Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean DeliveryNCT01669135
Spinal Anesthesia for Cesarean Delivery is Associated With Decreases in Regional Cerebral Oxygen Saturation as Assessed by Near- Infrared Spectroscopy
A study testing Spinal Anesthesia with cerebral oxygen saturation monitoring in people with Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery, run by University of Athens at 1 site in Greece.
Trial summary
The cerebral oxygen saturation is assessed by means of near-infrared spectometry in parturients undergoing cesarean delivery under spinal anesthesia. The investigators hypothesis was that spinal anesthesia does not influence cerebral oxygen saturation. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery
- What is being tested?
- Spinal Anesthesia with cerebral oxygen saturation monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2010to Aug 2012
- 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 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Term healthy parturients
Who cannot join
- Body Mass Index > 35
- preeclampsia
- neurological,cardiovascular, respiratory disease
Trial locations and contacts
1 site in 1 country.
About this study
The cerebral oxygen saturation is assessed by means of near-infrared spectometry in parturients undergoing cesarean delivery under spinal anesthesia. The investigators hypothesis was that spinal anesthesia does not influence cerebral oxygen saturation.
- Being tested
- Spinal Anesthesia with cerebral oxygen saturation monitoring
- Keywords
- cerebral oximetry, cesarean delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Anesthesia with cerebral oxygen saturation monitoringOther
Also called INVOS (cerebral oximeter model 5100, Somanetics, Troy, MI, USA)
| Study group | Role | What they receive |
|---|---|---|
| Spinal Anesthesia with cerebral oxygen saturation monitoring | Other | The cerebral oxygen saturation of the right and left frontal lobe as well as the thigh oxygen saturation are monitored during spinal anesthesia by means of the near-infrared spectroscopy. Hemodynamic variables were recorded at the same time points. Receives: Other: Spinal Anesthesia with cerebral oxygen saturation monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral oxygen saturation of the right frontal lobe
Cerebral oxygen saturation is important as it may affect patient's outcome
Measured: Change from the performing of spinal anesthesia untill 1 minute after delivery
Secondary outcomes (3)
cerebral oxygen saturation of the left frontal lobe
Cerebral oxygen saturation is important for patient's outcome
Measured: 5, 10, 50 min after spinal,1 minute after delivery
Thigh oxygen saturation
Thigh oxygen saturation may reflect blood redistribution due to spinal block
Measured: 5, 10, 50 min after spinal, 1 minute after delivery
Arterial Oxygenation
Changes in arterial oxygenation may reflect blood redistribution due to spinal block
Measured: 5, 10, 50 min after spinal, 1 minute after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startDec 2010
- Primary completionMay 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean DeliveryStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Argyro Fassoulaki, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669135
- Sponsor's protocol ID
- M19-12-21-2010
- Status last verified
- Aug 2012
- First submitted
- 8 Aug 2012
- Last updated
- 20 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Fassoulaki A, Paraskeva A, Tsaroucha A. Cesarean delivery under spinal anesthesia is associated with decreases in cerebral oxygen saturation as assessed by NIRS: an observational study. Curr Med Res Opin. 2014 Mar;30(3):331-7. doi: 10.1185/03007995.2013.852526. Epub 2013 Nov 8.
PubMed 24106922
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Anesthesia for Cesarean Delivery is Associated With Decreases in Regional Cerebral Oxygen Saturation as Assessed by Near- Infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT01669135
- Acronym / sponsor ID
- M19-12-21-2010
- Keywords
- cerebral oximetry, cesarean delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Aug 2012 (estimated)
- 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.
The cerebral oxygen saturation is assessed by means of near-infrared spectometry in parturients undergoing cesarean delivery under spinal anesthesia. The investigators hypothesis was that spinal anesthesia does not influence cerebral oxygen saturation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Anesthesia with cerebral oxygen saturation monitoring | Other | Other: Spinal Anesthesia with cerebral oxygen saturation monitoringThe cerebral oxygen saturation of the right and left frontal lobe as well as the thigh oxygen saturation are monitored during spinal anesthesia by means of the near-infrared spectroscopy. Hemodynamic variables were recorded at the same time points. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Term healthy parturients
Key exclusion criteria (3 listed)
- Body Mass Index > 35
- preeclampsia
- neurological,cardiovascular, respiratory disease
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 |
|---|---|---|
| Spinal Anesthesia with cerebral oxygen saturation monitoringAlso: INVOS (cerebral oximeter model 5100, Somanetics, Troy, MI, USA) | Other | Spinal Anesthesia with cerebral oxygen saturation monitoring |
Primary outcome
cerebral oxygen saturation of the right frontal lobe
Time frame: Change from the performing of spinal anesthesia untill 1 minute after delivery
Cerebral oxygen saturation is important as it may affect patient's outcome
3 secondary outcomes
cerebral oxygen saturation of the left frontal lobe
Time frame: 5, 10, 50 min after spinal,1 minute after delivery
Thigh oxygen saturation
Time frame: 5, 10, 50 min after spinal, 1 minute after delivery
Arterial Oxygenation
Time frame: 5, 10, 50 min after spinal, 1 minute after delivery
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 20 Aug 2012.
- Derived from this study: PubMed 24106922Fassoulaki A, Paraskeva A, Tsaroucha A. Cesarean delivery under spinal anesthesia is associated with decreases in cerebral oxygen saturation as assessed by NIRS: an observational study. Curr Med Res Opin. 2014 Mar;30(3):331-7. doi: 10.1185/03007995.2013.852526. Epub 2013 Nov 8.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Anesthesia with cerebral oxygen saturation monitoring in people with Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery, run by University of Athens at 1 site in Greece.
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 1 inclusion and 3 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 20 Aug 2012. 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 Greece. 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?
cerebral oxygen saturation of the right frontal lobe (time frame: Change from the performing of spinal anesthesia untill 1 minute after delivery). 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 NCT01669135, which also lists 1 linked publication.
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 20 Aug 2012.