Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04791059
Status:
COMPLETED
Last Update Posted:
2022-12-13
First Post:
2021-03-08
Brief Title:
Low-dose S-ketamine and Dexmedetomidine in Combination With Opioids for Postoperative Analgesia
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
Official Title:
Low-dose S-ketamine and Dexmedetomidine in Combination With Opioids for Patient-controlled Analgesia After Scoliosis Correction Surgery a Randomized Double-blind Placebo-controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-12
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:
Scoliosis correction surgery is followed with severe pain Patients after scoliosis correction surgery usually require high dose opioids and long duration analgesia which may increase side effects and even drug tolerance S-ketamine is the pure dextrorotatory enantiomer of ketamine with stronger analgesic effect and less side effects but mental side effects is a major concern Dexmedetomidine can be used as an analgesic supplement it also improves sleep quality in postoperative patients We hypothesize that low-dose ketamine and dexmedetomidine in combination with opioids may have synergistic effect in analgesia and reduce drug-related side effects This study aims to explore the effect of low-dose of S-ketamine and dexmedetomidine in combination with opioids for postoperative patient-controlled intravenous analgesia in patients following scoliosis correction surgery
Detailed Description:
Scoliosis correction surgery is followed with severe pain The reported median pain score on the first day after surgery is median 7 IQR 4 8 with an incidence of persistent postoperative pain from 5 to 75 Most patients undergoing this surgery are young and adolescents they are sensitive to pain and usually require higher dose analgesics and a long duration analgesia The total dose of opioids required for postoperative analgesia is about 2-4 times higher than that after other surgeries But even with high dose opioids the analgesic effect remains unsatisfied Furthermore high dose opioids may cause side effects such as respiratory depression drowsiness nausea vomiting skin itching and even drug tolerance
Ketamine is a noncompetitive N-methyl-D-aspartate receptor antagonist NMDA with analgesic and anti-hyperalgesia effects It is widely used for anesthesia induction in critically ill patients pediatric anesthesia and postoperative analgesia The advantages of ketamine include mild influence on respiratory and circulatory function and good analgesic effect Recent guidelines recommends the use of low-dose ketamine infusion for postoperative analgesia in patients with moderate to severe pain in order to reduce the consumption of opioids S-ketamine is the pure dextrorotatory enantiomer of ketamine with stronger analgesic effect and lower incidence of adverse reactions
Dexmedetomidine is a highly selective α2 receptor agonist with effects of antianxiety sedation and analgesia When used as a supplement it improves analgesic effect and reduces opioid consumption and opioid related adverse reactions In the same time dexmedetomidine activates the endogenous sleep pathway and improves sleep quality by prolonging total sleep time increasing sleep efficiency and promoting subjective sleep quality
It is worthy to note that ketamine can produce adverse reactions such as agitation delirium and anxiety and increase the incidence of hallucinations and nightmares when the given dose is slightly higher whereas the sedative effect of dexmedetomidine may help to reduce the adverse effects of ketamine We hypothesize that low-dose ketamine and dexmedetomidine in combination with opioids may have synergistic effects in postoperative analgesia and reduce drug-related adverse reactions
This study aims to explore the effect of low-dose of S-ketamine and dexmedetomidine in combination with opioids for postoperative patient-controlled intravenous analgesia in patients following scoliosis correction surgery
Ketamine is a noncompetitive N-methyl-D-aspartate receptor antagonist NMDA with analgesic and anti-hyperalgesia effects It is widely used for anesthesia induction in critically ill patients pediatric anesthesia and postoperative analgesia The advantages of ketamine include mild influence on respiratory and circulatory function and good analgesic effect Recent guidelines recommends the use of low-dose ketamine infusion for postoperative analgesia in patients with moderate to severe pain in order to reduce the consumption of opioids S-ketamine is the pure dextrorotatory enantiomer of ketamine with stronger analgesic effect and lower incidence of adverse reactions
Dexmedetomidine is a highly selective α2 receptor agonist with effects of antianxiety sedation and analgesia When used as a supplement it improves analgesic effect and reduces opioid consumption and opioid related adverse reactions In the same time dexmedetomidine activates the endogenous sleep pathway and improves sleep quality by prolonging total sleep time increasing sleep efficiency and promoting subjective sleep quality
It is worthy to note that ketamine can produce adverse reactions such as agitation delirium and anxiety and increase the incidence of hallucinations and nightmares when the given dose is slightly higher whereas the sedative effect of dexmedetomidine may help to reduce the adverse effects of ketamine We hypothesize that low-dose ketamine and dexmedetomidine in combination with opioids may have synergistic effects in postoperative analgesia and reduce drug-related adverse reactions
This study aims to explore the effect of low-dose of S-ketamine and dexmedetomidine in combination with opioids for postoperative patient-controlled intravenous analgesia in patients following scoliosis correction surgery
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