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

NCT02643017 | Completed

• 1 other identifier: 4-2015-0621
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rotator Cuff Tear

Keywords

cognitive function; desflurane; dexmedetomidine

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Number of patients with increase of S100ß protein after surgery assessed by ELISA assay with blood of patients

  from 5 min after induction of anesthesia to an 1 hour after surgery

Study Arms (2)

normal saline

PLACEBO COMPARATOR

Drug: normal saline

Dex

EXPERIMENTAL

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Administration of dexmedetomidine at a rate 0.6 ug/kg/hr during surgery.

Dex

normal saline DRUG

Administration of same amount of dexmedetomidine at a rate 0.6 ug/kg/hr during surgery.

normal saline

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients undergoing shoulder arthroscopic surgery with beach chair position

You may not qualify if:

• Patients with respiratory disease
• Patients with cardiac disease
• Patients with cerebrovascular disease
• patients with uncontrolled hypertension
• Patients with dementia
• Patients with psychiatric disease

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 30, 2015
• Study Start: December 11, 2015
• Primary Completion: August 16, 2018
• Study Completion: August 16, 2018
• Last Updated: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)