Comparison of landiolol and amiodarone for the treatment of new-onset atrial fibrillation after cardiac surgery (FAAC) trial: study protocol for a randomized controlled trial.

BACKGROUND: Postoperative atrial fibrillation (PoAF) after cardiac surgery has a high incidence of 30%, but its management is controversial. Two strategies are recommended without evidence of a superiority of one against the other: rate control with beta-blocker or rhythm control with amiodarone. Landiolol is a new-generation beta-blocker with fast onset and short half-life. One retrospective, single-center study compared landiolol to amiodarone for PoAF after cardiac surgery with a better hemodynamic stability and a higher rate of reduction to sinus rhythm with landiolol, justifying the need for a multicenter randomized controlled trial. Our aim is to compare landiolol to amiodarone in the setting of PoAF after cardiac surgery with the hypothesis of a higher rate of reduction to sinus rhythm with landiolol during the 48 h after the first episode of POAF. METHODS: The FAAC trial is a multicenter single-blind two parallel-arm randomized study, which planned to include 350 patients with a first episode of PoAF following cardiac surgery. The duration of the study is 2 years. The patients are randomized in two arms: a landiolol group and an amiodarone group. Randomization (Ennov Clinical®) is performed by the anesthesiologist in charge of the patient if PoAF is persistent for at least 30 min after correction of hypovolemia, dyskalemia, and absence of pericardial effusion on a transthoracic echocardiography done at bedside. Our hypothesis is an increase of the percentage of patients in sinus rhythm from 70 to 85% with landiolol in less than 48 h after onset of PoAF (alpha risk = 5%, power = 90%, bilateral test). DISCUSSION: The FAAC trial was approved by the Ethics Committee of EST III with approval number 19.05.08. The FAAC trial is the first randomized controlled trial comparing landiolol to amiodarone for PoAF after cardiac surgery. In case of higher rate of reduction with landiolol, this beta-blocker could be the drug of choice used in this context as to reduce the need for anticoagulant therapy and reduce the risk of complications of anticoagulant therapy for patients with a first episode of postoperative atrial fibrillation after cardiac surgery. TRIAL REGISTRATION: ClinicalTrials.gov NCT04223739. Registered on January 10, 2020.

A targeted remifentanil administration protocol based on the analgesia nociception index during vascular surgery.

BACKGROUND: The intraoperative modulation of opioids continues to be based on clinical signs. This may result in adverse events such as sympathetic reactivity or opioid-induced hyperalgesia. Recently, the Analgesia/Nociception Index (ANI), a non-invasive 0-100 index derived from heart rate variability analysis, has been proposed for nociception assessment. However, the ability of the ANI to adequately guide intraoperative opioid administration has never been demonstrated. We designed a prospective study to evaluate the ability of the ANI to guide remifentanil administration in vascular surgery. METHODS: One hundred and eighty adults presenting for elective surgery were included. All received total intravenous anaesthesia with propofol adjusted to entropy and remifentanil adjusted to the ANI. The primary endpoint was the number of patients without any episode of reactivity defined as a 20% increase in heart rate or arterial pressure or the occurrence of movement. Secondary endpoints included opioid use and maximal pain rate in the first postoperative day. RESULTS: Anaesthesia was achieved without any episode of reactivity in 160 (89%) patients. Twenty-five episodes of reactivity occurred in 20 (11%) patients. The median remifentanil dose was 0.042 [0.040-0.044]µg.kg-1.min-1. At 24hours, the maximal NRS pain score was 2 [2,3]. One hundred and fifty-five patients (86%) did not receive any postoperative opioids, whereas 25 (14%) received a median dose of 5[5-10] mg of oxycodone. CONCLUSION: This prospective study demonstrated that the ANI can be used to adequately guide intraoperative remifentanil administration during vascular surgery. Such guidance resulted in low remifentanil consumption, low postoperative pain rates and low opioid rescue analgesia.