Impact of Suppressing Surgical Stress Reaction on Postoperative Inflammation.

Study Overview
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Brief Summary
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Patients undergoing surgery under opioid free general anesthesia (OFA) are monitored with antinociceptive devices like NOL or ANI that measures sympathetic activity but are invisible for the attending anesthesiologist . Observational study comparing patients with sufficient suppression of sympathetic reactions with patients having insufficient suppression on hemodynamic stability, post operative sedation, pain and inflammatory markers.

Detailed Description
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all patients get an opioid free anesthesia using dexmedetomidine, lidocaine, ketamine and magnesium. dosing is according to the attending anesthesiologist. total dose of each drug and duration of anesthesia are recorded. Antinociceptive devices measures how long the patient is during anesthesia having a nociceptive level nociception level index (NOL) or Analgesia Nociception Index (ANI) above normal without showing the data to the attending anesthesiologist. Relationship is calculated between on one side the hemodynamic stability, postoperative sedation, pain, postoperative CRP and on the other side the time NOL is above 20 or ANI is below 50.

Official Title
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Observational Study Evaluating the Impact of Surgical Stress Suppression During Opioid Free Anesthesia on Postoperative Inflammation During Major Surgery.

Conditions
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Inflammation, Postoperative Pain

Intervention / Treatment
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* Procedure: major surgery under opioid free anesthesia without regional anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: major surgical procedures without need for regional anesthesia Exclusion Criteria: allergy to one of the anesthetics used major liver, renal cardiac or pulmonary disease reducing normal function

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: major surgery under opioid free anesthesia without regional anesthesia|measuring nociception in every patient but blinded for attending anesthesiologist|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRP 24 hours postoperative | measure chronic reactive protein (CRP) biomarker of surgical inflammation | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic stability | dosis of vasoactive drugs needed to support blood pressure before blood pressure rise as requested by surgeons. | intraoperative | 
| postoperative pain using VAS score | postoperative pain measured by visual analog scale (VAS) score: max pain =10 and worst, no pain = 0 | up to 4 hours postoperative during post anesthetic care unit (PACU) stay | 
| postoperative sedation using Ramsay score | deepest postoperative sedation level measured by the Ramsay score at the PACU full awake or no sedation = 1 deep sleep or anesthesia = 5 and worst | first 4 hours postoperative during PACU stay | 
| postoperative opioids used | total amount of opioids needed postoperative | first 24 hours postoperative |