Yoshitaka Aoki1,2, Yohei Kawasaki3,4, Kazuki Ide5, Yuichiro Shimizu6, Shinsuke Sato7, Junichiro Yokoyama6. 1. Department of Anesthesiology and Intensive Care Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-Ku, Hamamatsu-shi, Shizuoka, 431-3192, Japan. ysyaoki27@gmail.com. 2. Department of Anesthesiology, Shizuoka General Hospital, Shizuoka, Japan. ysyaoki27@gmail.com. 3. Biostatistics Section, Clinical Research Centre, Chiba University Hospital, Chiba, Japan. 4. Faculty of Nursing, Japanese Red Cross College of Nursing, Tokyo, Japan. 5. Uehiro Research Division for iPS Cell Ethics, Center for iPS Cell Research and Application, Kyoto University, Kyoto, Japan. 6. Department of Anesthesiology, Shizuoka General Hospital, Shizuoka, Japan. 7. Department of Gastroenterological Surgery, Shizuoka General Hospital, Shizuoka, Japan.
Abstract
INTRODUCTION:Landiolol hydrochloride reduces the incidence of perioperative atrial fibrillation (AF) in cardiac surgery; however, little evidence is available regarding its effects in other types of surgery, including esophagectomy. We assessed the hypothesis that landiolol reduces perioperative AF and other complications associated with esophagectomy. METHODS: This single-center, randomized, double-blind, parallel-group study enrolled patients scheduled for esophagectomy. Patients were divided into those given landiolol at 3 μg/kg/min or placebo for 24 h. The primary outcome was the proportion of patients who developed AF within 96 h starting at 9:00 AM on the day of surgery. The secondary outcomes were the proportion of patients whose AF appeared within 24 h, other complications based on the Clavien-Dindo classification, and the intensive care unit and hospital stays. RESULTS: Despite early study termination, 80 patients were screened, and 56 were enrolled (28/group) from September 2016 to June 2018. AF occurred within 96 h of surgery in six (21.4%) patients in the landiolol group and five (17.9%) patients in the placebo group (odds ratio, 1.26; 95% confidence interval, 0.33-4.7) and within 24 h of surgery in three (10.7%) patients in the landiolol group and two (7.1%) patients in the placebo group. There were no significant differences in the incidence of complications or in the number of intensive care unit or hospital stays between the groups. CONCLUSION: Although our small sample size prevents definitive conclusions, landiolol might not reduce the occurrence of AF or other complications. TRIAL REGISTRATION: UMIN, UMIN000024040. Registered 13 September 2016, http://www.umin.ac.jp/ctr/index/htm.
RCT Entities:
INTRODUCTION:Landiolol hydrochloride reduces the incidence of perioperative atrial fibrillation (AF) in cardiac surgery; however, little evidence is available regarding its effects in other types of surgery, including esophagectomy. We assessed the hypothesis that landiolol reduces perioperative AF and other complications associated with esophagectomy. METHODS: This single-center, randomized, double-blind, parallel-group study enrolled patients scheduled for esophagectomy. Patients were divided into those given landiolol at 3 μg/kg/min or placebo for 24 h. The primary outcome was the proportion of patients who developed AF within 96 h starting at 9:00 AM on the day of surgery. The secondary outcomes were the proportion of patients whose AF appeared within 24 h, other complications based on the Clavien-Dindo classification, and the intensive care unit and hospital stays. RESULTS: Despite early study termination, 80 patients were screened, and 56 were enrolled (28/group) from September 2016 to June 2018. AF occurred within 96 h of surgery in six (21.4%) patients in the landiolol group and five (17.9%) patients in the placebo group (odds ratio, 1.26; 95% confidence interval, 0.33-4.7) and within 24 h of surgery in three (10.7%) patients in the landiolol group and two (7.1%) patients in the placebo group. There were no significant differences in the incidence of complications or in the number of intensive care unit or hospital stays between the groups. CONCLUSION: Although our small sample size prevents definitive conclusions, landiolol might not reduce the occurrence of AF or other complications. TRIAL REGISTRATION: UMIN, UMIN000024040. Registered 13 September 2016, http://www.umin.ac.jp/ctr/index/htm.