Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06003218
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-08-12
Brief Title:
Dexmedetomidine-esketamine for Percutaneous Radiofrequency Liver Ablation
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
Official Title:
Dexmedetomidine-esketamine Combined With Oxycodone for Ultrasound-guided Percutaneous Radiofrequency Ablation in Patients With Liver Cancer a Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 analgesicsleep-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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None