Inflammation, Postoperative Pain
Conditions
Brief summary
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
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.
Interventions
PROCEDUREmajor surgery under opioid free anesthesia without regional anesthesia
measuring nociception in every patient but blinded for attending anesthesiologist
Sponsors
AZ Sint-Jan AV
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRP 24 hours postoperative | 24 hours postoperative | measure chronic reactive protein (CRP) biomarker of surgical inflammation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hemodynamic stability | intraoperative | dosis of vasoactive drugs needed to support blood pressure before blood pressure rise as requested by surgeons. |
| postoperative pain using VAS score | up to 4 hours postoperative during post anesthetic care unit (PACU) stay | postoperative pain measured by visual analog scale (VAS) score: max pain =10 and worst, no pain = 0 |
| postoperative sedation using Ramsay score | first 4 hours postoperative during PACU stay | 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 |
| postoperative opioids used | first 24 hours postoperative | total amount of opioids needed postoperative |
Countries
Belgium
Contacts
Primary ContactJan Paul Mulier, MD PhD
Backup ContactJoke Denolf
Outcome results
None listed