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

doi:10.1016/j.heliyon.2023.e23879

Effect of remimazolam on electroencephalogram burst suppression in elderly patients undergoing cardiac surgery: Protocol for a randomized controlled noninferiority trial

Heliyon. 2023 Dec 18;10(1):e23879. doi: 10.1016/j.heliyon.2023.e23879. eCollection 2024 Jan 15.

Authors

Zheng-Min Ma^{1

2}, Jing-Hui Hu^{1

2}, Yao-Yu Ying^{3

4}, Xian Chen^{1

2}, Jing-Ya Xu^{1

2}, Wen-Wen Huo^{1

2}, Hong Liu⁵, Fu-Hai Ji^{1

2}, Ke Peng^{1

2}

Affiliations

¹ Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China.
² Institute of Anesthesiology, Soochow University, Suzhou, Jiangsu, China.
³ Department of Medical Affairs, The Second Affiliated Hospital of Soochow University, Suzhou, China.
⁴ Department of Epidemiology and Biostatistics, Soochow University Medical College, Suzhou, China.
⁵ Department of Anesthesiology and Pain Medicine, University of California Davis Health, Sacramento, CA, USA.

Abstract

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).

Keywords: Cardiac surgery; Elderly patients; Electroencephalogram burst suppression; Postoperative delirium; Remimazolam.