Early use of norepinephrine in high-risk patients undergoing for major abdominal surgery : The EPON single center randomized controlled trial

Position du problème et objectif(s) de l’étude

Intraoperative hypotension (IOH) is a strong factor of adverse outcomes in major abdominal surgery. However, data are scares on the occurrence of IOH during the induction for a general anesthesia. We hypothesized that the early prevention of post-induction hypotension, using a vasopressor, can prevent from postoperative adverse outcomes.Intraoperative hypotension (IOH) is a strong factor of adverse outcomes in major abdominal surgery. However, data are scares on the occurrence of IOH during the induction for a general anesthesia. We hypothesized that the early prevention of post-induction hypotension, using a vasopressor, can prevent from postoperative adverse outcomes.

Matériel et méthodes

We conducted a single-center randomized controlled trial. The study received favorable approval from an ethics committee prior to the inclusion of participants. The population study was adult patients older than 50 years and with ASA status over than 2 scheduled for major abdominal surgery with general anesthesia. Patients were allocated to either ephedrine group or norepinephrine group. In the ephedrine group, titration with iterative boluses of ephedrine (3 mg.ml-1) at the induction if IOH (defined by a mean arterial pressure under 65 mmHg) occurred. In the norepinephrine group, continuous intravenous injection of norepinephrine (0.016 mg.ml-1) was started at a rate of 0.48 mg.h-1 from the induction of anesthesia and was titrated if IOH occurred. The primary endpoint was the occurrence of medico-surgical complication within 30 days after surgery using the Clavien-Dindo score (≥1). The secondary endpoints were length of hospital stay, acute kidney injury, 1-month mortality, cardiovascular, respiratory, neurological and infectious complications

Résultats & Discussion

500 patients were recruited and 473 were included in the intention-to-treat analysis. The cumulative episodes of IOH were significantly lower in the norephedrine group in comparison to the ephedrine group (respectively, 35 (15%) vs 176 (74%); P<0.001). The primary endpoint occurred in 137 (58%) in the ephedrine group and 103 patients (44%) in the norepinephrine group (relative risk at 0.58 (0.40; 0.83); P=0.004). No significant differences were observed in secondary endpoints except for pulmonary complication (74 (31%) in ephedrine group vs 40 (17%) in norepinephrine group relative risk et 0,46 (0,29; 0,70), p<0,001) at 48 hours.

Conclusion

A prophylactic strategy using norepinephrine allowed a significant decrease in medico-surgical complication in major abdominal surgery.

Auteurs

Ottilie TROCHERIS-FUMERY (1) , Thibaut FLET (1), Cécilia SCETBON (1), Paul TARPIN (1), Jonathan MEYNIER (2), Rachid BADAOUI (1), Bruno DE BROCA (1), Charles SABBAGH (3), Jean Marc REGIMBEAU (3), Philippe DE SOUSA (4), Arthur FOULON (5), Estelle JOSSE (2), Hervé DUPONT (1), Stéphane BAR (1), Osama ABOU ARAB (1) - (1)Département Anesthésie Réanimation, Chu Amiens Picardie, Amiens, France, (2)Direction Recherche Clinique Et Innovation, Amiens, France, (3)Service De Chirurgie Digestive, Amiens, France, (4)Service De Chirurgie Urologique, Amiens, France, (5)Service De Chirurgie Gynécologique, Amiens, France

Orateur(s)

Ottilie TROCHERIS-FUMERY (Amiens)