Intracranial Pressure IncreaseNCT05286697
The Effect of Optic Nerve Diameter on Postoperative Cognitive Function in Laparoscopic Hysterectomy
A study testing measuring optic nerve diameter in people with Intracranial Pressure Increase and Postoperative Cognitive Dysfunction, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Intracranial Pressure Increase, Postoperative Cognitive Dysfunction
- What is being tested?
- measuring optic nerve diameter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 19 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 2-3,
- Patients aged 30-75 years who are scheduled for laparoscopic hysterectomy will be included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Optic Nerve Diameter on Postoperative Cognitive Function in Patients in Long Trendelenburg Position in Laparoscopic Hysterectomy Surgery
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.
Read the 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.
- Being tested
- measuring optic nerve diameter
- Keywords
- laparoscopic hysterectomy, trendelenburg position, optic nerve sheath diameter (ONSD), Mini Mental State Examination (MMSE), postoperative cognitive dysfunction
- Medical subject headings
- Intracranial Hypertension, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measuring optic nerve diameterDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| effect of increase intracranial pressure on postoperatve cognitive function | Other | 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. Receives: Diagnostic Test: measuring optic nerve diameter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve diameter measurement
all patients' Optic nerve diameter will be measured by the same experienced anesthetist and recorded
Measured: Intraoperative
Secondary outcomes (1)
mini mental test
mini mental assessment test will be done and recorded for the patients.
Measured: Baseline (before surgery) and immediately after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start15 Mar 2022
- Primary completion28 Mar 2022
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Pressure IncreaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meliha Orhon, Marmara University
- Investigators
- MELIHA ORHON ERGUN, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286697
- Sponsor's protocol ID
- 09.2021.1035
- Status last verified
- Mar 2022
- First submitted
- 22 Feb 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Optic Nerve Diameter on Postoperative Cognitive Function in Patients in Long Trendelenburg Position in Laparoscopic Hysterectomy Surgery
- ClinicalTrials.gov ID
- NCT05286697
- Acronym / sponsor ID
- 09.2021.1035
- Keywords
- laparoscopic hysterectomy, trendelenburg position, optic nerve sheath diameter (ONSD), Mini Mental State Examination (MMSE), postoperative cognitive dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| effect of increase intracranial pressure on postoperatve cognitive function | Other | Diagnostic Test: measuring optic nerve diameterAll 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 2-3,
- Patients aged 30-75 years who are scheduled for laparoscopic hysterectomy will be included.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measuring optic nerve diameterDuring 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. | Diagnostic test | effect of increase intracranial pressure on postoperatve cognitive function |
Primary outcome
Optic nerve diameter measurement
Time frame: Intraoperative
all patients' Optic nerve diameter will be measured by the same experienced anesthetist and recorded
1 secondary outcome
mini mental test
Time frame: Baseline (before surgery) and immediately after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MELIHA ORHON ERGUN principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measuring optic nerve diameter in people with Intracranial Pressure Increase and Postoperative Cognitive Dysfunction, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve diameter measurement (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.