Effect of Dexmedetomidine on Postoperative Delirium in Elderly Patients With Parkinson's Disease Undergoing Deep Brain Stimulation: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Dexmedetomidine
- Conditions
- Dexmedetomidine
- Sponsor
- Beijing Tiantan Hospital
- Enrollment
- 192
- Locations
- 1
- Primary Endpoint
- The incidence of postoperative delirium.
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Yuming Peng
Deputy chief of Department of Anesthesiology
Beijing Tiantan Hospital
Eligibility Criteria
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.
Arms & Interventions
DEX group
Dexmedetomidine will be given at the beginning of the second step of DBS and last for 48 hours by electronic pump.
Intervention: Dexmedetomidine
Placebo group
The placebo group patients will be received 0.9% saline intraoperatively and postoperatively the same duration just like the DEX group would do.
Intervention: 0.9% saline
Outcomes
Primary Outcomes
The incidence of postoperative delirium.
Time Frame: Postoperative 5 days
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.
Secondary Outcomes
- Quality of sleep(the second and the third day after surgery)
- Postoperative pain(within 3 days after surgery.)
- Quality of recovery.(First day after surgery)
- The severity of postoperative delirium.(Postoperative 5 days)
- Cognitive function(before surgery and 5 days after surgery)
- Anxiety and depression(before surgery and 5 days after surgery)
- Parkinson's disease related status(before surgery and 5 days after surgery)