Dexmedetomidine Prevents Postoperative Delirium After Deep Brain Stimulation in Patients With Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Dexmedetomidine Postoperative Delirium Deep Brain Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

0.9% saline

Intervention Type DRUG

The 0.9% saline is administered with the same volume at the same speed as the other group.

DEX group

Dexmedetomidine will be given at the beginning of the second step of DBS and last for 48 hours by electronic pump.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type 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.

Interventions

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Dexmedetomidine

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.

Intervention Type DRUG

0.9% saline

The 0.9% saline is administered with the same volume at the same speed as the other group.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No