Dexmedetomidine Evaluation for Reducing Cognitive Complications after Neurosurgery (DECCAN) - Study Protocol of a Randomised Controlled Trial

Abstract

Background: Perioperative neurocognitive disorders of Emergence Delirium (ED), Postoperative Delirium (POD), delayed Neurocognitive Recovery (dNCR), and postoperative Neurocognitive Disorder (pNCD) occur with varying incidences after anaesthesia and surgery. Considering their adverse impact on patient outcomes, several interventions are being explored. Dexmedetomidine has shown promise in reducing perioperative stress and lowering the incidence of POD. This study aimed to compare intraoperative dexmedetomidine versus saline infusion for postoperative cognitive complications after brain surgery. Methods: This prospective, single-centre, randomised controlled trial, funded by the Department of Science and Technology, India, was conducted in adult patients undergoing elective brain surgery under general anaesthesia over a 3-year period. Intraoperative dexmedetomidine started at 0.5 μg/kg/h was compared to saline infusion at a similar infusion rate after standard anaesthetic induction. A block randomisation was performed using a computer-generated random number table with a 1:1 allocation ratio. Patients, anesthesiologists, data collectors, and analysts were blinded to study interventions. Results: This trial was approved by the institute's ethics committee and is registered with the Clinical Trial Registry of India, and eligible patients are recruited. The primary outcomes are the incidence of ED within the first 60 minutes and the incidence of POD within the first 3 postoperative days. Secondary outcomes included postoperative sleep, biomarkers of surgical stress, acute and chronic pain, dNCR, pNCD, and quality of life at 1, 3, and 6 months. Conclusions: It is anticipated that dexmedetomidine will reduce adverse postoperative cognitive outcomes. The findings will be disseminated through conference presentations and scientific publications.