CompletedNot Applicable

Effect of Optıc Nerve Dıameter ın Tymphanoplasty Surgery Performed ın Lateral Head Posıtıon

Turkey (Türkiye)53 participantsStarted 2020-01-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial studied how lying with the head turned to the side during tympanoplasty affects intracranial pressure — can you explain whether that position during my ear surgery could raise my pressure, and how that might matter for my specific situation?
2The researchers used optic nerve diameter as a way to measure intracranial pressure changes — is that something that was monitored during my surgery or would be monitored if I have this procedure, and what would happen if a concern was detected?
3Since this trial is already completed, have the results changed any standard safety practices around head positioning during tympanoplasty, and should those findings influence how my surgical team plans my procedure?
4Are there any factors in my personal health history — like existing eye conditions, blood pressure issues, or prior head injuries — that would make me more vulnerable to the kind of intracranial pressure changes this trial was investigating?
5If the findings from this study suggest there are meaningful risks to intracranial pressure from the lateral head position, are there alternative positioning options or techniques my surgeon could use that might reduce that risk for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The effect of lateral head position on intracranial pressure

Timeframe: 2 years

Trial details

NCT IDNCT07407972

SponsorBursa Yuksek Ihtisas Training and Research Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2020-07-01

View on ClinicalTrials.gov More Optic Nerve Diameter trials