Methylene blue reduces incidence of early postoperative cognitive disorders in elderly patients undergoing major non-cardiac surgery: An open-label randomized controlled clinical trial.

STUDY OBJECTIVE: The purpose of the present study was to investigate whether methylene blue (MB) could reduce the incidences of postoperative delirium (POD) and early postoperative cognitive dysfunction (POCD) in elderly patients undergoing major non-cardiac surgery.

DESIGN: Prospective, randomized, open-label clinical trial.

SETTING: University-affiliated hospital.

PATIENTS: Two hundred and forty-eight elderly patients scheduled for non-cardiac surgery.

INTERVENTIONS: Elderly patients undergoing non-cardiac major surgery were randomly assigned to MB group (n = 124), who receiving intravenous infusion of 2 mg/kg MB within 60 min immediately after anesthetic induction, or control group (n = 124), who receiving equal volume saline in the same way.

MEASUREMENTS: All patients were evaluated with delirium and neuropsychological batteries before and after surgery, as well as perioperative adverse events. Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY) were measured pre- and post-operatively.

MAIN RESULTS: There were total 39 cases(15.7%)experienced POD. The incidence of POD in MB group was significantly less than that in control group (7.3% vs. 24.2%, OR = 0.24, 95%CI: 0.11-0.53, p < 0.001). The incidence of early POCD at postoperative 7th day in MB group was also less than that in control group (16.1% vs. 40.2%, OR = 0.30, 95% CI: 0.16-0.57, p < 0.001). The adverse events were comparable in both groups. In addition, there was no significant correlation between POD/POCD and levels of SOD or HCY.

CONCLUSION: We conclude that intraoperative intravenous 2 mg/kg MB could significantly reduce the incidences of POD and early POCD in elderly surgical patients, while not remarkably increase incidence of perioperative adverse events, suggesting MB may be clinically effective and safe for prevention of early postoperative neurocognitive disorders.