Thyroid CancerNCT07298187
The Effect of Head Position on the Optik Nerve Sheath Diameter in Patients During Thyroid Surgery
An observational study of Thyroid Cancer and Thyroid and Parathyroid Surgery, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
THE EFFECT OF HEAD POSİTİON ON THE OPTİC NERVE SHEATH DİAMETER İN PATİENTS DURİNG THYROİD SURGERY Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Cancer, Thyroid and Parathyroid Surgery, Thyroid Adenoma
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 3 Nov 2025
- How long will I take part?
- 7 Days
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ISTANBUL UNIVERSITY-CERRAHPASA
Who may be able to join
- Patients aged between 18 and 65, with an ASA score between 1 and 2 according to the American Society of Anesthesiologists (ASA) physical status classification system
- whose surgery duration was expected to be less than 4 hours were included in our study.
Who cannot join
- liver failure
- kidney failure
- intracranial masses
- history of hydrocephalus,
- migraine
- chronic hypoxemia or hypercarbic lung disease
Show all 16Show fewer
- additional heart disease
- hemodynamic insufficiency
- neurological and psychiatric diseases,
- glaucoma
- patients in whom ocular USG could not provide adequate images
- patients with pathological problems involving the eyelid and its surrounding area
- patients with diseases such as periorbital cellulitis
- patients with preoperative headache complaints
- patients with known diseases that could cause increased intracranial pressure
- patients who refused to participate in the study were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa
Istanbul, FATİH, 34000
About this study
THE EFFECT OF HEAD POSİTİON ON THE OPTİC NERVE SHEATH DİAMETER İN PATİENTS DURİNG THYROİD SURGERY
Read the detailed description
Aim: In thyroidectomy surgery, the patient's head is placed in hyperextension and the patient is placed in a semi-sitting position to facilitate access to the surgical site. This position of the head causes a decrease in venous return or partial obstruction of venous return due to stretching of the neck veins. The aim of our study is to demonstrate the effect of surgical position on intracranial pressure by measuring the optic nerve sheath diameter (OSSD) using ultrasonography in patients undergoing thyroid surgery and to determine its correlation with post-operative headaches.
Material And Method: Our study was conducted prospectively and randomly in patients undergoing elective total thyroidectomy. Patients aged 18-65 with an ASA score of 1-2 and an operation time of less than 4 hours were included in our study. Patients were positioned in the semi-Fowler position with a 30° extension of the head. Bilateral OSSD surgical positioning was applied, and after ensuring haemodynamic stability for 5 minutes and at the end of the operation, measurements were taken twice using ultrasound, and the average was recorded. The Visual Analogue Scale (VAS) was used to assess postoperative pain intensity. Headache was assessed and recorded at 15 minutes, 30 minutes, 1 hour, 24 hours, 3 days, and 7 days postoperatively.
- Medical subject headings
- Thyroid Neoplasms, Thyroid Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
OPTİC NERVE SHEATH DİAMETER
CHANGE İN OPTİC NERVE SHEATH DİAMETER MEASURED BY ULTRASOUND BEFORE AND AFTER POSİTİONİNG DURİNG THYROİDECTOMY
Measured: INTRAOPERATİVE PERİOD(FROM İNDUCTİON TO THE END OF SURGERY)
Secondary outcomes (1)
POSTOPERATİVE HEADACHE SEVERİTY (VISUAL ANALOG SCALE)
THE SEVERİTY OF POSTOPERATİVE HEADACHE WİLL BE ASSESSED USİNG A VİSUAL ANALOG SCALE. THE LOWEST POSSIBLE SCORE ON THE VISUAL ANALOG SCALE WAS 0, AND THE HIGHEST POSSIBLE SCORE WAS 10.
Measured: WİTHİN SEVEN DAYS AFTER SURGERY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Apr 2025
- Primary completion30 Sep 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziya Kayadurmuş, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298187
- Sponsor's protocol ID
- 1274724
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: THE INDIVIDUAL PARTİCİPANT DATA WİLL NOT BE SHARED BECAUSE OF İNSTİTUTİONAL AND ETHİCAL RESTRİCTİONS
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Head Position on the Optik Nerve Sheath Diameter in Patients During Thyroid Surgery
- ClinicalTrials.gov ID
- NCT07298187
- Acronym / sponsor ID
- 1274724
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 23 Dec 2025 (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 EFFECT OF HEAD POSİTİON ON THE OPTİC NERVE SHEATH DİAMETER İN PATİENTS DURİNG THYROİD SURGERY
Detailed description
Aim: In thyroidectomy surgery, the patient's head is placed in hyperextension and the patient is placed in a semi-sitting position to facilitate access to the surgical site. This position of the head causes a decrease in venous return or partial obstruction of venous return due to stretching of the neck veins. The aim of our study is to demonstrate the effect of surgical position on intracranial pressure by measuring the optic nerve sheath diameter (OSSD) using ultrasonography in patients undergoing thyroid surgery and to determine its correlation with post-operative headaches.
Material And Method: Our study was conducted prospectively and randomly in patients undergoing elective total thyroidectomy. Patients aged 18-65 with an ASA score of 1-2 and an operation time of less than 4 hours were included in our study. Patients were positioned in the semi-Fowler position with a 30° extension of the head. Bilateral OSSD surgical positioning was applied, and after ensuring haemodynamic stability for 5 minutes and at the end of the operation, measurements were taken twice using ultrasound, and the average was recorded. The Visual Analogue Scale (VAS) was used to assess postoperative pain intensity. Headache was assessed and recorded at 15 minutes, 30 minutes, 1 hour, 24 hours, 3 days, and 7 days postoperatively.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ISTANBUL UNIVERSITY-CERRAHPASA
Key inclusion criteria (2 listed)
- Patients aged between 18 and 65, with an ASA score between 1 and 2 according to the American Society of Anesthesiologists (ASA) physical status classification system
- whose surgery duration was expected to be less than 4 hours were included in our study.
Key exclusion criteria (16 listed)
- liver failure
- kidney failure
- intracranial masses
- history of hydrocephalus,
- migraine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
OPTİC NERVE SHEATH DİAMETER
Time frame: INTRAOPERATİVE PERİOD(FROM İNDUCTİON TO THE END OF SURGERY)
CHANGE İN OPTİC NERVE SHEATH DİAMETER MEASURED BY ULTRASOUND BEFORE AND AFTER POSİTİONİNG DURİNG THYROİDECTOMY
1 secondary outcome
POSTOPERATİVE HEADACHE SEVERİTY (VISUAL ANALOG SCALE)
Time frame: WİTHİN SEVEN DAYS AFTER 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 23 Dec 2025.
- Individual participant dataSharing planned: No. THE INDIVIDUAL PARTİCİPANT DATA WİLL NOT BE SHARED BECAUSE OF İNSTİTUTİONAL AND ETHİCAL RESTRİCTİONS
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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 Cancer and Thyroid and Parathyroid Surgery, run by Istanbul University - Cerrahpasa 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 2 inclusion and 16 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 23 Dec 2025. 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?
OPTİC NERVE SHEATH DİAMETER (time frame: INTRAOPERATİVE PERİOD(FROM İNDUCTİON TO THE END OF 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 23 Dec 2025.