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Impact of Suppressing Surgical Stress Reaction on Postoperative Inflammation.

A

AZ Sint-Jan AV

Status

Unknown

Conditions

Postoperative Pain
Inflammation

Treatments

Procedure: major surgery under opioid free anesthesia without regional anesthesia

Study type

Observational

Funder types

Other

Identifiers

NCT04195009
OS impact SSR on SIRS d OFA

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Jan Paul Mulier, MD PhD; Joke Denolf

Data sourced from clinicaltrials.gov

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