None listed
Conditions
Interventions
Drug : Study group: VVZ-149 Injection is mixed in normal saline and administered as an intravenous drip according to the prescribed dosing regimen (VVZ-149 820 mg in 410 mL
loading dose 160 mg for 30 minutes + maintenance dose 660 mg for 7.5 hours) immediately prior to anaesthesia and continued intravenously for a total of 8 hours postoperatively.
Placebo control group:
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria are eligible to participate in the study 1. Voluntarily sign an informed consent form before participating in the study, understand the purpose and procedures of the study, and are able to communicate clearly with the investigator. 2. Men and women aged 19 years or older. 3. For women, not pregnant or breastfeeding. 4. Undergoing pre-planned colectomy surgery. 5. American Society of Anesthesiologist (ASA) risk class I or II.
Exclusion criteria
Exclusion criteria: Subjects with any of the following criteria will be excluded from the study. [Surgical factors] 1. Emergency or Unplanned surgery 2. Reoperation for the same condition or reoperation for laparoscopic visceral resection. 3. Pain in the surgical site and surrounding area since before surgery. [Characteristics of the subject] 4. Women who are pregnant or breastfeeding 5. Diagnosed with chronic pain (e.g., persistent pain of NRS 5 or greater at baseline) 6. Subjects with unstable or poorly controlled psychiatric illness (e.g., post-traumatic stress disorder [PTSD], anxiety disorder, depression). However, subjects on stable doses of antidepressants and anti-anxiety medications for at least 60 days prior to screening or subjects on surgery-related anti-anxiety medications will be eligible. 7. Subjects with unstable medical conditions (e.g., unstable angina pectoris, congestive heart failure, renal failure, hepatic insufficiency, acquired immunodeficiency syndrome). 8. Electrocardiographic measurements of QRS >200 msec or QTcF >450 msec (men) or QTcF >470 msec (women) at screening and preoperative evaluation. 9. Body weight less than 50 kg. [Drug, alcohol, and pharmacological considerations] 10. History of alcohol, opiate, or other drug abuse or dependence within 12 months prior to screening (according to DSM-5 criteria). 11. Current or recent (within 30 days prior to surgery) use of opioids, antipsychotic medications. 12. History of opioid tolerance based on questionnaire or clinician judgement. 13. Consumption of alcohol within 24 hours prior to surgery. 14. Use of non-narcotic analgesics or non-steroidal anti-inflammatory drugs (NSAIDs) (including COX-2 inhibitors) within 24 hours prior to surgery. 15. Use of herbal preparations or nutraceuticals (chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, valerian, etc.) within 7 days before surgery 16. Use of medications known to increase PR or QRS interval (Appendix A) within 24 hours prior to surgery. * Appendix A. Medications Known to Increase PR or QRS Interval - PR Interval Prolongation: Digoxin (Digitek®, Lanoxin®), Donepezil (Aricept®), Naratriptan (Amerge®), Propranolol (Atenolol®, Metoprolol®), Sumatriptan (Imitrex®), Verapamil (®) - QRS Interval Prolongation: Amiodarone, Amitriptyline, Amodiaquine, Amoxapine, Bupivacaine, Bupropion, Carbamazepine, Chloroquine (Aralen®), Citalopram, Desethylamodiaquine, Desipramine, Diltiazem, Diphenhydramine, Dolasetron, Fluoxetine, Imipramine, Lamotrigine, Maprotiline, Mesoridazine, Nortriptyline, Perhexiline, Procaine, Quetiapine (Seroquel®), Quinine, Risperidone, Ropivacaine, Thioridazine, Venlafaxine 17. Use of inhibitors or inducers of CYP3A, or drugs that affect the metabolism of the renal transporters OCT2 and MATE1/2K (Appendix B) within 24 hours prior to surgery. * Appendix B. CYP3A inhibitors or inducers, drugs metabolised by OCT2 and MATE1/2 - CYP3A Inhibitors(Weak): chlorzoxazone, cilostazol, fosaprepitant, istradefylline, ivacaftor, lomitapide, ranitidine, ranolazine, tacrolimus, ticagrelor - CYP3A Inhibitors(Moderate): aprepitant, cimetidine, ciprofloxacin, clotrimazole, crizotinib, cyclosporine, dronedarone, erythromycin, fluconazole, fluvoxamine, imatinib, tofisopam, verapamil - CYP3A Inhibitors(Strong): boceprevir, cobicistat, conivaptan, danoprevir and ritonavir, elvitegravir and ritonavir, grapefruit juice, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritona
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the pain intensity curve at 8 hours postoperatively (AUC 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| The amount and number of PCA and rescue medication requests and consumption were measured every 2 hours for 12 hours postoperatively;0h pain intensity reported on awakening from anaesthesia after surgery;The number of requests for rescue medications at 6-46 h postoperatively | — |
Countries
Korea, Republic of
Contacts
Public ContactSang-Wook Lee
Asan Medical Center
Outcome results
None listed