The Effect of Head Position on the Optik Nerve Sheath Diameter in Patients During Thyroid Surgery

NCT ID: NCT07298187

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-11-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

THE EFFECT OF HEAD POSİTİON ON THE OPTİC NERVE SHEATH DİAMETER İN PATİENTS DURİNG THYROİD SURGERY

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thyroid Cancer Thyroid and Parathyroid Surgery Thyroid Adenoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* liver failure
* kidney failure
* intracranial masses
* history of hydrocephalus,
* migraine
* chronic hypoxemia or hypercarbic lung disease
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ziya Kayadurmuş

RESEARCH ASSİSTANT DOCTOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul University Cerrahpasa

Istanbul, FATİH, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1274724

Identifier Type: -

Identifier Source: org_study_id