Evaluation of the Effect of Trendelenburg Position Duration on Intracranial Pressure

Sponsor
Dilek Cetinkaya (Other)
Overall Status
Completed
CT.gov ID
NCT06048900
Collaborator
(none)
25
1
1
19.2
1.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: ultrasound guided optic nerve sheath diameter measurement
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Screening
Official Title:
Evaluation of the Effect of Trendelenburg Position Time on Intracranial Pressure in Laparoscopic With Ultrasonographic Optic Nerve Sheath Diameter Measurement
Actual Study Start Date :
Mar 10, 2021
Actual Primary Completion Date :
Sep 15, 2022
Actual Study Completion Date :
Oct 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Optic nerve sheath diameter measurements

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

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.

Outcome Measures

Primary Outcome Measures

  1. optic nerve sheath diameter measurement [during the surgery]

    increase in optic nerve sheath diameter

Secondary Outcome Measures

  1. Timing of increased intracranial pressure [during the surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eskisehir Osmangazi University Medical Faculty Eskisehir Odunpazarı Turkey 26040

Sponsors and Collaborators

  • Dilek Cetinkaya

Investigators

  • Study Chair: Dilek Çetinkaya, Eskisehir Osmangazi University Medical Faculty

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dilek Cetinkaya, Associate Professor, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier:
NCT06048900
Other Study ID Numbers:
  • ESOGU1
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dilek Cetinkaya, Associate Professor, Eskisehir Osmangazi University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2023