Evaluation of the Effect of Trendelenburg Position Duration on Intracranial Pressure

NCT06048900 | Completed

• 1 other identifier: ESOGU1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The Lloyd Davies position is a position used in laparoscopic hysterectomies where the head is lowered 45 degrees and the legs are bent from the knee area.It is a version of the Trendelenburg position. Both this position and for laparoscopic surgery carbon dioxide (CO2) gas given into the abdomen, causes problems for the patient. Increased abdominal and thoracic pressure impairs venous return and increases intracranial pressure. Optic nerve sheath diameter can be measured by placing an ultrasound probe over the eye. It is possible to follow up the increase in intracranial pressure with this diameter measurement. In this study, it was planned to measure the optic nerve sheath diameter by ultrasound in patients who will undergo laparoscopic hysterectomy. It is aimed to observe the changes in the increase in intracranial pressure as the time lengthens with the measurements to be made at certain intervals during the operation. Secondary aim is to determine whether there is a cut-off value where the intracranial pressure starts to increase.

Conditions

Intracranial Pressure Increase

Keywords

optic nerve sheath diameter measurement; trendelenburg position; laparoscopic hysterectomy

Outcome Measures

Primary Outcomes (1)

• optic nerve sheath diameter measurement

  increase in optic nerve sheath diameter

  during the surgery

Secondary Outcomes (1)

• Timing of increased intracranial pressure

  during the surgery

Study Arms (1)

Optic nerve sheath diameter measurements

OTHER

A total of 7 measurements were planned to be made at specified times.

Device: ultrasound guided optic nerve sheath diameter measurement

Interventions

ultrasound guided optic nerve sheath diameter measurement DEVICE

First, both eyes were measured in a neutral position while awake and after intubation. Measurements were made at regular intervals until the end of the operation after the head-down position and in the neutral position after the operation.

Optic nerve sheath diameter measurements

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Patients who will undergo laparoscopic hysterectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who will undergo laparoscopic hysterectomy

You may not qualify if:

• chronic lung disease, pulmonary hypertension
• glaucoma
• history of eye surgery
• diabetic retinopathy
• intracranial mass,
• hydrocephalus
• history of intracranial surgery
• American society of anesthesiology (ASA) physical classification IV
• optic neuritis
• who do not want to participate in the study.

Sponsors & Collaborators

• Dilek Cetinkaya: lead

Study Sites (1)

Eskisehir Osmangazi University Medical Faculty

Eskişehir, Odunpazarı, 26040, Turkey (Türkiye)

Location

Related Publications (3)

• Chin JH, Seo H, Lee EH, Lee J, Hong JH, Hwang JH, Kim YK. Sonographic optic nerve sheath diameter as a surrogate measure for intracranial pressure in anesthetized patients in the Trendelenburg position. BMC Anesthesiol. 2015 Mar 31;15:43. doi: 10.1186/s12871-015-0025-9. eCollection 2015.

  PMID: 25861241 BACKGROUND

• Ohle R, McIsaac SM, Woo MY, Perry JJ. Sonography of the Optic Nerve Sheath Diameter for Detection of Raised Intracranial Pressure Compared to Computed Tomography: A Systematic Review and Meta-analysis. J Ultrasound Med. 2015 Jul;34(7):1285-94. doi: 10.7863/ultra.34.7.1285.

  PMID: 26112632 BACKGROUND

• Guloglu H, Cetinkaya D, Oge T, Bilir A. Evaluation of the effect of trendelenburg position duration on intracranial pressure in laparoscopic hysterectomies using ultrasonographic optic nerve sheath diameter measurements. BMC Anesthesiol. 2024 Jul 15;24(1):238. doi: 10.1186/s12871-024-02624-4.

  PMID: 39010013 DERIVED

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Dilek Çetinkaya

  Eskisehir Osmangazi University Medical Faculty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: In patients in head-down position who will undergo laparoscopic hysterectomy, it is planned to measure the optic nerve sheath diameter with ultrasound at the beginning and at certain periods of the surgery.

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: March 10, 2021
• Primary Completion: September 15, 2022
• Study Completion: October 15, 2022
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)