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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| major surgery under opioid free anesthesia without regional anesthesia | Procedure | measuring nociception in every patient but blinded for attending anesthesiologist |
| Measure | Description | Time Frame |
|---|---|---|
| CRP 24 hours postoperative | measure chronic reactive protein (CRP) biomarker of surgical inflammation | 24 hours postoperative |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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major surgical procedures without need for regional anesthesia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Paul Mulier, MD PhD | Contact | +32486729203 | jan.mulier@azsintjan.be | |
| Joke Denolf | Contact | 003250452193 | joke.denolf@azsintjan.be |
| Name | Affiliation | Role |
|---|---|---|
| Jan Paul Mulier, MD PhD | AZ Sint-Jan AV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azsintjan | Bruges | 8000 | Belgium |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| 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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |