Effect of Head Position During Thyroidectomy on Postoperative Cognitive Functions

April 1, 2021 updated by: Bengü Gülhan Aydin, Zonguldak Bulent Ecevit University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

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

  • Turkey
    • Kozlu
      • Zonguldak, Kozlu, Turkey, 67600
        • Zonguldak Bülent Ecevit University Medicine Faculty

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients between the ages of 18-50 who will undergo total thyroidectomy under general anesthesia due to elective thyroid cancer, Hashimoto's thyroiditis or thyrotoxicosis, in the American Society of Anesthesiologists (ASA) I-II risk group, who are euthyroid in the preoperative period

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in cognitive functions
Time Frame: 3 months after surgery
determine cognitive dysfunction using mini mental state examination
3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Cerebral Perfusion
Time Frame: during surgery
Changes in main carotid artery blood flow and cerebral oxygenation by using carotid doppler
during surgery

Collaborators and Investigators

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

Sponsor

Zonguldak Bulent Ecevit 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)

March 1, 2019

Primary Completion (Actual)

October 30, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

March 30, 2021

First Submitted That Met QC Criteria

April 1, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 5, 2021

Last Update Submitted That Met QC Criteria

April 1, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2119-40-14/02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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