- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07407972
Effect of Optıc Nerve Dıameter ın Tymphanoplasty Surgery Performed ın Lateral Head Posıtıon (ONSD)
February 10, 2026 updated by: sermın emınoglu, Bursa Yuksek Ihtisas Training and Research Hospital
Effect of Optıc Nerve Dıameter ın Tymphanoplasty Surgery Performed ın Lateral Head Posıtıon Under General Anesthesia
Studies exist to determine the effect of laparoscopic surgical procedures on increased intra-abdominal pressure; these studies include optic nerve sheath diameter (ONSD) measurement in various positions such as trendelenburg and prone, and the effect of the laryngoscope used in intubation on increased intracranial pressure.
In these situations, changes in cerebral blood flow and intracranial pressure may occur due to impaired neck venous return.
There are no studies in the literature regarding increased osd and consequently increased intracranial pressure in lateral head position.ultrasound
for ONSD measurement is a non-invasive, rapid, and easily applicable method for diagnosing changes in intracranial pressure.
In tympanoplasty surgeries, the head and neck remain in a lateral position, and venous return in the surgical field may sometimes be compressed due to the procedure.
The aim of this study is to determine the effect of lateral head position and variables such as demographic data and surgical duration on increased intracranial pressure.
Methods: Patients over 18 years of age, classified as asa ı and ıı, undergoing tympanoplasty surgery under general anesthesia in the lateral head and neck position will be included in the study.
Patients' vital signs (arterial blood pressure, heart rate, spo2, and etco2) will be monitored regularly in the operating room before and after surgery.
Demographic data (age, gender, weight, height), surgery duration, and postoperative complications will also be recorded.
Anesthesia will be administered with 2-4 mg/kg propofol, 0.6 mg/kg rocuronium, and 1-2 mcg/kg fentanyl for induction, and sevoflurane for maintenance.
Following intubation, onstitial lateral head and neck (onsd) measurements will be taken by the anesthesiologist at three time intervals (in transverse and sagittal planes).
Both onsds will be recorded by ultrasound: T1: 5 minutes in the supine position, T2: at the end of the procedure with the head in the lateral position, and T3: before extubation in the supine position.
Postoperative headache and neck pain will be inquired about after waking up and at 1., 6., and 24.
hours later.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bursa
-
Bursa, Bursa, Turkey (Türkiye), 26000
- Bursa yüksek ihtisas eğitim ve araştırma hastanesi BURSA, Bursa, Türkiye
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Patients over 18 years of age Patients undergoing tympanoplasty surgery under general anesthesia Patients with ASA I or II Patients scheduled for surgery in the lateral head and neck position
Exclusion Criteria:
- Patients who will have neck dissection,
- Patients who have undergone other procedures that may cause changes in -intracranial pressure,
- Patients under 18 years of age,
- Patients who cannot communicate,
- Patients with glaucoma and eye disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: ONSD Measurement
ONSD measurements were taken in three time intervals by the anesthesiologist: transverse and sagittal planes.
Both ONSDs were recorded by ultrasound at T1: 5 min in supine position, T2: end of the procedure with head in lateral position, and T3: supine position before extubation.
|
optic nerve diameter measurement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The effect of lateral head position on intracranial pressure
Time Frame: 2 years
|
The effect of lateral head positioning on intracranial pressure will be determined by measuring the diameter of the optic nerve sheath under ultrasound guidance.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Actual)
July 1, 2020
Study Completion (Actual)
June 1, 2025
Study Registration Dates
First Submitted
January 29, 2026
First Submitted That Met QC Criteria
February 10, 2026
First Posted (Actual)
February 12, 2026
Study Record Updates
Last Update Posted (Actual)
February 12, 2026
Last Update Submitted That Met QC Criteria
February 10, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Stomatognathic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Infections
- Infections
- Respiratory Tract Diseases
- Otorhinolaryngologic Diseases
- Pharyngeal Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Headache
- Intracranial Hypertension
- Pharyngitis
Other Study ID Numbers
- 2011-KAEK-25 2020/01-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The study protocol and results can be shared.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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