Impact of Suppressing Surgical Stress Reaction on Postoperative Inflammation.

NCT ID: NCT04195009

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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

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Inflammation Postoperative Pain

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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major surgery under opioid free anesthesia without regional anesthesia

measuring nociception in every patient but blinded for attending anesthesiologist

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AZ Sint-Jan AV

OTHER

Sponsor Role lead

Responsible Party

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Jan Mulier

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Paul Mulier, MD PhD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Jan AV

Locations

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Azsintjan

Bruges, , Belgium

Site Status

Countries

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Belgium

Central Contacts

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Jan Paul Mulier, MD PhD

Role: CONTACT

Phone: +32486729203

Email: [email protected]

Joke Denolf

Role: CONTACT

Phone: 003250452193

Email: [email protected]

Other Identifiers

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OS impact SSR on SIRS d OFA

Identifier Type: -

Identifier Source: org_study_id