Effect of Dexmedetomidine on Postoperative Delirium in Elderly Patients With Parkinson's Disease Undergoing Deep Brain Stimulation: a Randomized Controlled Trial

20220106

Postoperative delirium (POD) is a common complication, and the incidence of POD after deep brain stimulation(DBS) implementation ranges from 10% to 40%. Previous studies suggested that aging and existing non-motor symptom were independent risk factors for POD after supratentorial tumor resections. Therefore, patients undergoing DBS are high-risk populations for POD. 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 DBS was seldom reported. The purpose of this study was to investigate the effect of dexmedetomidine on POD in patients with Parkinson' Disease undergoing DBS.

2023-12-01

2024-11-30

2024-12-31

Not yet recruiting

192

Inclusion Criteria: * Patients with Parkinson's Disease * Exist non-motor symptoms * Undergoing selective DBS. * Age ≥60 years. * Obtain written informed consent. Exclusion Criteria: * preoperative severe cognitive impairment (Montreal Cognitive Assessment, MoCA\< 18) * history of psychoactive * allergic or intolerant to dexmedetomidine * severe bradycardia (heart rate lower than 40 beats/min) or sick sinus syndrome, second-degree or third-degree atrioventricular block * severe hepatic dysfunction (Child-Pugh class C) * severe renal dysfunction requiring renal replacement therapy before the surgery * medical records documented inability to communicate in the preoperative period due to language barrier or other situations.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 192, 'type': 'ESTIMATED'}}

2023-06-15