- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07298187
The Effect of Head Position on the Optik Nerve Sheath Diameter in Patients During Thyroid Surgery
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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FATİH
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Istanbul, FATİH, Turkey (Türkiye), 34000
- Istanbul University Cerrahpasa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
OPTİC NERVE SHEATH DİAMETER
Time Frame: INTRAOPERATİVE PERİOD(FROM İNDUCTİON TO THE END OF SURGERY)
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CHANGE İN OPTİC NERVE SHEATH DİAMETER MEASURED BY ULTRASOUND BEFORE AND AFTER POSİTİONİNG DURİNG THYROİDECTOMY
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INTRAOPERATİVE PERİOD(FROM İNDUCTİON TO THE END OF SURGERY)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
POSTOPERATİVE HEADACHE SEVERİTY (VISUAL ANALOG SCALE)
Time Frame: WİTHİN SEVEN DAYS AFTER SURGERY
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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.
|
WİTHİN SEVEN DAYS AFTER SURGERY
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1274724
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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