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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02643017
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 32.2
• Patients Per Site Per Month: 2.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tear	Drug: Dexmedetomidine; Drug: normal saline	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Actual Study Start Date: Dec 11, 2015
• Actual Primary Completion Date: Aug 16, 2018
• Actual Study Completion Date: Aug 16, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Number of patients with postoperative cognitive decline assessed by mini-mental state examination [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.

2. Number of patients with postoperative cognitive decline assessed by a battery of psychometric test [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.

Secondary Outcome Measures

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]

   S100ß protein is the biologic marker for neuroinflammation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine	Seoul		Korea, Republic of	03722

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02643017
• Other Study ID Numbers: 4-2015-0621
• First Posted: Dec 30, 2015
• Last Update Posted: Jan 25, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Yonsei University: cognitive function; desflurane; dexmedetomidine
• Additional relevant MeSH terms: Rotator Cuff Injuries; Dexmedetomidine

Study Results

No Results Posted as of Jan 25, 2019