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

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.

Conditions

• Elective Surgical Procedures
• Postoperative Pain
• Anesthesia
• Opioid Use
• Abdominal Aortic Aneurysm Without Rupture
• Vascular Surgical Procedure
• Interleukin 6
• Immunomodulators

Interventions

DRUG

Opioid-Based Anesthesia-Analgesia Strategy

A perioperative Opioid-Based multimodal Anesthesia-Analgesia strategy will be implemented as described in the Opioid-Based arm of the study.

DRUG

Opioid-free Anesthesia-Analgesia Strategy

A perioperative Opioid-Free multimodal Anesthesia-Analgesia strategy will be implemented as described in the Opioid-Free arm of the study.

Sponsors & Collaborators

• University Hospital of Crete

  collaborator OTHER

• University of Crete

  lead OTHER

Principal Investigators

• Vasileia Nyktari, MD,PhD · University of Crete, Medical School

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-08

Primary Completion

2025-10-08

Completion

2027-10-08

Countries

• Greece

Study Locations