Dexmedetomidine Prevents Postoperative Delirium After Deep Brain Stimulation in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Dexmedetomidine, Postoperative Delirium, Deep Brain Stimulation

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: 0.9% saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DEX group<br>Dexmedetomidine will be given at the beginning of the second step of DBS and last for 48 hours by electronic pump. | Drug: Dexmedetomidine<br>* The 4.8ug/kg dexmedetomidine will be diluted into 100ml and pump 2ml/h at the beginning of the second of DBS and last for 48 hours.<br>|
| Placebo Comparator: Placebo group<br>The placebo group patients will be received 0.9% saline intraoperatively and postoperatively the same duration just like the DEX group would do. | Drug: 0.9% saline<br>* The 0.9% saline is administered with the same volume at the same speed as the other group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of postoperative delirium. | Postoperative delirium is assessed by the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) as applicable. | Postoperative 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severity of postoperative delirium. | The severity of postoperative delirium will be assessed by Delirium Rating Scale-Revised-98. | Postoperative 5 days | 
| Postoperative pain | Postoperative pain will be assessed with Numerical Rating Scale (NRS). Postoperative analgesia will be recorded. | within 3 days after surgery. | 
| Quality of recovery. | Quality of recovery will be evaluated with 15-item quality of recovery questionnaire (QoR-15). | First day after surgery | 
| Quality of sleep | Quality of sleep will be evaluated with the Richards Campbell sleep questionnaire (RCSQ). | the second and the third day after surgery | 
| Cognitive function | Cognitive function will be assessed using the Mini-Mental State Examination (MMSE) and the Montreal cognitive assessment-basic (MoCA-B). | before surgery and 5 days after surgery | 
| Anxiety and depression | Anxiety and depression will be evaluated using Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionaire-9 items (PHQ -9). | before surgery and 5 days after surgery | 
| Parkinson's disease related status | Parkinson's disease related status will be evaluated by Movement Disorder Society-Sponsored Revision Unified Parkinson's Disease Rating Scale (MDS-UPDRS). | before surgery and 5 days after surgery |