Effect of dexmedetomidine on postoperative delirium in patients undergoing brain tumour resections: study protocol of a randomised controlled trial.

INTRODUCTION

Postoperative delirium (POD) is a common complication. The incidence of POD is about 25% in non-cardiac surgery and ranges from 10% to 30% in neurological procedures. A lot of trials show that dexmedetomidine might help to reduce the incidence of delirium in patients undergoing non-cardiac surgery. However, the impact of dexmedetomidine on POD for patients undergoing craniotomy and tumour resections remains unclear.

METHODS AND ANALYSIS

The study is a prospective, single-centre, randomised, double-blinded, paralleled-group controlled trial. Patients undergoing elective frontotemporal tumour resections will be randomly assigned to the dexmedetomidine group and the control group. After endotracheal intubation, patients in the dexmedetomidine group will be administered with a loading dose of dexmedetomidine 0.6 µg/kg in 10 min followed by continuous infusion at a rate of 0.4 µg/kg/hour until the start of dural closure. In the control group, patients will receive the identical volume of normal saline in the same setting. The primary outcome will be the cumulative incidence of POD within 5 days. The delirium assessment will be performed by using the confusion assessment method in the first 5 consecutive days after surgery. Secondary outcomes include the pain severity assessed by Numerical Rating Scale pain score, quality of postoperative sleep assessed by the Richards Campbell sleep questionnaire and postoperative quality of recovery from anaesthesia by the Postoperative Quality Recovery Scale.

ETHICS AND DISSEMINATION

The protocol (V.1.0, 10 November 2020) has been approved by the Ethics Review Committee of the Chinese Clinical Trial Registry (number ChiECRCT-20200436). The findings of the study will be disseminated in a peer-reviewed journal and at a scientific conference.

TRIAL REGISTRATION NUMBER

NCT04674241.