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.
Patient Consent
Age between 40 and 85 years old
Patients undergoing Elective Open Abdominal Aortic Infrarenal Aneurysm Repair
Immunocompromised patients
Patients with active infection
Reoperation on the aorta
Inflammatory bowel Disease
Parallel
Opioid-Based Anesthesia-Analgesia Strategy
DrugA perioperative Opioid-Based multimodal Anesthesia-Analgesia strategy will be implemented as described in the Opioid-Based arm of the study.
Opioid-free Anesthesia-Analgesia Strategy
DrugA perioperative Opioid-Free multimodal Anesthesia-Analgesia strategy will be implemented as described in the Opioid-Free arm of the study.
Surgical Stress Response - IL-6 - Preoperatively
Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - IL-6 - 15 minutes after aortic cross-clamp
Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - IL-6 - 60 minutes after aortic cross-clamp
Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
Surgical Stress Response - IL-6 - 24 hours after aortic cross-clamp release
Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups.
Postoperative pain - Numerical Rating Scale (NRS) - Immediately Postoperatively
Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Postoperative pain - Numerical Rating Scale (NRS) - First postoperative day
Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Postoperative pain - Numerical Rating Scale (NRS) - Second postoperative day
Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Postoperative pain - Numerical Rating Scale (NRS) - Third postoperative day
Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Haemodynamic Stability - Coefficient of Variation PR
Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Coefficient of variation of the PR values will be reported for each patient, extracted from the collected data.
Haemodynamic Stability - Average Real Variability PR
Haemodynamic Stability as quantified by hemodynamic markers, specifically Average Real Variability of the PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Values will be averaged every minute and the Average Real Variability will be reported for each patient, extracted from the collected data.
Haemodynamic Stability - Coefficient of Variation SBP
Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Coefficient of variation of SBP values will be reported for each patient, extracted from the collected data.
Haemodynamic Stability - Average Real Variability SBP
Haemodynamic Stability as quantified by hemodynamic markers, specifically Average Real Variability of the SBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Values will be averaged every minute and the Average Real Variability will be reported for each patient, extracted from the collected data.
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University of Crete
Lead sponsor
University Hospital of Crete
Collaborator
