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

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Hypotension; Major Abdominal Surgery; Norepinephrine; Anesthesiology

Treatments: Drug: Ephedrine; Drug: Norepinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT05276596

PI2021_843_0060

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for major abdominal surgery
• ASA 2 or more patients
• Adults> 50 years old
• Patients eligible for general anesthesia

Exclusion criteria

• Patients scheduled for will be excluded and excluded from the study:
• ASA 1
• Children and adults <or = 50 years old
• Urgent surgery
• Allergy to a product used in the study
• Severe untreated or uncontrolled high blood pressure despite taking medication
• Acute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome
• Chronic kidney disease with a glomerular filtration rate of less than 30 ml / min / 1.73 m2 or requiring renal replacement treatment in the event of end-stage renal failure
• Preoperative sepsis
• Circulatory shock
• Preoperative noradrenaline infusion before entering the study
• Surgical procedure under regional anesthesia (epidural and spinal anesthesia)
• No affiliation with the French health system
• Participation in another concurrent intervention study
• Refusal to participate
• Pregnant or lactating women

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Control group

Active Comparator group

Description:

The first anesthetic post-induction hypotension will be managed by intravenous injection of ephedrine (dilution: 3 mg / ml) at a dose of 6 mg (i.e. 2 ml). Any subsequent hypotension will be treated with ephedrine until injection of a total dose of 30 mg. Thereafter, if a new arterial hypotension occurs, we will pass to the administration of noradrenaline in intravenous injection using an electric syringe pump, at the dilution of 0.016 mg / ml, posology adapted to the objectives. blood pressure.

Treatment:

Drug: Ephedrine

Test group

Experimental group

Description:

Immediately use of norepinephrine by intravenous injection using an electric syringe pump, at a dilution of 0.016 mg / ml, at the time of anesthetic induction and without waiting the 1st possible arterial hypotension. Noradrenaline will be started at a dose of 0.48 mg / h and then adapted according to the blood pressure objectives.

Treatment:

Drug: Norepinephrine