The Effect of Ramelteon on Postoperative Delirium in Elderly Patients: A Randomised Double-Blind Study

Abstract

Introduction: Delirium is known as an acute mental disturbance characterised by confused thinking and disrupted attention that is usually accompanied by disordered speech and hallucination. Delirium often is seen in patients post-surgery. Use of Melatonin pre-operatively decreases the incidence of post-operative delirium. Ramelteon is an agonist of melatonin having longer half-life than melatonin. Aim: To evaluate the efficacy of Ramelteon for the prevention of post-operative delirium in elderly patients. Materials and Methods: In this randomised controlled double-blind (all places) study, 50 patients with ASA I and II were selected and randomly assigned to each group. Group I received one tablet of Ramelteon (8 mg) 12 hours before surgery and 1 tablet of Ramelteon (8 mg) 1 hour before surgery and Group II received placebo one tablet 12 hours before surgery and 1 tablet 1 hour before surgery. Incidence of delirium was assessed by Confusion Assessment Method (CAM) at 1st, 2nd and 3rd day. The SPSS Version 21.0 was used for the statistical analyses and p-value <0.05 was considered as significant. The Chi-square test was used to compare the categorical variables between the groups. Unpaired t-test was used to compare the continuous variables between the groups. Results: Only two patients developed delirium in Ramelteon group, one patient at Day 2 and one patient at Day 3; but in control group, six patients develop delirium, three patients at day two and three patients at Day 3. The incidence of delirium in Ramelteon group was lower in comparison with placebo group but it was not statistically significant. Conclusion: Thus, it was observed that Ramelteon administration in pre-operative period decreases (nonsignificantly) the incidence of post-operative delirium with higher sedation scores. So Ramelteon can be recommended in the patients having high risk of developing post-operative delirium.

Keywords

• melatonin
• placebo
• post-operative
• prevention