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Evaluation of the Effect of Trendelenburg Position Duration on Intracranial Pressure

Primary Purpose

Intracranial Pressure Increase

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ultrasound guided optic nerve sheath diameter measurement
Sponsored by
Dilek Cetinkaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Intracranial Pressure Increase focused on measuring optic nerve sheath diameter measurement, trendelenburg position, laparoscopic hysterectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Patients who will undergo laparoscopic hysterectomy Exclusion Criteria: 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.

Sites / Locations

  • Eskisehir Osmangazi University Medical Faculty

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Optic nerve sheath diameter measurements

Arm Description

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

Outcomes

Primary Outcome Measures

optic nerve sheath diameter measurement
increase in optic nerve sheath diameter

Secondary Outcome Measures

Timing of increased intracranial pressure
If the sheath diameter is over 5 mm, increased pressure will be accepted.

Full Information

First Posted
September 12, 2023
Last Updated
September 19, 2023
Sponsor
Dilek Cetinkaya
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1. Study Identification

Unique Protocol Identification Number
NCT06048900
Brief Title
Evaluation of the Effect of Trendelenburg Position Duration on Intracranial Pressure
Official Title
Evaluation of the Effect of Trendelenburg Position Time on Intracranial Pressure in Laparoscopic With Ultrasonographic Optic Nerve Sheath Diameter Measurement
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
October 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dilek Cetinkaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The Trendelenburg position is the patient's head down with the table tilted, with the head closer to the floor than the feet. Lloyd Davies position is a modified version of the Trendelenburg position, used especially in laparoscopic hysterectomies, where the head is lowered 30-45° and the legs are bent at knee level. During this surgery, pneumoperitoneum is also applied by administering carbon dioxide (CO2) into the abdomen. During this surgery, pneumoperitoneum is also applied by administering CO2 into the abdomen. The applied position and intra-abdominal CO2 cause some physiological changes. These changes include respiratory and cardiac changes as well as increased intracranial pressure. Optic nerve sheath diameter can be measured by placing an ultrasound probe over the eye. Increase in intracranial pressure can be followed by sequential measurements. 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. Before the patients were given anesthesia induction, optic nerve sheath diameter measurement (ONSD) was performed by imaging in the sagittal and transverse planes in both eyes in neutral position. The second measurement was taken 2 minutes after endotracheal intubation in the neutral position. After the trocars were placed and pneumoperitoneum was applied, the patient was placed in the Lloyd Davies position. After the position was given, bilateral ONSD measurements were taken at the 30th minute, 60th minute, 75th minute, and 90th minute. At the end of the surgery, pneumoperitoneum and position were neutralized. The last measurement was taken 5 minutes after the patient was placed in the neutral position. Near infrared spectrometry (NIRS) monitoring was performed throughout the surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Pressure Increase
Keywords
optic nerve sheath diameter measurement, trendelenburg position, laparoscopic hysterectomy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optic nerve sheath diameter measurements
Arm Type
Other
Arm Description
A total of 7 measurements were planned to be made at specified times.
Intervention Type
Device
Intervention Name(s)
ultrasound guided optic nerve sheath diameter measurement
Intervention Description
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.
Primary Outcome Measure Information:
Title
optic nerve sheath diameter measurement
Description
increase in optic nerve sheath diameter
Time Frame
during the surgery
Secondary Outcome Measure Information:
Title
Timing of increased intracranial pressure
Description
If the sheath diameter is over 5 mm, increased pressure will be accepted.
Time Frame
during the surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patients who will undergo laparoscopic hysterectomy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who will undergo laparoscopic hysterectomy Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Çetinkaya
Organizational Affiliation
Eskisehir Osmangazi University Medical Faculty
Official's Role
Study Chair
Facility Information:
Facility Name
Eskisehir Osmangazi University Medical Faculty
City
Eskisehir
State/Province
Odunpazarı
ZIP/Postal Code
26040
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make individual participant data (IPD) available.
Citations:
PubMed Identifier
25861241
Citation
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.
Results Reference
background
PubMed Identifier
26112632
Citation
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.
Results Reference
background

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Evaluation of the Effect of Trendelenburg Position Duration on Intracranial Pressure

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