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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEX group | Active Comparator | Dexmedetomidine will be given at the beginning of the second step of DBS and last for 48 hours by electronic pump. |
|
| Placebo group | Placebo Comparator | The placebo group patients will be received 0.9% saline intraoperatively and postoperatively the same duration just like the DEX group would do. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 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. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuming Peng, MD,Ph.D | Contact | 8610-59976658 | florapym766@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuming Peng, MD,Ph.D | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tian Tan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100160 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37433729 | Derived | Yao J, Shen Z, Jin H, Ma T, Wang J, Li S, Zeng M, Liu X, Peng Y. Dexmedetomidine after deep brain stimulation for prevention of delirium in elderly patients with Parkinson's disease: protocol for a single-centre, randomised, double-blind, placebo-controlled trial in China. BMJ Open. 2023 Jul 11;13(7):e070185. doi: 10.1136/bmjopen-2022-070185. |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 0.9% saline | Drug | The 0.9% saline is administered with the same volume at the same speed as the other group. |
|
| 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 |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |