Evaluation of the Effect of Trendelenburg Position Duration on Intracranial Pressure

Intracranial Pressure Increase Clinical Trial

Official title:

Evaluation of the Effect of Trendelenburg Position Time on Intracranial Pressure in Laparoscopic With Ultrasonographic Optic Nerve Sheath Diameter Measurement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06048900
• Other study ID #: ESOGU1
• Status: Completed
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: October 15, 2022

Study information

• Verified date: September 2023
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intracranial Hypertension
• Intracranial Pressure Increase

Intervention

Device:
• ultrasound guided optic nerve sheath diameter measurement
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.

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University Medical Faculty	Eskisehir	Odunpazari

Sponsors (1)

Lead Sponsor	Collaborator
Dilek Cetinkaya

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	optic nerve sheath diameter measurement	increase in optic nerve sheath diameter	during the surgery
Secondary	Timing of increased intracranial pressure	If the sheath diameter is over 5 mm, increased pressure will be accepted.	during the surgery