NCT04830293

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
Last Updated

April 5, 2021

Status Verified

April 1, 2021

Enrollment Period

1.7 years

First QC Date

March 30, 2021

Last Update Submit

April 1, 2021

Conditions

Keywords

Head positionCerebral OxygenationPostoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Changes in cognitive functions

    determine cognitive dysfunction using mini mental state examination

    3 months after surgery

Secondary Outcomes (1)

  • Changes in Cerebral Perfusion

    during surgery

Interventions

Neck was rotated about 30-45 ° to the opposite side of the image. The common carotid artery and internal jugular vein were viewed transversely on the B Mode USG image. Then, the probe was rotated approximately 90 ° and the carotid artery was visualized in the longitudinal plane. The probe and guide line were adjusted so that the Doppler angle was 60 °. The image was created with the guiding line parallel to the blood flow. After imaging of the carotid artery bifurcation, measurements were made 1 cm distal to this level.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Thyroid DiseasesPostoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Endocrine System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor doctor

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 5, 2021

Study Start

March 1, 2019

Primary Completion

October 30, 2020

Study Completion

December 31, 2020

Last Updated

April 5, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations