Effect of Head Position During Thyroidectomy on Postoperative Cognitive Functions

Sponsor

Zonguldak Bulent Ecevit University (Other)

Overall Status

Completed

CT.gov ID

NCT04830293

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of our study is to observe the effect of head-neck position of patients scheduled for thyroidectomy, on carotid artery blood flow, regional cerebral oxygen saturation measured using near-infrared spectroscopy technology, and postoperative cognitive dysfunction.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Carotid Doppler Cerebral Perfusion	Procedure: Carotis Doppler Ultrasound

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Effect of Head Position During Thyroidectomy on Cerebral Oxygenation and Postoperative Cognitive Functions

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Oct 30, 2020

Actual Study Completion Date :

Dec 31, 2020

Outcome Measures

Primary Outcome Measures

Changes in cognitive functions [3 months after surgery]
determine cognitive dysfunction using mini mental state examination

Secondary Outcome Measures

Changes in Cerebral Perfusion [during surgery]
Changes in main carotid artery blood flow and cerebral oxygenation by using carotid doppler

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

undergo a total thyroidectomy operation
ASA I-II
euthyroid patients in the preoperative period

Exclusion Criteria:

Hemoglobin< 8 g / dl
Hypertension
Hyperlipidemia
Pregnancy
Patients diagnosed with diabetes mellitus
Cerebrovascular insufficiency
Known carotid artery lesion
Metabolic diseases
Any intracranial pathology present
Surgeries exceeding 180 minutes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zonguldak Bülent Ecevit University Medicine Faculty	Zonguldak	Kozlu	Turkey	67600

Sponsors and Collaborators

Zonguldak Bulent Ecevit University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bengü Gülhan Aydin, associate professor doctor, Zonguldak Bulent Ecevit University

ClinicalTrials.gov Identifier:

NCT04830293

Other Study ID Numbers:

2119-40-14/02

First Posted:

Apr 5, 2021

Last Update Posted:

Apr 5, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bengü Gülhan Aydin, associate professor doctor, Zonguldak Bulent Ecevit University

Head position

Cerebral Oxygenation

Postoperative Cognitive Dysfunction

Study Results

No Results Posted as of Apr 5, 2021