RecruitingPhase 4

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

NCT04894864 · University of Crete

Recruiting

Status

Accepting participants

Phase 4

Phase

Target enrolment

Study sites

Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Surgical Stress Response - IL-6 - Preoperatively
Measured over 1) Preoperatively (as a baseline)
Surgical Stress Response - IL-6 - 15 minutes after aortic cross-clamp
Measured over 2) 15 minutes after aortic cross-clamping
Surgical Stress Response - IL-6 - 60 minutes after aortic cross-clamp
Measured over 3) 60 minutes after aortic cross-clamp release
Surgical Stress Response - IL-6 - 24 hours after aortic cross-clamp release
Measured over 4) 24 hours after aortic cross-clamp release
Surgical Stress Response - IL-8 - Preoperatively
Measured over 1) Preoperatively (as a baseline)
Surgical Stress Response - IL-8 - 15 minutes after aortic cross-clamp
Measured over 2) 15 minutes after aortic cross-clamping
Surgical Stress Response - IL-8 - 60 minutes after aortic cross-clamp
Measured over 3) 60 minutes after aortic cross-clamp release
Surgical Stress Response - IL-8 - 24 hours after aortic cross-clamp release
Measured over 4) 24 hours after aortic cross-clamp release
Surgical Stress Response - IL-10 - Preoperatively
Measured over 1) Preoperatively (as a baseline)
Surgical Stress Response - IL-10 - 15 minutes after aortic cross-clamp
Measured over 2) 15 minutes after aortic cross-clamping
Surgical Stress Response - IL-10 - 60 minutes after aortic cross-clamp
Measured over 3) 60 minutes after aortic cross-clamp release
Surgical Stress Response - IL-10 - 24 hours after aortic cross-clamp release
Measured over 4) 24 hours after aortic cross-clamp release
Surgical Stress Response - Copeptin - Preoperatively
Measured over 1) Preoperatively (as a baseline)
Surgical Stress Response - Copeptin - 15 minutes after aortic cross-clamp
Measured over 2) 15 minutes after aortic cross-clamping
Surgical Stress Response - Copeptin - 60 minutes after aortic cross-clamp
Measured over 3) 60 minutes after aortic cross-clamp release
Surgical Stress Response - Copeptin - 24 hours after aortic cross-clamp release
Measured over 4) 24 hours after aortic cross-clamp release
Surgical Stress Response - TNF-a - Preoperatively
Measured over 1) Preoperatively (as a baseline)
Surgical Stress Response - TNF-a - 15 minutes after aortic cross-clamp
Measured over 2) 15 minutes after aortic cross-clamping
Surgical Stress Response - TNF-a - 60 minutes after aortic cross-clamp
Measured over 3) 60 minutes after aortic cross-clamp release
Surgical Stress Response - TNF-a - 24 hours after aortic cross-clamp release
Measured over 4) 24 hours after aortic cross-clamp release
Surgical Stress Response - Cortisol - Preoperatively
Measured over 1) Preoperatively (as a baseline)
Surgical Stress Response - Cortisol - 15 minutes after aortic cross-clamp
Measured over 2) 15 minutes after aortic cross-clamping
Surgical Stress Response - Cortisol - 60 minutes after aortic cross-clamp
Measured over 3) 60 minutes after aortic cross-clamp release
Surgical Stress Response - Cortisol - 24 hours after aortic cross-clamp release
Measured over 4) 24 hours after aortic cross-clamp release
Surgical Stress Response - CRP - Preoperatively
Measured over 1) Preoperatively (as a baseline)
Surgical Stress Response - CRP - 15 minutes after aortic cross-clamp
Measured over 2) 15 minutes after aortic cross-clamping
Surgical Stress Response - CRP - 60 minutes after aortic cross-clamp
Measured over 3) 60 minutes after aortic cross-clamp release
Surgical Stress Response - CRP - 24 hours after aortic cross-clamp release
Measured over 4) 24 hours after aortic cross-clamp release
Surgical Stress Response - WBC - Preoperatively
Measured over 1) Preoperatively (as a baseline)
Surgical Stress Response - WBC - 15 minutes after aortic cross-clamp
Measured over 2) 15 minutes after aortic cross-clamping
Surgical Stress Response - WBC - 60 minutes after aortic cross-clamp
Measured over 3) 60 minutes after aortic cross-clamp release
Surgical Stress Response - WBC - 24 hours after aortic cross-clamp release
Measured over 4) 24 hours after aortic cross-clamp release
Haemodynamic Stability - Tachycardia
Measured over From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Bradycardia
Measured over From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Hypotension SBP
Measured over Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Hypotension MBP
Measured over Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Hypertension
Measured over Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Fluid requirements - Crystalloids - Intraoperatively
Measured over From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Fluid requirements - Crystalloids - 24 hours postoperatively
Measured over From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Fluid requirements - Colloids - Intraoperatively
Measured over From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Fluid requirements - Colloids - 24 hours postoperatively
Measured over From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Fluid requirements - Concentrated RBCs - Intraoperatively
Measured over From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Fluid requirements - Concentrated RBCs - 24 hours postoperatively
Measured over From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Fluid requirements - Plasma - Intraoperatively
Measured over From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Fluid requirements - Plasma - 24 hours postoperatively
Measured over From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Fluid requirements - Platelets - Intraoperatively
Measured over From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Fluid requirements - Platelets - 24 hours postoperatively
Measured over From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Blood Loss - Intraoperatively
Measured over From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Blood Loss - 24 hours postoperatively
Measured over From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Fluid Balance - Intraoperatively
Measured over From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Fluid Balance - 24 hours postoperatively
Measured over From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Vasoactive Requirements - Adrenaline - Intraoperatively
Measured over From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Vasoactive Requirements - Adrenaline - 24 hours postoperatively
Measured over From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - Intraoperatively
Measured over From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - 24 hours postoperatively
Measured over From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Vasoactive Requirements - Ephedrine - Intraoperatively
Measured over From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Vasoactive Requirements - Ephedrine - 24 hours postoperatively
Measured over From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - Intraoperatively
Measured over From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - 24 hours postoperatively
Measured over From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Vasoactive Requirements - Dobutamine - Intraoperatively
Measured over From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Vasoactive Requirements - Dobutamine - 24 hours postoperatively
Measured over From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Vasoactive Requirements - Dopamine - Intraoperatively
Measured over From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Vasoactive Requirements - Dopamine - 24 hours postoperatively
Measured over From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - Intraoperatively
Measured over From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - 24 hours postoperatively
Measured over From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

40 Years to 85 Years

Ages

All

Sex

Not accepted

Healthy volunteers

Inclusion Criteria: 1. Patient Consent 2. Age between 40 and 85 years old 3. Patients undergoing Elective Open Abdominal Aortic Infrarenal Aneurysm Repair Exclusion Criteria: 1. Immunocompromised patients 2. Patients with active infection 3. Reoperation on the aorta 4. Inflammatory bowel Disease 5. Malignancy 6. Chronic Inflammatory conditions (e.g. Rheymatoid arthritis, Psoriatic arthritis) 7. Chronic corticosteroid or immunosuppressive drug use 8. Intraoperative transfusion with \>2 units of packed Red Blood Cells

Where

1 study site

Facility	City	Region	Country
University of Crete	Heraklion	Crete	Greece

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04894864 on ClinicalTrials.gov →

Last updated in the registry 2026-06-16. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Ketamine

Indication