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

January 23, 2019 updated by: Yonsei University
Investigate the effects of dexmedetomidine on postoperative cognitive function in patients undergoing shoulder arthroscopy with beach chair position under desflurane anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: normal saline
Drug: normal saline
Administration of same amount of dexmedetomidine at a rate 0.6 ug/kg/hr during surgery.
Experimental: Dex
Drug: Dexmedetomidine
Administration of dexmedetomidine at a rate 0.6 ug/kg/hr during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with postoperative cognitive decline assessed by mini-mental state examination
Time Frame: from 1 day before surgery to postoperative 1 day
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
Number of patients with postoperative cognitive decline assessed by a battery of psychometric test
Time Frame: from 1 day before surgery to postoperative 1 day
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with increase of S100ß protein after surgery assessed by ELISA assay with blood of patients
Time Frame: from 5 min after induction of anesthesia to an 1 hour after surgery
S100ß protein is the biologic marker for neuroinflammation
from 5 min after induction of anesthesia to an 1 hour after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2015

Primary Completion (Actual)

August 16, 2018

Study Completion (Actual)

August 16, 2018

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

December 28, 2015

First Posted (Estimate)

December 30, 2015

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 23, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2015-0621

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan to share the data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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