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Randomized Controlled Trial
. 2025 Mar 11;29(1):108.
doi: 10.1186/s13054-025-05331-9.

Efficacy and safety of gastrodin in preventing postoperative delirium following cardiac surgery: a randomized placebo controlled clinical trial

Yun-Xiao Bai #  1   2   3 , Hui-Liang Wu #  4 , Wan-Li Xie #  1   2   3 , Xia Li  1   2   3 , Jing-Jing Han  1   2   3 , Jie Liu  1   2   3 , Shi-Qiang Chen  1   2   3 , Ping Yin  5 , Nian-Guo Dong  6 , Qing-Ping Wu  7   8   9
Affiliations
Randomized Controlled Trial

Efficacy and safety of gastrodin in preventing postoperative delirium following cardiac surgery: a randomized placebo controlled clinical trial

Yun-Xiao Bai et al. Crit Care. .

Abstract

Background: Delirium and postoperative cognitive dysfunction (POCD) are common complications post-cardiac surgery, yet no specific medical intervention is currently recommended for prevention. This study aimed to evaluate the efficacy of gastrodin infusion in preventing delirium and POCD in critically ill patients following cardiac surgery.

Material and methods: A double-blind, randomized, placebo-controlled trial was conducted on patients aged 18-75, scheduled for coronary artery bypass grafting (CABG) surgery, with or without valve replacement. Participants were randomized in a 1:1 ratio to receive gastrodin infusion 600 mg twice daily or placebo from the day of surgery until the postoperative day (POD) 6. The co-primary outcomes were the incidences of delirium and POCD, assessed from ICU admission until POD 7 and at 1 and 3 months postoperatively. This study was registered with the Chinese Clinical Trials Registry (ChiCTR1800020414).

Results: Of 160 randomized participants, 155 were analyzed (77 gastrodin, 78 placebo) according to a modified intention to treat principle. The incidence of postoperative delirium was 19.5% in the gastrodin group and 35.9% in the placebo group, with a significant relative risk of 0.54 (95% CI 0.32-0.93, p = 0.022). The incidence of in-hospital POCD was 2.9% and 4.0% in the placebo and gastrodin groups, respectively. The odds of hospital discharge were significantly greater in the gastrodin group (subhazard ratio, 1.20; 95% CI 1.00-1.84; p = 0.049). Adverse events occurred in 9.1% (7/77) of patients administered gastrodin and 14.1% (11/78) of patients administered the placebo, with none being drug-related.

Conclusion: Gastrodin infusion significantly reduced postoperative delirium and improved discharge outcomes in patients undergoing CABG, but larger studies are needed to confirm its efficacy in preventing delirium.

Keywords: Cardiac surgery; Delirium; Gastrodin.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study was conducted in accordance with the Declaration of Helsinki and national and institutional standards. The Institutional Ethics Committee approved this study (2018(S026)). Written informed consent was obtained from all participants before enrolment. Consent for publication: Not applicable. Competing interests: The authors declare that they have no competing interests.

Figures

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Fig. 1
Participant flow in the trial
Fig. 2
Fig. 2
Forest plot of primary endpoints
See this image and copyright information in PMC

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