ThyroidNCT04830293
Effect of Head Position During Thyroidectomy on Postoperative Cognitive Functions
An observational study of Thyroid and Carotid Doppler, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid, Carotid Doppler, Cerebral Perfusion
- What is being tested?
- Carotis Doppler Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 31 Dec 2020
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- undergo a total thyroidectomy operation
- ASA I-II
- euthyroid patients in the preoperative period
Who cannot join
- Hemoglobin< 8 g / dl
- Hypertension
- Hyperlipidemia
- Pregnancy
- Patients diagnosed with diabetes mellitus
- Cerebrovascular insufficiency
Show all 10Show fewer
- Known carotid artery lesion
- Metabolic diseases
- Any intracranial pathology present
- Surgeries exceeding 180 minutes
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University Medicine Faculty
Zonguldak, Kozlu, 67600
About this study
Official title: 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.
- Conditions
- Thyroid, Carotid Doppler, Cerebral Perfusion
- Being tested
- Carotis Doppler Ultrasound
- Keywords
- Head position, Cerebral Oxygenation, Postoperative Cognitive Dysfunction
- Medical subject headings
- Thyroid Diseases, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotis Doppler UltrasoundProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cognitive functions
determine cognitive dysfunction using mini mental state examination
Measured: 3 months after surgery
Secondary outcomes (1)
Changes in Cerebral Perfusion
Changes in main carotid artery blood flow and cerebral oxygenation by using carotid doppler
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Mar 2019
- Primary completion30 Oct 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bengü Gülhan Aydin, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830293
- Sponsor's protocol ID
- 2119-40-14/02
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 2021
- Last updated
- 5 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Head Position During Thyroidectomy on Cerebral Oxygenation and Postoperative Cognitive Functions
- ClinicalTrials.gov ID
- NCT04830293
- Acronym / sponsor ID
- 2119-40-14/02
- Conditions
- Thyroid, Carotid Doppler, Cerebral Perfusion
- Keywords
- Head position, Cerebral Oxygenation, Postoperative Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- undergo a total thyroidectomy operation
- ASA I-II
- euthyroid patients in the preoperative period
Key exclusion criteria (10 listed)
- Hemoglobin< 8 g / dl
- Hypertension
- Hyperlipidemia
- Pregnancy
- Patients diagnosed with diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotis Doppler UltrasoundNeck 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. | Procedure or surgery | – |
Primary outcome
Changes in cognitive functions
Time frame: 3 months after surgery
determine cognitive dysfunction using mini mental state examination
1 secondary outcome
Changes in Cerebral Perfusion
Time frame: during surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid and Carotid Doppler, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cognitive functions (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.