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NCT02643017 Clinical Trial

Effect of Dexmedetomidine on Postoperative Cognitive Function in Patients Undergoing Shoulder Arthroscopy With Beach Chair Position Under Desflurane Anesthesia

Rotator Cuff Tear Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02643017
Other study ID # 4-2015-0621
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 11, 2015
Est. completion date August 16, 2018

Study information
Verified date January 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigate the effects of dexmedetomidine on postoperative cognitive function in patients undergoing shoulder arthroscopy with beach chair position under desflurane anesthesia.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date August 16, 2018
Est. primary completion date August 16, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

1. Patients undergoing shoulder arthroscopic surgery with beach chair position

Exclusion Criteria:

1. Patients with respiratory disease

2. Patients with cardiac disease

3. Patients with cerebrovascular disease

4. patients with uncontrolled hypertension

5. Patients with dementia

6. Patients with psychiatric disease

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dexmedetomidine
Administration of dexmedetomidine at a rate 0.6 ug/kg/hr during surgery.
• normal saline
Administration of same amount of dexmedetomidine at a rate 0.6 ug/kg/hr during surgery.

Locations
Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. from 1 day before surgery to postoperative 1 day
Primary 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. from 1 day before surgery to postoperative 1 day
Secondary 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 from 5 min after induction of anesthesia to an 1 hour after surgery
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