drugset / Trial / NCT04894864

Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair

NCT04894864

RandomizedParallel-groupDouble-blindBasic science

Summary

Open Abdominal Aortic Aneurysm (AAA) repair is a high-risk surgical procedure accompanied by intense endocrine and metabolic responses to surgical stress, with subsequent activation of the inflammatory cascade, cytokine and acute-phase protein release, and bone marrow activation. There is a proven correlation of surgical stress, which patients undergoing open AAA repair are subjected to, with patient outcome, morbidity/mortality, intensive care unit stay and overall length of stay. Modern general anesthetic techniques have been revised and rely on perioperative multimodal anesthetic and analgesic strategies for improved overall patient outcome. Based on this context of a multimodal anesthetic technique and having taken into consideration the international "opioid-crisis" epidemic, an Opioid Free Anesthesia-Analgesia (OFA-A) strategy started to emerge. It is based on the administration of a variety of anesthetic/analgesic agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects. Our basic hypothesis is that the implementation of a perioperative multimodal OFA-A strategy, involving the administration of pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, dexketoprofen, paracetamol and magnesium sulphate, will lead to attenuation of surgical stress response compared to a conventional Opioid-Based Anesthesia-Analgesia (OBA-A) strategy. Furthermore, the anticipated attenuation of the inflammatory response, is pressumed to be associated with equal or improved analgesia, compared to a perioperative OBA-A technique.

Timeline

Start
2020-10-08
Primary completion
2026-09-01
Completion
2027-09-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clonidine Other / unclassified
Comparator Dexamethasone Small molecule 8 mg
Comparator Dexamethasone Small molecule 16 mg
Comparator Dexmedetomidine Other / unclassified 0.2 ug/kg
Comparator Dexmedetomidine Other / unclassified 0.5 ug/kg
Comparator Dexmedetomidine Other / unclassified 1.2 ug/kg
Comparator Fentanyl Other / unclassified 1 ug/kg
Comparator Fentanyl Other / unclassified 2 ug/kg
Comparator Fentanyl Other / unclassified 50 ug
Comparator Fentanyl Other / unclassified 100 ug
Comparator Ketamine Small molecule 0.3 mg/kg
Comparator Ketamine Small molecule 0.5 mg/kg
Comparator Ketamine Small molecule 1 mg/kg
Comparator Ketamine Small molecule 1.5 mg/kg
Comparator Lidocaine Other / unclassified 0.5 mg/kg
Comparator Lidocaine Other / unclassified 1 mg/kg
Comparator Magnesium Sulfate Other / unclassified 2.5 g
Comparator Magnesium Sulfate Other / unclassified 5 g
Comparator Morphine Other / unclassified 0.1 mg/kg
Comparator Morphine Other / unclassified 0.12 mg/kg
Comparator Pregabalin Small molecule 25 mg
Comparator Pregabalin Small molecule 50 mg
Comparator Pregabalin Small molecule 150 mg
Comparator Remifentanil Small molecule
Comparator Scopolamine Unknown 10 mg
Comparator Acetaminophen Small molecule 1 g
Comparator Cisatracurium Small molecule 0.2 mg/kg
Comparator Desflurane Other / unclassified
Comparator Dexketoprofen Small molecule 50 mg
Comparator Droperidol Small molecule 0.625 mg
Comparator Midazolam Small molecule 0.03 mg/kg
Comparator Midazolam Small molecule 0.05 mg/kg
Comparator Midazolam Small molecule 0.07 mg/kg
Comparator Ondansetron Other / unclassified 4 mg
Comparator Propofol Small molecule 2 mg/kg
Comparator Propofol Small molecule 3 mg/kg
Comparator Rocuronium Other / unclassified 0.6 mg/kg
Comparator Rocuronium Other / unclassified 1.2 mg/kg
Comparator Ropivacaine Other / unclassified 75 mg
Comparator Ropivacaine Other / unclassified 150 mg
Comparator Tramadol Other / unclassified 50 mg
Comparator Tramadol Other / unclassified 100 mg