InflammationNCT04195009
Impact of Suppressing Surgical Stress Reaction on Postoperative Inflammation.
An observational study of Inflammation and Postoperative Pain, run by AZ Sint-Jan AV at 1 site in Belgium.
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Postoperative Pain
- What is being tested?
- major surgery under opioid free anesthesia without regional anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2019to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: major surgical procedures without need for regional anesthesia
Who may be able to join
- major surgical procedures without need for regional anesthesia
Who cannot join
- allergy to one of the anesthetics used
- major liver, renal cardiac or pulmonary disease reducing normal function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- major surgery under opioid free anesthesia without regional anesthesia
- Medical subject headings
- Inflammation, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
major surgery under opioid free anesthesia without regional anesthesiaProcedure or surgery
measuring nociception in every patient but blinded for attending anesthesiologist
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP 24 hours postoperative
measure chronic reactive protein (CRP) biomarker of surgical inflammation
Measured: 24 hours postoperative
Secondary outcomes (4)
hemodynamic stability
dosis of vasoactive drugs needed to support blood pressure before blood pressure rise as requested by surgeons.
Measured: intraoperative
postoperative pain using VAS score
postoperative pain measured by visual analog scale (VAS) score: max pain =10 and worst, no pain = 0
Measured: 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
Measured: first 4 hours postoperative during PACU stay
postoperative opioids used
total amount of opioids needed postoperative
Measured: first 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Dec 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Mulier, AZ Sint-Jan AV
- Investigators
- Jan Paul Mulier, MD PhD, Principal investigator, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195009
- Sponsor's protocol ID
- OS impact SSR on SIRS d OFA
- Status last verified
- Dec 2019
- First submitted
- 2 Dec 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Evaluating the Impact of Surgical Stress Suppression During Opioid Free Anesthesia on Postoperative Inflammation During Major Surgery.
- ClinicalTrials.gov ID
- NCT04195009
- Acronym / sponsor ID
- OS impact SSR on SIRS d OFA
- Conditions
- Inflammation, Postoperative Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- major surgical procedures without need for regional anesthesia
Key inclusion criteria (1 listed)
- major surgical procedures without need for regional anesthesia
Key exclusion criteria (2 listed)
- allergy to one of the anesthetics used
- major liver, renal cardiac or pulmonary disease reducing normal function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| major surgery under opioid free anesthesia without regional anesthesiameasuring nociception in every patient but blinded for attending anesthesiologist | Procedure or surgery | – |
Primary outcome
CRP 24 hours postoperative
Time frame: 24 hours postoperative
measure chronic reactive protein (CRP) biomarker of surgical inflammation
4 secondary outcomes
hemodynamic stability
Time frame: intraoperative
postoperative pain using VAS score
Time frame: 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
postoperative opioids used
Time frame: first 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Inflammation
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Paul Mulier, MD PhD principal investigator
AZ Sint-Jan AV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Postoperative Pain, run by AZ Sint-Jan AV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Paul Mulier, MD PhD (+32486729203, jan.mulier@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRP 24 hours postoperative (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.