BACKGROUND:The EPITUBE trial aimed to determine whether a prophylactic infusion of norepinephrine reduced severe hypotension after induction of general anaesthesia and tracheal intubation in patients undergoing cardiac surgery.
METHODS:We performed a randomised controlled single-centre clinical trial including patients undergoing cardiac surgery. In the experimental group, infusion of norepinephrine started from the start of preoxygenation at an infusion rate of 0.06 μg kg-1 min-1, secondarily titrated to maintain mean arterial pressure (MAP) between 65 and 80 mm Hg. In the control group, ephedrine was administered if MAP decreased <65 mm Hg. Primary outcome was the occurrence of MAP <55 mm Hg. Secondary measures included tracheal intubation-related complications, postoperative complications, duration of ICU stay, and mortality.
RESULTS:Of 210 patients randomised and analysed in the intention-to-treat analysis, the incidence of severe hypotension was not different between the groups: 43.8% in the norepinephrine group vs 44.8% in the control group (odds ratio 0.96, 95% confidence interval [CI] 0.56-1.66, P=0.99). The incidence of MAP <65 mm Hg was lower in the norepinephrine group than in the control group: 63.8% vs 78.1% (odds ratio 0.49, 95% CI 0.26-0.90, P=0.02). The rate of intubation-related complications was not different between the norepinephrine and control groups, 22.9% vs 32.4%, respectively (odds ratio 0.62, 95% CI 0.33-1.14, P=0.13). There was no difference in postoperative outcomes including acute kidney injury, time on ventilator, or length of stay in the ICU.
CONCLUSIONS:In patients undergoing cardiac surgery, infusion of norepinephrine before general anaesthesia at a starting dose of 0.06 μg kg-1 min-1 did not reduce severe hypotension compared with on-demand ephedrine.
CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT05335954.