Effect of remimazolam on electroencephalogram burst suppression in elderly patients undergoing cardiac surgery: Protocol for a randomized controlled noninferiority trial
Zheng-min Ma,
Jing-hui Hu,
Yao-yu Ying,
Xian Chen,
Jing-ya Xu,
Wen-wen Huo,
Hong Liu,
Fu-hai Ji,
Ke Peng
Affiliations
Zheng-min Ma
Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China; Institute of Anesthesiology, Soochow University, Suzhou, Jiangsu, China
Jing-hui Hu
Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China; Institute of Anesthesiology, Soochow University, Suzhou, Jiangsu, China
Yao-yu Ying
Department of Medical Affairs, The Second Affiliated Hospital of Soochow University, Suzhou, China; Department of Epidemiology and Biostatistics, Soochow University Medical College, Suzhou, China
Xian Chen
Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China; Institute of Anesthesiology, Soochow University, Suzhou, Jiangsu, China
Jing-ya Xu
Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China; Institute of Anesthesiology, Soochow University, Suzhou, Jiangsu, China
Wen-wen Huo
Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China; Institute of Anesthesiology, Soochow University, Suzhou, Jiangsu, China
Hong Liu
Department of Anesthesiology and Pain Medicine, University of California Davis Health, Sacramento, CA, USA
Fu-hai Ji
Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China; Institute of Anesthesiology, Soochow University, Suzhou, Jiangsu, China
Ke Peng
Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China; Institute of Anesthesiology, Soochow University, Suzhou, Jiangsu, China; Corresponding author. Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China.
Background: Postoperative delirium (POD) is a common complication following cardiac surgery and increases postoperative morbidity and mortality. Intraoperative electroencephalogram (EEG) burst suppression suggests excessively deep anesthesia and predicts POD. Use of remimazolam provides a stable hemodynamic status and an appropriate depth of anesthesia. We aim to assess remimazolam administered for anesthesia and sedation in elderly patients having cardiac surgery. Methods: This is a randomized controlled clinical trial with noninferiority design. A total of 260 elderly patients aged equal to or greater than 60 years undergoing cardiac surgery will be randomly allocated to receive remimazolam or propofol (1:1) for general anesthesia and postoperative sedation until extubation. The primary outcome is the cumulative time with EEG burst suppression which is obtained from the SedLine system. The noninferiority margin is 2.0 min. The secondary outcomes include the POD occurrence within the first 5 days postoperatively and the duration of perioperative hypotension. Discussion: This noninferiority trial is the first to evaluate the effect of perioperative remimazolam administration on EEG burst suppression, POD occurrence, and duration of hypotension in elderly patients who undergo cardiac surgery. Trial registration: Chinese Clinical Trial Registry (ChiCTR2200056353).
