Impact of Suppressing Surgical Stress Reaction on Postoperative Inflammation.

• Conditions: Postoperative Pain; Inflammation

• Registration Number: NCT04195009
• Lead Sponsor: AZ Sint-Jan AV

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.

Study Timeline

• Status Verified: 2019-12
• Study Start: 2019-12-01
• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2019-12-09
• Last Update Submitted: 2019-12-09
• Study First Posted: 2019-12-11
• Last Update Posted: 2019-12-11
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CRP 24 hours postoperative	24 hours postoperative	measure chronic reactive protein (CRP) biomarker of surgical inflammation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Azsintjan; 🇧🇪 Brugge, Belgium