Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04791059
Study type Interventional
Source Peking University First Hospital
Contact
Status Completed
Phase Phase 4
Start date April 9, 2021
Completion date October 7, 2022

See also
  Status Clinical Trial Phase
Completed NCT04577430 - Effects of Dexmedetomidine on Cardiac Electrophysiology in Patients Under General Anesthesia During Perioperative Period N/A
Completed NCT03220880 - Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures
Completed NCT05291364 - Dexmedetomidine in Splanchnic Nerve Neurolysis N/A
Recruiting NCT05249153 - Dexmedetomidine and Sufentanil Effect in PCA on Pediatric Patients Undergoing Scoliosis Surgery N/A
Completed NCT01688648 - Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft N/A
Completed NCT05103735 - Propofol-remifentanyl Versus Dexmedetomidine in Awake Craniotomy: Impact on Electroclinical Seizure Activity
Recruiting NCT06030804 - Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery N/A
Terminated NCT03253224 - Magnesium and Postoperative Pain Phase 4
Recruiting NCT06210061 - Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring N/A
Recruiting NCT05525819 - Intrathecal Versus Intravenous Dexmedetomidine in Prostate Transurethral Resection N/A
Completed NCT04665453 - Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children N/A
Completed NCT06018948 - Effect of Two Different Doses of Dexmedetomidine Infusion in Morbidly Obese Patients Phase 4
Completed NCT03775655 - Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section Phase 2/Phase 3
Completed NCT03658421 - Dexmedetomidine as Adjuvant for FNB in TKA N/A
Completed NCT03234660 - Dexmedetomidine and Neuroprotection in Children Undergoing General Anesthesia N/A
Completed NCT06020781 - Efficacy and Safety of Dexmedetomidine to Bupivacaine in Supraclavicular Brachial Plexus Block N/A
Recruiting NCT06207331 - Effects of Atomized Dexmedetomidine on Lung Function in Patients With Chronic Obstructive Pulmonary Disease N/A
Active, not recruiting NCT03629262 - Dexmedetomidine Supplemented Intravenous Analgesia in Elderly After Orthopedic Surgery Phase 4
Completed NCT06098209 - Dexmedetomidine and Propofol in Mechanically Ventilated Patients by Using Salivary Alpha-amylase as a Stress Marker N/A
Not yet recruiting NCT06062550 - Different Dose Esketamine and Dexmedetomidine Combination for Supplemental Analgesia After Scoliosis Correction Surgery Phase 4