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

Overview

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.

Full Title of Study: “Effect of Dexmedetomidine on Postoperative Delirium in Elderly Patients With Parkinson’s Disease Undergoing Deep Brain Stimulation: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 30, 2024

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: DEX group
    • Dexmedetomidine will be given at the beginning of the second step of DBS and last for 48 hours by electronic pump.
  • Placebo Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • The incidence of postoperative delirium.
    • Time Frame: Postoperative 5 days
    • 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.

Secondary Measures

  • The severity of postoperative delirium.
    • Time Frame: Postoperative 5 days
    • The severity of postoperative delirium will be assessed by Delirium Rating Scale-Revised-98.
  • Postoperative pain
    • Time Frame: within 3 days after surgery.
    • Postoperative pain will be assessed with Numerical Rating Scale (NRS). Postoperative analgesia will be recorded.
  • Quality of recovery.
    • Time Frame: First day after surgery
    • Quality of recovery will be evaluated with 15-item quality of recovery questionnaire (QoR-15).
  • Quality of sleep
    • Time Frame: the second and the third day after surgery
    • Quality of sleep will be evaluated with the Richards Campbell sleep questionnaire (RCSQ).
  • Cognitive function
    • Time Frame: before surgery and 5 days after surgery
    • Cognitive function will be assessed using the Mini-Mental State Examination (MMSE) and the Montreal cognitive assessment-basic (MoCA-B).
  • Anxiety and depression
    • Time Frame: before surgery and 5 days after surgery
    • Anxiety and depression will be evaluated using Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionaire-9 items (PHQ -9).
  • Parkinson’s disease related status
    • Time Frame: before surgery and 5 days after surgery
    • Parkinson’s disease related status will be evaluated by Movement Disorder Society-Sponsored Revision Unified Parkinson’s Disease Rating Scale (MDS-UPDRS).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beijing Tiantan Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yuming Peng, Deputy chief of Department of Anesthesiology – Beijing Tiantan Hospital
  • Overall Official(s)
    • Yuming Peng, MD,Ph.D, Principal Investigator, Beijing Tian Tan Hospital
  • Overall Contact(s)
    • Yuming Peng, MD,Ph.D, 8610-59976658, florapym766@163.com

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