Prevention of delirium with agitation by yokukansan in older adults after cancer surgery.

2022-11-01
Japanese journal of clinical oncology 52(11)
- Ryoichi Sadahiro
- Saho Wada
- Yutaka J Matsuoka
- Yosuke Uchitomi
- Takuhiro Yamaguchi
- Tetsufumi Sato
- Minoru Esaki
- Seiichi Yoshimoto
- Hiroyuki Daiko
- Yukihide Kanemitsu
- Akira Kawai
- Tomoyasu Kato
- Hiroyuki Fujimoto
- Yasuhito Uezono
- Ken Shimizu
- Hiromichi Matsuoka

PubMed: 35907781
DOI: 10.1093/jjco/hyac123

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 149
Population: 149 patients from a previous clinical trial; patients undergoing highly invasive cancer resection; subgroups aged ≥65 years (n=82) and ≥75 years (n=21)
Methods: Secondary per-protocol analysis of data from a previous clinical trial; patients underwent scheduled yokukansan or placebo intervention 4-8 days presurgery and delirium assessment postoperatively; odds ratios assessed using logistic regression
Duration: 4-8 days presurgery

Large Human Trial

Objective

Preventing postoperative delirium with agitation is vital in the older population. We examined the preventive effect of yokukansan on postoperative delirium with agitation in older adult patients undergoing highly invasive cancer resection.

Methods

We performed a secondary per-protocol analysis of 149 patients' data from a previous clinical trial. Patients underwent scheduled yokukansan or placebo intervention 4-8 days presurgery and delirium assessment postoperatively. Delirium with agitation in patients aged ≥75 years was assessed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, and the Japanese version of the Delirium Rating Scale-Revised-98. We assessed odds ratios for yokukansan (TJ-54) compared with placebo for the manifestation of postoperative delirium with agitation across patients of all ages (n = 149) and those aged ≥65 years (n = 82) and ≥ 75 years (n = 21) using logistic regression.

Results

Delirium with agitation manifested in 3/14 and 5/7 patients in the TJ-54 and placebo groups, respectively, among those aged ≥75 years. The odds ratio for yokukansan vs. placebo was 0.11 (95% confidence interval: 0.01-0.87). An age and TJ-54 interaction effect was detected in patients with delirium with agitation. No intergroup differences were observed in patients aged ≥65 years or across all ages for delirium with agitation.

Conclusions

This is the first study investigating the preventive effect of yokukansan on postoperative delirium with agitation in older adults. Yokukansan may alleviate workforce burdens in older adults caused by postoperative delirium with agitation following highly invasive cancer resection.