ClinicalTrials.gg
CompletedNCT07407972ONSDUpdated Feb 12, 2026

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

An interventional study of optic nerve diameter in Optic Nerve Diameter and Intracranial Pressure Increase, sponsored by Bursa Yuksek Ihtisas Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by Bursa Yuksek Ihtisas Training and Research Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 6 years after the study started (first participant enrolled Jan 2020, registered Jan 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Optic Nerve Diameter
  • Intracranial Pressure Increase

Keywords

  • tympanoplasty
  • lateral position
  • optic nerve diameter
  • intracranial pressure
  • headache and sore throat
03

In context

Intracranial Hypertension

165 studies on the registry are indexed under Intracranial Hypertension; 36 are open to participants now.

This study's enrollment of 53 is close to the median of 50 across 81 interventional studies indexed under Intracranial Hypertension.

Browse Intracranial Hypertension studies →

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital is the lead sponsor of 52 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients over 18 years of age Patients undergoing tympanoplasty surgery under general anesthesia Patients with Patients scheduled for surgery in the lateral head and neck position

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • 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.

    Diagnostic Test: optic nerve diameter

Interventions

  • Diagnostic testoptic nerve diameter

    optic nerve diameter measurement

06

What researchers measure

Primary outcomes

  1. The effect of lateral head position on intracranial pressure

    The effect of lateral head positioning on intracranial pressure will be determined by measuring the diameter of the optic nerve sheath under ultrasound guidance.

    Time frame: 2 years

07

Study locations

1 site
  • Bursa yüksek ihtisas eğitim ve araştırma hastanesi BURSA, Bursa, Türkiye
    Bursa, Bursa 26000, Turkey (Türkiye)
08

References and documents

Publications

  • Altiparmak B, Pinarbasi A, Korkmaz Toker M, Uysal AI, Turan M. Neck extension during thyroidectomy: effects on early postoperative cognitive function and optic nerve sheath diameter- a randomized controlled trial. BMC Anesthesiol. 2025 Dec 1;26(1):15. doi: 10.1186/s12871-025-03507-y. PubMed 41327017 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — The study protocol and results can be shared.

Supporting information: Study protocol

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2020 to primary completion in Jul 2020, 6 months.

Of 37 non-industry interventional studies with no phase under Intracranial Hypertension, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 39. This study's 6 months is below that.

Counting every sponsor, half of 38 studies reached it within 18 months; a quarter within 6 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 29, 2026
First posted
Feb 12, 2026
StartActual
Jan 1, 2020
Primary completionActual
Jul 1, 2020
CompletionActual
Jun 1, 2025
Last update
Feb 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07407972
Lead sponsor
Bursa Yuksek Ihtisas Training and Research Hospital
Responsible party
sermın emınoglu (associate professor, Bursa Yuksek Ihtisas Training and Research Hospital) — Principal investigator
First posted
Feb 12, 2026
Start date
Jan 1, 2020
Primary completion
Jul 1, 2020
Completion
Jun 1, 2025
Last update
Feb 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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