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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05276596

Collaborator

(none)

500

Enrollment

Location

Arms

Anticipated Duration (Months)

13.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Norepinephrine Hypotension Anesthesiology Major Abdominal Surgery	Drug: Ephedrine Drug: Norepinephrine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 3, 2022

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group 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.	Drug: Ephedrine The control group will be taken care of according to the protocols in force. 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.
Experimental: Test group 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.	Drug: Norepinephrine 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.

Arm

Intervention/Treatment

Active Comparator: Control group

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.

Drug: Ephedrine

The control group will be taken care of according to the protocols in force. 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.

Experimental: Test group

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.

Drug: Norepinephrine

Outcome Measures

Primary Outcome Measures

Variation of the of the Clavien Dindo surgical score between both groups [one month]
The Clavien-Dindo Classification The therapy used to correct a specific complication is the basis of this classification in order to rank a complication in an objective and reproducible manner. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study. Complications that have the potential for long-lasting disability after patient's discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life

Secondary Outcome Measures

Variation of duration of hospital stay in days between both groups [one month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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