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

Postoperative Delirium Clinical Trial

Official title:

Effect of Dexmedetomidine on Postoperative Delirium in Elderly Patients With Parkinson's Disease Undergoing Deep Brain Stimulation: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05197439
• Other study ID #: 20220106
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Beijing Tiantan Hospital
• Contact: Yuming Peng, MD,Ph.D
• Phone: 8610-59976658
• Email: florapym766[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 192
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Delirium
• Dexmedetomidine
• Emergence Delirium
• Parkinson Disease
• Postoperative Delirium

Intervention

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

Locations

Country	Name	City	State
China	Beijing Tian Tan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	The severity of postoperative delirium.	The severity of postoperative delirium will be assessed by Delirium Rating Scale-Revised-98.	Postoperative 5 days
Secondary	Postoperative pain	Postoperative pain will be assessed with Numerical Rating Scale (NRS). Postoperative analgesia will be recorded.	within 3 days after surgery.
Secondary	Quality of recovery.	Quality of recovery will be evaluated with 15-item quality of recovery questionnaire (QoR-15).	First day after surgery
Secondary	Quality of sleep	Quality of sleep will be evaluated with the Richards Campbell sleep questionnaire (RCSQ).	the second and the third day after surgery
Secondary	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
Secondary	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
Secondary	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