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

NCT05197439 | Unknown

• 1 other identifier: 20220106
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dexmedetomidine; Postoperative Delirium; Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The severity of postoperative delirium.

  Postoperative 5 days

• Postoperative pain

  within 3 days after surgery.

• Quality of recovery.

  First day after surgery

• Quality of sleep

  the second and the third day after surgery

• Cognitive function

  before surgery and 5 days after surgery

Study Arms (2)

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.

Drug: Dexmedetomidine

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.

Drug: 0.9% saline

Interventions

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.

DEX group

0.9% saline DRUG

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

Placebo group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Parkinson's Disease
• Exist non-motor symptoms
• Undergoing selective DBS.
• Age ≥60 years.
• Obtain written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100160, China

Location

Related Publications (1)

• 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.

  PMID: 37433729 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yuming Peng, MD,Ph.D

  Beijing Tian Tan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuming Peng, MD,Ph.D

CONTACT

8610-59976658; florapym766@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief of Department of Anesthesiology

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 19, 2022
• Study Start: December 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)