Randomized Controlled Trial
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Jul 26, 2021; 9(21): 5909-5920
Published online Jul 26, 2021. doi: 10.12998/wjcc.v9.i21.5909
Effects of perioperative rosuvastatin on postoperative delirium in elderly patients: A randomized, double-blind, and placebo-controlled trial
Xiao-Qin Xu, Jing-Zhi Luo, Xiao-Yu Li, Hai-Qin Tang, Wei-Hong Lu
Xiao-Qin Xu, Jing-Zhi Luo, Xiao-Yu Li, Hai-Qin Tang, Wei-Hong Lu, Department of Anesthesiology, Wuxi Clinical College of Anhui Medical University, 904th Hospital of Joint Logistic Support Force of PLA, Wuxi Clinical College of Anhui Medical University, Wuxi 214044, Jiangsu Province, China
Author contributions: Xu XQ, Li XY, and Luo JZ designed the study and analyzed the data; Tang HQ, Lu WH, and Luo JZ collected the data; Xu XQ and Li XY interpreted the data; Xu XQ, Li XY, Tang HQ, Lu WH, and Luo JZ prepared the manuscript; all authors have read and approved the manuscript.
Institutional review board statement: The study protocol was approved by the Clinical Research Ethics Committees of Anhui Medical University Affiliated with Wuxi Clinical College (ChiCTR-IPR-17011984 and YXLL-2017-02). The study protocol received Ethics Committee approval from all participating centers. Written informed consent was obtained from patients whose competence was established by their accurate orientation for time, place, and person, as well as an understanding of the recruiter’s description of the trial, or otherwise from their next of kin or their legal representative.
Clinical trial registration statement: Chictr.org.cn, ChiCTR-IPR-17011984 (registration date: 13/07/2017).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors have no competing interests to declare.
Data sharing statement: The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Xiao-Yu Li, MM, Chief Nurse, Department of Anesthesiology, Wuxi Clinical College of Anhui Medical University, 904th Hospital of Joint Logistic Support Force of PLA, Wuxi Clinical College of Anhui Medical University, No. 101 Xingyuan North Road, Wuxi 214044, Jiangsu Province, China. 742888988@qq.com
Received: March 30, 2021
Peer-review started: March 30, 2021
First decision: April 28, 2021
Revised: May 4, 2021
Accepted: June 7, 2021
Article in press: June 7, 2021
Published online: July 26, 2021
ARTICLE HIGHLIGHTS
Research background

Our previous basic research study found that statins exert pleiotropic effects, including anti-inflammatory and antioxidative stress effects, inhibition of platelet aggregation, and promotion of neuroprotection. The anti-delirium role of statins was not clearly determined in recent studies.

Research motivation

Delirium is a severe clinical syndrome characterized by a temporary organic mental disorder, which may induce long-term cognitive impairment, death/disability, and increased length of hospital stay and costs. An increasing number of basic research studies indicate that statins play an important role in postoperative delirium. Our preliminary clinical experiment also revealed that perioperative rosuvastatin had potential value as a treatment for postoperative delirium.

Research objectives

This randomized, double-blind, and placebo-controlled trial explored the anti-delirium effect of perioperative rosuvastatin and compared the clinical efficacy and economic efficiency, as well as the safety of perioperative rosuvastatin, in elderly patients who underwent surgery under general anesthesia.

Research methods

This randomized, double-blind, and placebo-controlled trial was conducted in a single center and enrolled patients aged more than 60 years who underwent an elective operation under general anesthesia. The patients were randomly assigned to receive either rosuvastatin (40 mg/d) or placebo.

Research results

The final analysis included 411 patients in the placebo group and 410 patients in the rosuvastatin group. The incidence of postoperative delirium was significantly lower in the rosuvastatin group than in the placebo group (P < 0.05). No significant difference in 30-d all-cause mortality was observed between the two groups (P > 0.05). Rosuvastatin decreased the hospitalization time and hospitalization expenses (P < 0.057). No significant differences in abnormal liver enzyme levels or rhabdomyolysis were observed between the two groups (P > 0.05).

Research conclusions

Perioperative rosuvastatin treatment potentially reduces the incidence of delirium after an elective operation under general anesthesia, without a higher incidence of drug-related complications.

Research perspectives

In the future, a large prospective randomized investigation will definitively address the effect of rosuvastatin on postoperative delirium in elderly patients undergoing an elective operation under general anesthesia.