Anesthesia, Parkinson Disease
Conditions
Keywords
Parkinson's disease, UPDRS-III, Deep Brain Stimulation, MAC, AAA
Brief summary
Compares the patients' scores of UPDRS-III before and six-month after receiving deep brain stimulation for Parkinson's disease under MAC or AAA anesthesia.
Detailed description
Compares the patients' scores of UPDRS-III before and six-month after receiving deep brain stimulation for Parkinson's disease under MAC or AAA anesthesia. Besides, the research also compares the adverse events, LED, dosage of anesthetic drugs, wake-up time, surgical time, Hoehn&Yahr, PQD-39, MMSE, MoCA, HAMA, HAMD and patients' satisfaction between the two groups mentioned above.
Interventions
PROCEDUREMAC anesthesia
Patients receives DBS under monitored anesthesia care.
PROCEDUREAAA anesthesia
Patients receives DBS under asleep-awake-asleep anesthesia.
Sponsors
Shenzhen Second People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than 18 years old * Diagnosis of primary Parkinson's disease * Parkinson's disease-related symptoms remain difficult to control with appropriate anti-parkinsonian medications.
Exclusion criteria
* Refusal to Participate in the research * Patients with severe comorbidities such as severe sleep apnea syndrome and metal disorder * Previous functional neurosurgery: DBS, thalamic incision, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scores' change of Unified Parkinson's Rating Scale (part III/motor part) | Before and six-month after DBS. | Compares the scores' change of Unified Parkinson's Rating Scale (part III/motor part) between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scores' change of Montreal Cognitive Assessment | Before and six-month after DBS. | Compares the scores' change of Montreal Cognitive Assessment between the two groups. |
| Change of Levodopa Equivalent Dose | Before and six-month after DBS. | Compares the change of Levodopa equivalent dose between the two groups. |
| Rates of Adverse Events | Intra-operative. | Compares the rates of adverse events between the two groups. |
| Dosage of Anesthetic Drugs | Within surgery. | Compares the dosage of anesthetic between the two groups. |
| Wake-up Time | Within surgery. | Compares the wake-up time between the two groups. |
| Scores' change of Mini-mental State Examination | Before and six-month after DBS. | Compares the scores' change of Mini-mental State Examination between the two groups. |
| Hoehn&Yahr | Before surgery. | Compares the Hoehn&Yahr classification between the two groups' patients. |
| Patients' Satisfaction(Visual Analogue Scale) | 24 hours after surgery. | Compares the scores of patients' satisfaction between the two groups' patients by Using a visual analogue scale. The minimum value is 0 and maximum value is 10. Higher value means greater satisfaction. |
| Scores' change of 39-item Parkinson's Disease Questionnaire | Before and six-month after DBS. | Compares the scores' change of 39-item Parkinson's Disease Questionnaire between the two groups. |
| Scores' change of Hamilton Anxiety Scale | Before and six-month after DBS. | Compares the scores' change of Hamilton Anxiety Scale between the two groups. |
| Scores' change of Hamilton Depression Scale | Before and six-month after DBS. | Compares the scores' change of Hamilton Depression Scale between the two groups. |
| Surgical Time | Within surgery. | Compares the surgical time between the two groups. |
Countries
China
Outcome results
None listed