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

Capital Medical University

Status: Not yet enrolling

Conditions: Dexmedetomidine; Deep Brain Stimulation; Postoperative Delirium

Treatments: Drug: Dexmedetomidine; Drug: 0.9% saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05197439

20220106

Details and patient eligibility

About

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.

Enrollment: 192 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

192 participants in 2 patient groups, including a placebo group

DEX group

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine

Placebo group

Placebo Comparator group

Description:

The placebo group patients will be received 0.9% saline intraoperatively and postoperatively the same duration just like the DEX group would do.

Treatment:

Drug: 0.9% saline