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Evaluation of the Early Use of Norepinephrine in Major Abdominal Surgery on Postoperative Organ Dysfunction

Recruiting
18 years of age
Both
Phase 3

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Overview

Hemodynamic instability is frequent during surgery and intraoperative hypotension is associated with excess morbidity and excess mortality in high-risk patients. In major abdominal surgery the incidence of intraoperative hypotension remains high.

For the past few years, some teams have proposed evaluating norepinephrine as a first-line drug in the presence of hypotension or even before hypotension occurs Thus in obstetrics, the preventive use of norepinephrine for cesareans performed under spinal anesthesia was associated with a reduction in the incidence of hypotension per operative without deleterious effect for the newborn or parturient. In the absence of any observed complications, several teams began to use noradrenaline prophylactically in other surgery. However, no study has demonstrated its benefit, particularly the term of surgical complication in abdominal surgery. The objective of this work is to assess the preventive use of norepinephrine in major abdominal surgery on the occurrence of intraoperative hypotension, postoperative organ dysfunction and postoperative medical and surgical complications.

Eligibility

Inclusion Criteria:

  • Patients scheduled for major abdominal surgery (defined as surgery with a risk of cardiovascular complications of >1% and/or lasting more than 2 hours) with general anaesthesia.
  • American Society of Anesthesiologists physical status (ASA-PS) score of ≥2.
  • Age of ≥50 years and weighing more than 50 kg
  • Written informed consent.

Exclusion Criteria:

  • Emergency surgery.
  • Untreated or uncontrolled hypertension (systolic blood pressure of >150 mm Hg), despite medication.
  • Any acute cardiovascular event, including acute or decompensated heart failure or acute coronary syndrome.
  • Patients with chronic kidney disease with a glomerular filtration rate of <30 ml.min-1/1.73 m2 or requiring renal replacement therapy for end-stage renal disease.
  • Patients with severe hepatic failure (ASAT/ALAT of >2N, elevated bilirubin level, PT of <50%).
  • Preoperative sepsis, septic shock.
  • Preoperative norepinephrine infusion.
  • Patients eligible for a surgical procedure under locoregional anaesthesia.
  • Pregnancy.
  • Known allergy to study treatment.
  • Patients unable to give informed consent for any reason.

Study details

Norepinephrine, Hypotension, Anesthesiology, Major Abdominal Surgery

NCT05276596

Centre Hospitalier Universitaire, Amiens

2 June 2025

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