Deep Brain Stimulation, Dexmedetomidine, Postoperative Delirium
Conditions
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.
Interventions
DRUGDexmedetomidine
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.
DRUG0.9% saline
The 0.9% saline is administered with the same volume at the same speed as the other group.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Quality of sleep | the second and the third day after surgery | Quality of sleep will be evaluated with the Richards Campbell sleep questionnaire (RCSQ). |
| The severity of postoperative delirium. | Postoperative 5 days | The severity of postoperative delirium will be assessed by Delirium Rating Scale-Revised-98. |
| 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). |
| 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). |
Countries
China
Contacts
Primary ContactYuming Peng, MD,Ph.D
Outcome results
None listed