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

2025-03-11
Critical care (London, England) 29(1)
- Yun-Xiao Bai
- Hui-Liang Wu
- Wan-Li Xie
- Xia Li
- Jing-Jing Han
- Jie Liu
- Shi-Qiang Chen
- Ping Yin
- Nian-Guo Dong
- Qing-Ping Wu

PubMed: 40069830
DOI: 10.1186/s13054-025-05331-9

Study Design

Type: Randomized Controlled Trial (RCT)
Population: patients aged 18-75 scheduled for CABG surgery with or without valve replacement
Methods: Double-blind RCT, gastrodin infusion 600 mg twice daily vs placebo from day of surgery until POD 6
Blinding: Double-blind
Duration: from day of surgery until postoperative day 6
Funding: Unclear

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.

Research Insights

Gastrodia→Improved Hospital Discharge
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).
Effect
Beneficial
Effect size
Moderate
Dose
600 mg twice daily
Gastrodia→Reduced Postoperative Cognitive Dysfunction Incidence
The incidence of in-hospital POCD was 2.9% and 4.0% in the placebo and gastrodin groups, respectively.
Effect
Neutral
Effect size
Small
Dose
600 mg twice daily
Gastrodia→Reduced Postoperative Delirium Incidence
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).
Effect
Beneficial
Effect size
Large
Dose
600 mg twice daily

Adverse Events Reported

Gastrodia→Overall tolerability
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.
Finding
Reported