2: Evaluation of role of exogenous melatonin in prevention of delirium in postoperative patients admitted in intensive care unit : a randomised placebo-controlled study

Abstract

Background and Aims:Delirium is extremely prevalent in hospitalised patients; 37–46% of the general surgical population and in up to 87 % of patients in the intensive care unit (ICU).Melatonin – a potential agent in the management of delirium since its low plasma concentrations and altered secretion patterns have been found in the critically ill (6-sulphatoxymelatonin (MT6) in subjects’ urine). To establish the reduction in incidence of delirium [as determined by the confusion assessment method (CAM-ICU) scale], in post operative patients admitted in ICU after administration of exogenous oral melatonin ,and determining the association of acute physiology and chronic health evaluation (APACHE) II and sequential organ failure assessment (SOFA) scores with occurrence of delirium.Methods:140 post operative patients admitted in the ICU , comparable on the basis of age, gender, APACHE II and SOFA scores were randomly divided into two groups ; CASES and CONTROLS with 70 patients each. In this double blind , randomized placebo control study ,CASES(group A) were administered Tablet Melatonin 5mg at 8pm everyday through Ryle’s Tube and CONTROLS(group B) were given 1gm lactose powder indistinguishable from study .Both drugs were given everyday till ICU discharge/transfer.At discharge/transfer, the patients were assessed and categorised as “Delirious” and “Not delirious” using the CAM-ICU scale.Results:Incidence of delirium patients was lower in Group A(16.6%) as compared to group B ( 31.4%).Patients with delirium as compared to non-delirium had higher values of APACHE-II (20.57±6.26 vs. 18.42±7.14) and SOFA score (4.49±1.63 vs. 1.75±1.37).The incidence of delirium increased with age since mean age was greater in those with delirium (41.57±9.99 vs. 35.87±11.81). The incidence of delirium did not vary significantly with gender.Between Group Comparison of Outcome¸²=3.665; p=0.160Conclusion:The reduced incidence of delirium in the cases (group A) indicated that Melatonin can be a potential drug for the prevention of delirium in the critically ill. APACHE II and SOFA scores can be used as individual predictors of delirium, owing to significantly higher values of these scores in delirious patients when compared to those without delirium.OutcomeTotal (n=140)Group A (n=70)Group B (n=70)Chi-square test No.%No.% χ 2 P Death291420.01521.40.0430.835Delirious351316.62231.43.0860.079Not delirious764361.43347.12.8780.090