Impact of Suppressing Surgical Stress Reaction on Postoperative Inflammation.

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04195009
• Other study ID #: OS impact SSR on SIRS d OFA
• Status: Not yet recruiting
• Start date: December 1, 2019
• Est. completion date: December 2021

Study information

• Verified date: December 2019
• Source: AZ Sint-Jan AV
• Contact: Jan Paul Mulier, MD PhD
• Phone: +32486729203
• Email: jan.mulier[@]azsintjan.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Postoperative Pain

Intervention

Procedure:
• major surgery under opioid free anesthesia without regional anesthesia
measuring nociception in every patient but blinded for attending anesthesiologist

Locations

Country	Name	City	State
Belgium	Azsintjan	Brugge

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRP 24 hours postoperative	measure chronic reactive protein (CRP) biomarker of surgical inflammation	24 hours postoperative
Secondary	hemodynamic stability	dosis of vasoactive drugs needed to support blood pressure before blood pressure rise as requested by surgeons.	intraoperative
Secondary	postoperative pain using VAS score	postoperative pain measured by visual analog scale (VAS) score: max pain =10 and worst, no pain = 0	up to 4 hours postoperative during post anesthetic care unit (PACU) stay
Secondary	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
Secondary	postoperative opioids used	total amount of opioids needed postoperative	first 24 hours postoperative