Impact of Suppressing Surgical Stress Reaction on Postoperative Inflammation.

December 9, 2019 updated by: Jan Mulier, AZ Sint-Jan AV

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • Azsintjan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

major surgical procedures without need for regional anesthesia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CRP 24 hours postoperative
Time Frame: 24 hours postoperative
measure chronic reactive protein (CRP) biomarker of surgical inflammation
24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemodynamic stability
Time Frame: intraoperative
dosis of vasoactive drugs needed to support blood pressure before blood pressure rise as requested by surgeons.
intraoperative
postoperative pain using VAS score
Time Frame: 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
up to 4 hours postoperative during post anesthetic care unit (PACU) stay
postoperative sedation using Ramsay score
Time Frame: 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
first 4 hours postoperative during PACU stay
postoperative opioids used
Time Frame: first 24 hours postoperative
total amount of opioids needed postoperative
first 24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AZ Sint-Jan AV

Investigators

  • Principal Investigator: Jan Paul Mulier, MD PhD, AZ Sint-Jan AV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

December 2, 2019

First Submitted That Met QC Criteria

December 9, 2019

First Posted (Actual)

December 11, 2019

Study Record Updates

Last Update Posted (Actual)

December 11, 2019

Last Update Submitted That Met QC Criteria

December 9, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OS impact SSR on SIRS d OFA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammation

Clinical Trials on major surgery under opioid free anesthesia without regional anesthesia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe