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

Primary Purpose

Dexmedetomidine, Postoperative Delirium, Deep Brain Stimulation

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
0.9% saline
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dexmedetomidine

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beijing Tian Tan Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

DEX group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The severity of postoperative delirium.
The severity of postoperative delirium will be assessed by Delirium Rating Scale-Revised-98.
Postoperative pain
Postoperative pain will be assessed with Numerical Rating Scale (NRS). Postoperative analgesia will be recorded.
Quality of recovery.
Quality of recovery will be evaluated with 15-item quality of recovery questionnaire (QoR-15).
Quality of sleep
Quality of sleep will be evaluated with the Richards Campbell sleep questionnaire (RCSQ).
Cognitive function
Cognitive function will be assessed using the Mini-Mental State Examination (MMSE) and the Montreal cognitive assessment-basic (MoCA-B).
Anxiety and depression
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
Parkinson's disease related status will be evaluated by Movement Disorder Society-Sponsored Revision Unified Parkinson's Disease Rating Scale (MDS-UPDRS).

Full Information

First Posted
January 5, 2022
Last Updated
June 13, 2023
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05197439
Brief Title
Dexmedetomidine Prevents Postoperative Delirium After Deep Brain Stimulation in Patients With Parkinson's Disease
Official Title
Effect of Dexmedetomidine on Postoperative Delirium in Elderly Patients With Parkinson's Disease Undergoing Deep Brain Stimulation: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexmedetomidine, Postoperative Delirium, Deep Brain Stimulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DEX group
Arm Type
Active Comparator
Arm Description
Dexmedetomidine will be given at the beginning of the second step of DBS and last for 48 hours by electronic pump.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The placebo group patients will be received 0.9% saline intraoperatively and postoperatively the same duration just like the DEX group would do.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
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
Intervention Name(s)
0.9% saline
Intervention Description
The 0.9% saline is administered with the same volume at the same speed as the other group.
Primary Outcome Measure Information:
Title
The incidence of postoperative delirium.
Description
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.
Time Frame
Postoperative 5 days
Secondary Outcome Measure Information:
Title
The severity of postoperative delirium.
Description
The severity of postoperative delirium will be assessed by Delirium Rating Scale-Revised-98.
Time Frame
Postoperative 5 days
Title
Postoperative pain
Description
Postoperative pain will be assessed with Numerical Rating Scale (NRS). Postoperative analgesia will be recorded.
Time Frame
within 3 days after surgery.
Title
Quality of recovery.
Description
Quality of recovery will be evaluated with 15-item quality of recovery questionnaire (QoR-15).
Time Frame
First day after surgery
Title
Quality of sleep
Description
Quality of sleep will be evaluated with the Richards Campbell sleep questionnaire (RCSQ).
Time Frame
the second and the third day after surgery
Title
Cognitive function
Description
Cognitive function will be assessed using the Mini-Mental State Examination (MMSE) and the Montreal cognitive assessment-basic (MoCA-B).
Time Frame
before surgery and 5 days after surgery
Title
Anxiety and depression
Description
Anxiety and depression will be evaluated using Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionaire-9 items (PHQ -9).
Time Frame
before surgery and 5 days after surgery
Title
Parkinson's disease related status
Description
Parkinson's disease related status will be evaluated by Movement Disorder Society-Sponsored Revision Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
Time Frame
before surgery and 5 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuming Peng, MD,Ph.D
Phone
8610-59976658
Email
florapym766@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuming Peng, MD,Ph.D
Organizational Affiliation
Beijing Tian Tan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tian Tan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100160
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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