Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04894864
Status:
RECRUITING
Last Update Posted:
2024-01-08
First Post:
2021-04-19
Brief Title:
Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair
Sponsor:
University of Crete
Organization:
University of Crete
Study Overview
Official Title:
Effect of a Perioperative Opioid Free Anesthesia-Analgesia OFA-A Strategy on Surgical Stress Response in Elective Open Abdominal Aortic Aneurysm Repair A Prospective Randomized Study
Status:
RECRUITING
Status Verified Date:
2024-10
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:
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 morbiditymortality 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 anestheticanalgesic 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
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
Detailed Description:
Open abdominal aortic aneurysm AAA repair surgery is a high-risk operation often performed on high-risk patients Despite advancements made in diagnosis management surgical techniques and treatment of these patients morbidity and mortality remain high Mortality after open AAA repair remains higher than the average mortality of the matched population for age and sex Debate is ongoing as to whether open AAA repair or endovascular aneurysm repair EVAR is better in terms of overall long-term survival rate
Regarding open AAA repair the very nature of the surgery itself with surgical trauma aortic cross clamping and its resulting ischemia-reperfusion injury and cellular interactions of blood with the biomaterial surface of the graft causes intense and varied metabolic endocrine and immunological responses These surgical stress-related responses are evident as marked increases in inflammatory cytokines such as TNF-a IL-1a IL-6 IL-8 IL-10 stimulation of the sympathetic system and stimulation of the hypothalamic-pituitary-adrenal axis caused by release of CRH and AVP High levels of IL-6 peaking at 4-48h after clamp removal have been associated with serious postoperative complications and its levels reflect the intensity of surgical trauma following AAA repair Other inflammation markers such as CRP and leukocytes have also been shown to increase postoperatively
While the surgical technique has been extensively studied as to the role it plays on the control of the surgical stress response patient outcome morbidity and overall mortality fewer studies have been conducted to study the effect of the anesthetic management on these factors While most of them have been focusing on the comparison of general anesthetic vs regional techniques only few compare different general anesthetic techniques on patient outcome
Modern general anesthetic techniques have been revised and rely on a multimodal anesthetic and analgesic perioperative regimen for improved patient outcome A multimodal regimen requires the administration of at least 2 factors with different mechanisms of action At least one factor causes inhibition of central sensitization and at least another one inhibits the peripheral sensitization of the nervous system as a response to painful surgical stimuli mitigating adverse neuroplasticity One such example is an Opioid-Free Anesthetic-Analgesic OFA-A strategy which implements a variety of pharmacological agents including some with demonstrated immunomodulating and anti-inflammatory effects Apart from sparing any opioid-related adverse effects an OFA-A multimodal strategy targets optimal analgesia with a multitude of factors in the lowest possible dose aiming for additive or synergistic effects An additional advantage of using an OFA-A technique is the prevention of opioid-induced hyperalgesia
Our hypothesis is that implementation of a multimodal OFA-A strategy leads to a decreased sympathetic and inflammatory response compared to conventional opioid-based anesthetic techniques A decreased inflammatory and stress response as expressed by reduced levels of IL-6 IL-8 IL-10 TNF-a CRP cortisol arginine vasopressin AVP white blood cells count and hemodynamic stability is expected to decrease peripheral and central sensitization contributing to better postoperative analgesia
Regarding open AAA repair the very nature of the surgery itself with surgical trauma aortic cross clamping and its resulting ischemia-reperfusion injury and cellular interactions of blood with the biomaterial surface of the graft causes intense and varied metabolic endocrine and immunological responses These surgical stress-related responses are evident as marked increases in inflammatory cytokines such as TNF-a IL-1a IL-6 IL-8 IL-10 stimulation of the sympathetic system and stimulation of the hypothalamic-pituitary-adrenal axis caused by release of CRH and AVP High levels of IL-6 peaking at 4-48h after clamp removal have been associated with serious postoperative complications and its levels reflect the intensity of surgical trauma following AAA repair Other inflammation markers such as CRP and leukocytes have also been shown to increase postoperatively
While the surgical technique has been extensively studied as to the role it plays on the control of the surgical stress response patient outcome morbidity and overall mortality fewer studies have been conducted to study the effect of the anesthetic management on these factors While most of them have been focusing on the comparison of general anesthetic vs regional techniques only few compare different general anesthetic techniques on patient outcome
Modern general anesthetic techniques have been revised and rely on a multimodal anesthetic and analgesic perioperative regimen for improved patient outcome A multimodal regimen requires the administration of at least 2 factors with different mechanisms of action At least one factor causes inhibition of central sensitization and at least another one inhibits the peripheral sensitization of the nervous system as a response to painful surgical stimuli mitigating adverse neuroplasticity One such example is an Opioid-Free Anesthetic-Analgesic OFA-A strategy which implements a variety of pharmacological agents including some with demonstrated immunomodulating and anti-inflammatory effects Apart from sparing any opioid-related adverse effects an OFA-A multimodal strategy targets optimal analgesia with a multitude of factors in the lowest possible dose aiming for additive or synergistic effects An additional advantage of using an OFA-A technique is the prevention of opioid-induced hyperalgesia
Our hypothesis is that implementation of a multimodal OFA-A strategy leads to a decreased sympathetic and inflammatory response compared to conventional opioid-based anesthetic techniques A decreased inflammatory and stress response as expressed by reduced levels of IL-6 IL-8 IL-10 TNF-a CRP cortisol arginine vasopressin AVP white blood cells count and hemodynamic stability is expected to decrease peripheral and central sensitization contributing to better postoperative analgesia
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?:
True
Is an FDA AA801 Violation?:
None