NCT04195009

Impact of Suppressing Surgical Stress Reaction on Postoperative Inflammation.

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: AZ Sint-Jan AV · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflammation
• Postoperative Pain

Interventions

Type	Name	Description
PROCEDURE	major surgery under opioid free anesthesia without regional anesthesia	measuring nociception in every patient but blinded for attending anesthesiologist

Timeline

• Start date: 2019-12-01
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2019-12-11
• Last updated: 2019-12-11

Locations

1 site across 1 country: Belgium