Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery Clinical Trial
Verified date | August 2012 |
Source | University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | August 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 48 Years |
Eligibility |
Inclusion Criteria: - Term healthy parturients Exclusion Criteria: - Body Mass Index > 35 - preeclampsia - neurological,cardiovascular, respiratory disease |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Greece | Department of Anesthesiology, Aretaieio Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
University of Athens |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hemodynamic changes (Changes in Blood Pressure (mmHg) and Heart rate (beats/min) | Hemodynamic changes (changes in Blood Pressure and Heart rate) may reflect blood redistribution due to spinal block | 5, 10, 50 min after spinal, 1 minute after delivery | Yes |
Primary | cerebral oxygen saturation of the right frontal lobe | Cerebral oxygen saturation is important as it may affect patient's outcome | Change from the performing of spinal anesthesia untill 1 minute after delivery | Yes |
Secondary | cerebral oxygen saturation of the left frontal lobe | Cerebral oxygen saturation is important for patient's outcome | 5, 10, 50 min after spinal,1 minute after delivery | Yes |
Secondary | Thigh oxygen saturation | Thigh oxygen saturation may reflect blood redistribution due to spinal block | 5, 10, 50 min after spinal, 1 minute after delivery | Yes |
Secondary | Arterial Oxygenation | Changes in arterial oxygenation may reflect blood redistribution due to spinal block | 5, 10, 50 min after spinal, 1 minute after delivery | Yes |