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The Effect of Optic Nerve Diameter on Postoperative Cognitive Function in Laparoscopic Hysterectomy

Primary Purpose

Intracranial Pressure Increase, Postoperative Cognitive Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
measuring optic nerve diameter
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intracranial Pressure Increase focused on measuring laparoscopic hysterectomy, trendelenburg position, optic nerve sheath diameter (ONSD), Mini Mental State Examination (MMSE), postoperative cognitive dysfunction

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA 2-3,
  • Patients aged 30-75 years who are scheduled for laparoscopic hysterectomy will be included.

Exclusion Criteria:

  • Patients with a previous history of ocular disease,
  • undergoing ocular surgery,
  • patients with neurological disease and transient ischemic attack,
  • Cases who converted to open surgery will be excluded from the study.

Sites / Locations

  • Marmara University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

effect of increase intracranial pressure on postoperatve cognitive function

Arm Description

All patient will be given a mini mental test before and after the surgery and the optic nerve diameter will be measured 5 times during the surgery.

Outcomes

Primary Outcome Measures

Optic nerve diameter measurement
all patients' Optic nerve diameter will be measured by the same experienced anesthetist and recorded

Secondary Outcome Measures

mini mental test
mini mental assessment test will be done and recorded for the patients.

Full Information

First Posted
February 22, 2022
Last Updated
April 19, 2022
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT05286697
Brief Title
The Effect of Optic Nerve Diameter on Postoperative Cognitive Function in Laparoscopic Hysterectomy
Official Title
The Effect of Optic Nerve Diameter on Postoperative Cognitive Function in Patients in Long Trendelenburg Position in Laparoscopic Hysterectomy Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
March 28, 2022 (Actual)
Study Completion Date
April 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University

4. Oversight

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

5. Study Description

Brief Summary
Prospective study, 40 patients ASA 2-3, 30-75 years old who were planned for laparoscopic hysterectomy operation will be included.One day before the operation and postoperative 1.3.7. A mini mental assessment test will be performed on these days.Standard monitoring and Near-Infrared Spectroscopy monitoring to measure cerebral oxygen saturation will be performed on the patients.NIRS sensors will be placed on the right and left sides of the forehead, 2 cm above the eyebrow, before induction of anesthesia. Before the induction of anesthesia, the measurement will begin and the FiO2 (fraction of inspiration oxygen) will be kept at 60%.General anesthesia induction will be made with propofol 2mg/kg, remifentanil 0.5 µg/kg and rocuronium 0.6mg/kg, and maintenance will be provided with 2% sevoflurane.The patient will be intubated and ventilation support will be provided so that the tidal volume is 6-8 ml/kg and the end tidal CO2 is 30-40 mmHg. PEEP (Positive end expiratory pressure) will not be applied to any patient. Intra-abdominal pressure will be maintained at 15 mmHg. All patients will be given 1gr paracetamol and 100mg tramadol for postoperative analgesia.During the measurement of optic nerve diameter, a layer of sterile water-soluble gel will be applied on the closed eyelid with a linear 10-5 MHz ultrasound probe. In our study, ONSDs of all patients will be measured by the same experienced anesthetist. Measurements will be made at 5 different times. 5 minutes after induction of anesthesia in the supine position (T0), 5 minutes after the onset of pneumoperitoneum (T1), 5 minutes after the upright trendelenburg position (T2), at the 2nd hour of the trendelenburg position (T3) and 5 minutes after returning to the supine position at the end of the surgery (T4) .ONSD measurements of the patients measured at 5 different times, peroperative NIRS values, peroperative SpO2, mean blood pressure, peak heart rate, anesthesia time, surgery time, time to stay in the trendelenburg position, partial oxygen saturation (PaO2), PCO2, end-tidal carbon dioxide (ETCO2) and peak airway pressure (pPEAK) will be recorded.
Detailed Description
To show whether the relationship between increased intracranial pressure and optic nerve diameter after long (> 2.5 hours) Trendelenburg laparoscopic hysterectomies has an effect on postoperative cognitive functions. Laparoscopic surgery has been developing rapidly in recent years. The fact that the bleeding risk and hospital stay are less, less pain, faster return to normal work, better cosmetic results and superior patient morbidity have made laparoscopic interventions more preferable (1). CO2 pneumoperitoneum and upright upside-down position (Trendelenburg position) are applied to patients who will undergo laparoscopic surgery for better visualization of the surgical field. However, the combined use of the pneumoperitoneum and trendelenburg position causes an increase in intraabdominal pressure, which triggers many systemic physiological changes, along with a decrease in venous return, and increases cerebral blood flow, intracranial pressure, and intraocular pressure (2,3). Optic nerve sheath diameter (ONSD), determined by non-invasive ocular sonography, is a simple and reliable method that is an indicator of increased intracranial pressure (ICP) in patients (4). Studies have found 100% sensitivity and specificity in the prediction that if ONSD is >5.5, ICP will be >20 mmHg (5,6). The effect of ONSD on postoperative delirium or postoperative cognitive dysfunction has not been fully explained in the literature. The aim of our study; To show whether the relationship between increased intracranial pressure and ONSD after long-lasting (>2.5 hours) Trendelenburg laparoscopic hysterectomies has an effect on postoperative cognitive functions. In this prospective and observational study, 40 patients ASA 2-3, 30-75 years old who were planned for laparoscopic hysterectomy operation will be included. Patients with a previous history of ocular disease, ocular surgery, neurological disease and transient ischemic attack will be excluded from the study. Cases returning to open surgery will be excluded from the study. One day before the operation and postoperative 1.3.7. A mini mental assessment test (MMSE-Mini Mental State Examination) will be performed on these days. Standard monitoring (electrocardiography-ECG, pulse oximetry, noninvasive arterial blood pressure) and Near-Infrared Spectroscopy (NIRS) monitoring to measure cerebral oxygen saturation will be performed on the patients. NIRS sensors will be placed on the right and left sides of the forehead, 2 cm above the eyebrow, before induction of anesthesia. Before the induction of anesthesia, the measurement will begin and the FiO2 (fraction of inspiration oxygen) will be kept at 60%. If cerebral oxygen decreases by more than 20% or is below 50% absolute, position will be changed or FiO2 will be increased. General anesthesia induction will be made with propofol 2mg/kg, remifentanil 0.5 µg/kg and rocuronium 0.6mg/kg, and maintenance will be provided with 2% sevoflurane. The patient will be intubated and ventilation support will be provided so that the tidal volume is 6-8 ml/kg and the end tidal CO2 is 30-40 mmHg. PEEP (Positive end expiratory pressure) will not be applied to any patient. Intra-abdominal pressure will be maintained at 15 mmHg. All patients will be given 1gr paracetamol and 100mg tramadol for postoperative analgesia. During the measurement of optic nerve diameter, a layer of sterile water-soluble gel will be applied on the closed eyelid with a linear 10-5 MHz ultrasound probe. In our study, ONSDs of all patients will be measured by the same experienced anesthetist. SPSS 21.0 computer program will be used for statistical analysis. Based on our pilot study data, a minimum sample size of 23 patients with 0.05 alpha and 90% power indicated that a sample size would be required.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Pressure Increase, Postoperative Cognitive Dysfunction
Keywords
laparoscopic hysterectomy, trendelenburg position, optic nerve sheath diameter (ONSD), Mini Mental State Examination (MMSE), postoperative cognitive dysfunction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
effect of increase intracranial pressure on postoperatve cognitive function
Arm Type
Other
Arm Description
All patient will be given a mini mental test before and after the surgery and the optic nerve diameter will be measured 5 times during the surgery.
Intervention Type
Diagnostic Test
Intervention Name(s)
measuring optic nerve diameter
Intervention Description
During the measurement of the optic nerve diameter, a layer of sterile water-soluble gel will be applied on the closed eyelid with a linear 10-5 MHz ultrasound probe.
Primary Outcome Measure Information:
Title
Optic nerve diameter measurement
Description
all patients' Optic nerve diameter will be measured by the same experienced anesthetist and recorded
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
mini mental test
Description
mini mental assessment test will be done and recorded for the patients.
Time Frame
Baseline (before surgery) and immediately after surgery.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA 2-3, Patients aged 30-75 years who are scheduled for laparoscopic hysterectomy will be included. Exclusion Criteria: Patients with a previous history of ocular disease, undergoing ocular surgery, patients with neurological disease and transient ischemic attack, Cases who converted to open surgery will be excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MELIHA ORHON ERGUN
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University
City
Istanbul
State/Province
Maltepe
ZIP/Postal Code
34854
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Optic Nerve Diameter on Postoperative Cognitive Function in Laparoscopic Hysterectomy

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