.2013.06.062. Epub 2013 Jul 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong-Xin Wang, MD, PhD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine-esketamine combination, Remifentanil and Oxycodone in people with Liver Cancer and Radiofrequency Ablation, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06003218, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.