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Completed

NCT Number: NCT07407972

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa yüksek ihtisas eğitim ve araştırma hastanesi BURSA, Bursa, Türkiye

Bursa, 26000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

optic nerve diameter

Diagnostic Test

optic nerve diameter measurement

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

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

Acronym: ONSD

Important dates

Study start
2020
Primary completion
2020
Study completion
2025
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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