Dexmedetomidine Prevents Postoperative Delirium After Deep Brain Stimulation in Patients With Parkinson's Disease
- Conditions
- DexmedetomidinePostoperative DeliriumDeep Brain Stimulation
- Interventions
- Drug: 0.9% saline
- Registration Number
- NCT05197439
- Lead Sponsor
- Beijing Tiantan Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 192
- Patients with Parkinson's Disease
- Exist non-motor symptoms
- Undergoing selective DBS.
- Age ≥60 years.
- Obtain written informed consent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group 0.9% saline The placebo group patients will be received 0.9% saline intraoperatively and postoperatively the same duration just like the DEX group would do. DEX group Dexmedetomidine Dexmedetomidine will be given at the beginning of the second step of DBS and last for 48 hours by electronic pump.
- Primary Outcome Measures
Name Time Method The incidence of postoperative delirium. 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 Outcome Measures
Name Time Method Quality of sleep the second and the third day after surgery Quality of sleep will be evaluated with the Richards Campbell sleep questionnaire (RCSQ).
Postoperative pain within 3 days after surgery. Postoperative pain will be assessed with Numerical Rating Scale (NRS). Postoperative analgesia will be recorded.
Quality of recovery. First day after surgery Quality of recovery will be evaluated with 15-item quality of recovery questionnaire (QoR-15).
The severity of postoperative delirium. Postoperative 5 days The severity of postoperative delirium will be assessed by Delirium Rating Scale-Revised-98.
Cognitive function before surgery and 5 days after surgery Cognitive function will be assessed using the Mini-Mental State Examination (MMSE) and the Montreal cognitive assessment-basic (MoCA-B).
Anxiety and depression before surgery and 5 days after surgery Anxiety and depression will be evaluated using Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionaire-9 items (PHQ -9).
Parkinson's disease related status before surgery and 5 days after surgery Parkinson's disease related status will be evaluated by Movement Disorder Society-Sponsored Revision Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
Trial Locations
- Locations (1)
Beijing Tian Tan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China