An observational study in Inflammation and Postoperative Pain, sponsored by AZ Sint-Jan AV. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-11.
Sponsored by AZ Sint-Jan AV · Observational
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.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's planned enrollment of 100 is close to the median of 95 across 895 observational studies indexed under Inflammation.
Browse Inflammation studies →AZ Sint-Jan AV is the lead sponsor of 58 studies on the registry; 14 are open to participants now.
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major surgical procedures without need for regional anesthesia
Exclusion Criteria:
measuring nociception in every patient but blinded for attending anesthesiologist
CRP 24 hours postoperative
measure chronic reactive protein (CRP) biomarker of surgical inflammation
Time frame: 24 hours postoperative
hemodynamic stability
dosis of vasoactive drugs needed to support blood pressure before blood pressure rise as requested by surgeons.
Time frame: intraoperative
postoperative pain using VAS score
postoperative pain measured by visual analog scale (VAS) score: max pain =10 and worst, no pain = 0
Time frame: 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
Time frame: first 4 hours postoperative during PACU stay
postoperative opioids used
total amount of opioids needed postoperative
Time frame: first 24 hours postoperative
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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AZ Sint-Jan AV