Intracranial Pressure IncreaseNCT04446013
Comparison of ONSD and rSO2 Measurements Between General and Spinal Anesthesia in C-Section
A study testing Optic Nerve Sheath Diameter Measurement in people with Intracranial Pressure Increase, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
General anesthesia and regional anesthesia can be chosen in cesarean operations. Endotracheal intubation and mechanical ventilation are components of general anesthesia. Endotracheal intubation has been shown to cause increased intracranial pressure. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intracranial Pressure Increase
- What is being tested?
- Optic Nerve Sheath Diameter Measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2020to 30 Jul 2020
- 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Undergoing elective c-section operation
- Age between 18-49
- ASA I-II
- Gestational week ≥ 36
Who cannot join
- Ophthalmologic disease and optic nerve pathology
- Increased intracranial pressure
- History of cerebrovascular disease
- Cases where spinal anesthesia is contraindicated
- Emergency cesarean category level 1
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Training and Research Hospital
Istanbul, 34200
About this study
Official title: Comparison of Optic Nerve Sheath Diameter and Cerebral Regional Oxygen Saturation Measurements Between General and Spinal Anesthesia Applications in C-Section
General anesthesia and regional anesthesia can be chosen in cesarean operations. Endotracheal intubation and mechanical ventilation are components of general anesthesia. Endotracheal intubation has been shown to cause increased intracranial pressure. There is not enough information about the effect of spinal anesthesia on intracranial pressure during cesarean operations. Increased intracranial pressure can cause neurological complications by disrupting brain perfusion. For this reason, the investigators think that the safe anesthesia method should be determined especially in pregnant patients who are at risk of increased intracranial pressure.
- Conditions
- Intracranial Pressure Increase
- Being tested
- Optic Nerve Sheath Diameter Measurement
- Keywords
- optic nerve sheath diameter, intracranial pressure, intraabdominal pressure, cerebral regional oxygen saturation, c-section
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic Nerve Sheath Diameter MeasurementOther
The change in intracranial pressure via optic nerve sheath diameter measurement
| Study group | Role | What they receive |
|---|---|---|
| Group General Anesthesia | Experimental | C-Section under general anesthesia Receives: Other: Optic Nerve Sheath Diameter Measurement |
| Grup Spinal Anesthesia | Experimental | C-Section under spinal anesthesia Receives: Other: Optic Nerve Sheath Diameter Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Optic Nerve Sheath Diameter
The change in intracranial pressure via optic nerve sheath diameter measurement during c-section among 5 time point.
Measured: Throughout the surgery
Change in regional cerebral oxygen saturation
The change in regional cerebral oxygen saturation during c-section among 5 time point.
Measured: Throughout the surgery
Secondary outcomes (2)
Perioperative Hemodynamic Parameters
Mean arterial pressure in mmHg
Measured: Throughout the surgery
Perioperative Hemodynamic Parameters
Heart rate beat per minute
Measured: Throughout the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start15 May 2020
- Primary completion25 Jun 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mehmet Can Tunalı, Principal investigator, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446013
- Sponsor's protocol ID
- 2020.05.1.16.048
- Status last verified
- Sep 2020
- First submitted
- 22 Jun 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Geeraerts T, Merceron S, Benhamou D, Vigue B, Duranteau J. Non-invasive assessment of intracranial pressure using ocular sonography in neurocritical care patients. Intensive Care Med. 2008 Nov;34(11):2062-7. doi: 10.1007/s00134-008-1149-x. Epub 2008 May 29.
PubMed 18509619Bauerle J, Nedelmann M. Sonographic assessment of the optic nerve sheath in idiopathic intracranial hypertension. J Neurol. 2011 Nov;258(11):2014-9. doi: 10.1007/s00415-011-6059-0. Epub 2011 Apr 28.
PubMed 21523461Yoshitani K, Kawaguchi M, Miura N, Okuno T, Kanoda T, Ohnishi Y, Kuro M. Effects of hemoglobin concentration, skull thickness, and the area of the cerebrospinal fluid layer on near-infrared spectroscopy measurements. Anesthesiology. 2007 Mar;106(3):458-62. doi: 10.1097/00000542-200703000-00009.
PubMed 17325503
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Optic Nerve Sheath Diameter and Cerebral Regional Oxygen Saturation Measurements Between General and Spinal Anesthesia Applications in C-Section
- ClinicalTrials.gov ID
- NCT04446013
- Acronym / sponsor ID
- 2020.05.1.16.048
- Conditions
- Intracranial Pressure Increase
- Keywords
- optic nerve sheath diameter, intracranial pressure, intraabdominal pressure, cerebral regional oxygen saturation, c-section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 15 May 2020 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 24 Jun 2020 (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.
General anesthesia and regional anesthesia can be chosen in cesarean operations. Endotracheal intubation and mechanical ventilation are components of general anesthesia. Endotracheal intubation has been shown to cause increased intracranial pressure. There is not enough information about the effect of spinal anesthesia on intracranial pressure during cesarean operations. Increased intracranial pressure can cause neurological complications by disrupting brain perfusion. For this reason, the investigators think that the safe anesthesia method should be determined especially in pregnant patients who are at risk of increased intracranial pressure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group General Anesthesia | Experimental | Other: Optic Nerve Sheath Diameter MeasurementC-Section under general anesthesia |
| Grup Spinal Anesthesia | Experimental | Other: Optic Nerve Sheath Diameter MeasurementC-Section under spinal anesthesia |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Undergoing elective c-section operation
- Age between 18-49
- ASA I-II
- Gestational week ≥ 36
Key exclusion criteria (5 listed)
- Ophthalmologic disease and optic nerve pathology
- Increased intracranial pressure
- History of cerebrovascular disease
- Cases where spinal anesthesia is contraindicated
- Emergency cesarean category level 1
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 |
|---|---|---|
| Optic Nerve Sheath Diameter MeasurementThe change in intracranial pressure via optic nerve sheath diameter measurement | Other | Group General Anesthesia, Grup Spinal Anesthesia |
Primary outcome
Change in Optic Nerve Sheath Diameter
Time frame: Throughout the surgery
The change in intracranial pressure via optic nerve sheath diameter measurement during c-section among 5 time point.
Change in regional cerebral oxygen saturation
Time frame: Throughout the surgery
The change in regional cerebral oxygen saturation during c-section among 5 time point.
2 secondary outcomes
Perioperative Hemodynamic Parameters
Time frame: Throughout the surgery
Perioperative Hemodynamic Parameters
Time frame: Throughout the 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 9 Sep 2020.
- Background: PubMed 18509619Geeraerts T, Merceron S, Benhamou D, Vigue B, Duranteau J. Non-invasive assessment of intracranial pressure using ocular sonography in neurocritical care patients. Intensive Care Med. 2008 Nov;34(11):2062-7. doi: 10.1007/s00134-008-1149-x. Epub 2008 May 29.
- Background: PubMed 21523461Bauerle J, Nedelmann M. Sonographic assessment of the optic nerve sheath in idiopathic intracranial hypertension. J Neurol. 2011 Nov;258(11):2014-9. doi: 10.1007/s00415-011-6059-0. Epub 2011 Apr 28.
- Background: PubMed 17325503Yoshitani K, Kawaguchi M, Miura N, Okuno T, Kanoda T, Ohnishi Y, Kuro M. Effects of hemoglobin concentration, skull thickness, and the area of the cerebrospinal fluid layer on near-infrared spectroscopy measurements. Anesthesiology. 2007 Mar;106(3):458-62. doi: 10.1097/00000542-200703000-00009.
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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.
Mehmet Can Tunalı principal investigator
Bagcilar Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optic Nerve Sheath Diameter Measurement in people with Intracranial Pressure Increase, run by Bagcilar Training and Research Hospital 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 4 inclusion and 5 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 9 Sep 2020. 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?
Change in Optic Nerve Sheath Diameter (time frame: Throughout the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04446013, which also lists 3 linked publications.
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 9 Sep 2020.