NCT05195801

Brief Summary

This study aimed to measure optic nerve sheath changes in the intraoperative period in patients who underwent vitrectomy surgery and to investigate the intraoperative factors that may affect this. Standard anesthesia protocol will be applied to all patients participating in the study. Optic nerve sheath diameter measurements of the patients taken to the operating room will be made on the operating table by ultrasonography method. Standard anesthesia induction will be performed following SpO2 and ECG monitoring in routine anesthesia monitoring. Depth of anesthesia will be evaluated with routine hemodynamic data.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

2.5 years

First QC Date

January 7, 2022

Last Update Submit

January 12, 2023

Conditions

Keywords

vitrectomygeneral anaesthesiaoptic nerveintraocular pressurevision field

Outcome Measures

Primary Outcomes (1)

  • Optic Nerve Diameter

    This study aims to use the anesthesia methods routinely applied in our hospital's vitrectomy operations. With general anesthesia, intracranial pressure changes, an indication of which is an increase in the diameter of the optic nerve sheath. The expected benefit of this study is to reveal the effects of general anesthesia, patient profile (age, comorbidity, BMI), ventilator parameters on optic nerve sheath diameter in patients undergoing vitrectomy surgery, and to provide optimal intraoperative conditions in the surgery of these patients with parameters that can be corrected and to improve their vision in the postoperative period. The optic nerve diameter will be measured at determined time intervals, and changes in diameter will be noted in the study.

    one month

Secondary Outcomes (1)

  • Vision field

    one month

Study Arms (3)

Group with local anesthesia

The group that did not apply general anesthesia

Device: USG

Group with Sevoflurane

The Sevoflurane used for maintenance of general anesthesia

Device: USG

Group with Propofol

The Propofol (IV) used for maintenance of general anesthesia

Device: USG

Interventions

USGDEVICE

Optic Nerve Diameter will be measured in the intraoperative period and postoperative 1st month by ultrasonography method.

Group with PropofolGroup with SevofluraneGroup with local anesthesia

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing vitrectomy surgery

You may qualify if:

  • Being over 18 years old
  • Taken to elective vitrectomy surgery
  • Asa I - II - III patients
  • GKS 15

You may not qualify if:

  • Emergency surgeries
  • Patients with a GCS of less than 15 or whose cognitive functions have not been evaluated as clinically sufficient.
  • In cases that cause the termination of the surgical procedure for any reason during the operation
  • Patients followed by neurosurgery and patients with intracranial events

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Akdeniz University Medical Faculty Department of Anesthesiology and Reanimation

Antalya, 07059, Turkey (Türkiye)

RECRUITING

Akdeniz University Hospital

Antalya, 07070, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • Chen LM, Wang LJ, Hu Y, Jiang XH, Wang YZ, Xing YQ. Ultrasonic measurement of optic nerve sheath diameter: a non-invasive surrogate approach for dynamic, real-time evaluation of intracranial pressure. Br J Ophthalmol. 2019 Apr;103(4):437-441. doi: 10.1136/bjophthalmol-2018-312934. Epub 2018 Oct 25.

    PMID: 30361274BACKGROUND
  • Robba C, Santori G, Czosnyka M, Corradi F, Bragazzi N, Padayachy L, Taccone FS, Citerio G. Optic nerve sheath diameter measured sonographically as non-invasive estimator of intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2018 Aug;44(8):1284-1294. doi: 10.1007/s00134-018-5305-7. Epub 2018 Jul 17.

    PMID: 30019201BACKGROUND
  • Blair K, Czyz CN. Retinal Detachment. 2024 Feb 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK551502/

    PMID: 31855346BACKGROUND
  • Illarionov AM. [The blood coagulation and its fibrinolytic activity in patients who have sustained an apoplectic stroke]. Sov Med. 1966 Feb;29(2):76-7. No abstract available. Russian.

    PMID: 6011519BACKGROUND

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ilker O Aycan, Prof

CONTACT

Bora Di̇nc, Assist Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

January 7, 2022

First Posted

January 19, 2022

Study Start

January 1, 2022

Primary Completion

July 1, 2024

Study Completion

September 1, 2024

Last Updated

January 13, 2023

Record last verified: 2023-01

Locations