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

Hypotension Clinical Trial

— EPON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05276596
• Other study ID #: PI2021_843_0060
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2022
• Est. completion date: April 2025

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Ottilie FUMERY- TROCHERIS, MD
• Phone: 03 22 08 78 36
• Email: fumery.ottilie[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesiology
• Hypotension
• Major Abdominal Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of the of the Clavien Dindo surgical score between both groups	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	one month
Secondary	Variation of duration of hospital stay in days between both groups		one month