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The Mechanism of Dexmedetomidine in Improving Delirium After Cardiac Surgery

Primary Purpose

Dexmedetomidine, Delirium, Cardiac Surgery

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
dexmedetomidine
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dexmedetomidine

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ICU patients underwent cardiac surgery
  • age ≥ 60 years

Exclusion Criteria:

  • Preoperative cognitive decline, mental illness,
  • preoperative long-term use of hormone patients,
  • preoperative alcohol dependence,
  • patients with alcohol withdrawal symptoms

Sites / Locations

  • Nanjing First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DEX group

control group

Arm Description

use DEX

use placebo

Outcomes

Primary Outcome Measures

delirium incidence
α7nAChR level

Secondary Outcome Measures

mechanical ventilation time
ICU stay time

Full Information

First Posted
October 12, 2019
Last Updated
October 12, 2019
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04127500
Brief Title
The Mechanism of Dexmedetomidine in Improving Delirium After Cardiac Surgery
Official Title
The Mechanism of Dexmedetomidine in Improving Delirium After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
August 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators aim to evaluate the roles of α7nAchR in the mechanisms of dexmedetomidine in improving delirium after cardiac surgery. The results of this study would lay the foundation for revealing the mechanisms of dexmedetomidine improving delirium after cardiac surgery and provide a new idea to the early treatment of delirium.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexmedetomidine, Delirium, Cardiac Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DEX group
Arm Type
Experimental
Arm Description
use DEX
Arm Title
control group
Arm Type
No Intervention
Arm Description
use placebo
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Intervention Description
dexmedetomidine
Primary Outcome Measure Information:
Title
delirium incidence
Time Frame
1 month
Title
α7nAChR level
Time Frame
7 days
Secondary Outcome Measure Information:
Title
mechanical ventilation time
Time Frame
7 days
Title
ICU stay time
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ICU patients underwent cardiac surgery age ≥ 60 years Exclusion Criteria: Preoperative cognitive decline, mental illness, preoperative long-term use of hormone patients, preoperative alcohol dependence, patients with alcohol withdrawal symptoms
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiankun Shi, Doctor
Phone
+8613851420762
Email
hlblade@gmail.com
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Zhou, master
Phone
+8613913893984
Email
565219791@qq.com
First Name & Middle Initial & Last Name & Degree
Liang Hong, master
First Name & Middle Initial & Last Name & Degree
Qiankun Shi, doctor

12. IPD Sharing Statement

Plan to Share IPD
No

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The Mechanism of Dexmedetomidine in Improving Delirium After Cardiac Surgery

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