Back to resultsEffect of Dexmedetomidine on Postoperative Cognitive Function in Patients Undergoing Shoulder Arthroscopy With Beach Chair Position Under Desflurane Anesthesia
Primary Purpose
Rotator Cuff Tear
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Rotator Cuff Tear focused on measuring cognitive function, desflurane, dexmedetomidine
Eligibility Criteria
Inclusion Criteria:
1. Patients undergoing shoulder arthroscopic surgery with beach chair position
Exclusion Criteria:
- Patients with respiratory disease
- Patients with cardiac disease
- Patients with cerebrovascular disease
- patients with uncontrolled hypertension
- Patients with dementia
- Patients with psychiatric disease
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
normal saline
Dex
Arm Description
Outcomes
Primary Outcome Measures
Number of patients with postoperative cognitive decline assessed by mini-mental state examination
to compare cognitive decline after surgery between control and dexmedetomidine group with mini-mental state examination.
Number of patients with postoperative cognitive decline assessed by a battery of psychometric test
to compare cognitive decline after surgery between control and dexmedetomidine group with a battery of psychometric test. The battery consists of copy geometric form test, two-dimensional model test, grooved pegboard test, colored block design test, puzzle test, clock drawing test.
Secondary Outcome Measures
Number of patients with increase of S100ß protein after surgery assessed by ELISA assay with blood of patients
S100ß protein is the biologic marker for neuroinflammation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02643017
Brief Title
Effect of Dexmedetomidine on Postoperative Cognitive Function in Patients Undergoing Shoulder Arthroscopy With Beach Chair Position Under Desflurane Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 11, 2015 (Actual)
Primary Completion Date
August 16, 2018 (Actual)
Study Completion Date
August 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigate the effects of dexmedetomidine on postoperative cognitive function in patients undergoing shoulder arthroscopy with beach chair position under desflurane anesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
cognitive function, desflurane, dexmedetomidine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Title
Dex
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Administration of dexmedetomidine at a rate 0.6 ug/kg/hr during surgery.
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
Administration of same amount of dexmedetomidine at a rate 0.6 ug/kg/hr during surgery.
Primary Outcome Measure Information:
Title
Number of patients with postoperative cognitive decline assessed by mini-mental state examination
Description
to compare cognitive decline after surgery between control and dexmedetomidine group with mini-mental state examination.
Time Frame
from 1 day before surgery to postoperative 1 day
Title
Number of patients with postoperative cognitive decline assessed by a battery of psychometric test
Description
to compare cognitive decline after surgery between control and dexmedetomidine group with a battery of psychometric test. The battery consists of copy geometric form test, two-dimensional model test, grooved pegboard test, colored block design test, puzzle test, clock drawing test.
Time Frame
from 1 day before surgery to postoperative 1 day
Secondary Outcome Measure Information:
Title
Number of patients with increase of S100ß protein after surgery assessed by ELISA assay with blood of patients
Description
S100ß protein is the biologic marker for neuroinflammation
Time Frame
from 5 min after induction of anesthesia to an 1 hour after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1. Patients undergoing shoulder arthroscopic surgery with beach chair position
Exclusion Criteria:
Patients with respiratory disease
Patients with cardiac disease
Patients with cerebrovascular disease
patients with uncontrolled hypertension
Patients with dementia
Patients with psychiatric disease
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share the data.
Learn more about this trial
Effect of Dexmedetomidine on Postoperative Cognitive Function in Patients Undergoing Shoulder Arthroscopy With Beach Chair Position Under Desflurane Anesthesia
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