NCT07407972

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

January 29, 2026

Last Update Submit

February 10, 2026

Conditions

Keywords

tympanoplastylateral positionoptic nerve diameterintracranial pressureheadache and sore throat

Outcome Measures

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.

    2 years

Study Arms (1)

ONSD Measurement

OTHER

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

optic nerve diameterDIAGNOSTIC_TEST

optic nerve diameter measurement

ONSD Measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bursa, Bursa, 26000, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Intracranial HypertensionHeadachePharyngitis

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 12, 2026

Study Start

January 1, 2020

Primary Completion

July 1, 2020

Study Completion

June 1, 2025

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

The study protocol and results can be shared.

Shared Documents
STUDY PROTOCOL

Locations