Journal Article

Evaluation of the early use of norepinephrine in major abdominal surgery on medical and surgical postoperative complications: study protocol for a randomised controlled trial (EPON STUDY)

Scetbon, Cecilia, Tarpin, Paul, Trocheris-Fumery, Ottilie, Dupont, Herve, Abou-Arab, Osama, Rumbach, Matthieu, Bar, Stephane, Sellier, Magali, Flet, Thibault, Badaoui, Rachid, Villeret, Léonie, Meynier, Jonathan

2024

Overview

BackgroundPost-induction anaesthesia often promotes intraoperative hypotension (IOH) that can worsen postoperative outcomes. This study aims to assess the benefit of norepinephrine versus ephedrine at the induction of anaesthesia to prevent postoperative complications following major abdominal surgery by preventing IOH.Methods and analysisThe EPON STUDY is a prospective single-centre randomised controlled trial with the planned inclusion of 500 patients scheduled for major abdominal surgery at the Amiens University Hospital. The inclusion criteria are patients aged over 50 years weighing more than 50 kg with an American Society of Anesthesiologists physical status score of ≥2 undergoing major abdominal surgery under general anaesthesia. Patients are allocated either to the intervention group (n=250) or the standard group (n=250). In the intervention group, the prevention of post-induction IOH is performed with norepinephrine (dilution to 0.016 mg/mL) using an electric syringe pump at a rate of 0.48 mg/h (30 mL/h) from the start of anaesthesia and then titrated to achieve the haemodynamic target. In the control group, the prevention of post-induction IOH is performed with manual titration of ephedrine, with a maximal dose of 30 mg, followed by perfusion with norepinephrine. In both groups, the haemodynamic target to maintain is a mean arterial pressure (MAP) of 65 mm Hg or 70 mm Hg for patients with a medical history of hypertension. An intention-to-treat analysis will be performed. The primary outcome is the Clavien–Dindo score assessed up to 30 days postoperatively. The secondary endpoints are the length of hospital stay and length of stay in an intensive care unit/postoperative care unit; postoperative renal function; postoperative cardiovascular, respiratory, neurological, haematological and infectious complications at 1 month; and volume of intraoperative vascular filling and mortality at 1 month.Ethics and disseminationEthical approval was obtained from the committee of protection of the persons of Ile de France in May 2021 (number 21 05 41). The authors will be involved in disseminating the research findings (through attending conferences and co-authoring papers). The results of the study will be disseminated via peer-reviewed publications and presentations at national and international conferences.Trial registration number NCT05276596.

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Abdomen / Abdomen - surgery / Abdominal surgery / Acute coronary syndromes / Adult anaesthesia / Adult surgery / Anaesthesia / Anesthesia, General - adverse effects / Blood Pressure / Consent / Drugs / Endoscopy / Ephedrine - administration & dosage / Ephedrine - therapeutic use / Female / General anesthesia / Hemodynamics / Human health and pathology / Humans / Hypertension / Hypotension / Hypotension - prevention & control / Intensive care / Intervention / Intraoperative Complications - prevention & control / Life Sciences / Male / Middle Aged / Norepinephrine - administration & dosage / Norepinephrine - therapeutic use / Patients / Postoperative Complications - prevention & control / Prospective Studies / Randomized Controlled Trials as Topic / Sepsis / Surgery / Surgical outcomes / Vasoconstrictor Agents - administration & dosage / Vasoconstrictor Agents - therapeutic use / Ventilators