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Spinal Anesthesia for Cesarean Delivery is Associated With Decreases in Regional Cerebral Oxygen Saturation as Assessed by Near- Infrared Spectroscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01669135
First Posted: August 20, 2012
Last Update Posted: August 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Argyro Fassoulaki, University of Athens
August 8, 2012
August 20, 2012
August 20, 2012
December 2010
May 2012   (Final data collection date for 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 ]
Cerebral oxygen saturation is important as it may affect patient's outcome
Same as current
No Changes Posted
  • cerebral oxygen saturation of the left frontal lobe [ Time Frame: 5, 10, 50 min after spinal,1 minute after delivery ]
    Cerebral oxygen saturation is important for patient's outcome
  • Thigh oxygen saturation [ Time Frame: 5, 10, 50 min after spinal, 1 minute after delivery ]
    Thigh oxygen saturation may reflect blood redistribution due to spinal block
  • Arterial Oxygenation [ Time Frame: 5, 10, 50 min after spinal, 1 minute after delivery ]
    Changes in arterial oxygenation may reflect blood redistribution due to spinal block
Same as current
Hemodynamic changes (Changes in Blood Pressure (mmHg) and Heart rate (beats/min) [ Time Frame: 5, 10, 50 min after spinal, 1 minute after delivery ]
Hemodynamic changes (changes in Blood Pressure and Heart rate) may reflect blood redistribution due to spinal block
Same as current
 
Spinal Anesthesia for Cesarean Delivery is Associated With Decreases in Regional Cerebral Oxygen Saturation as Assessed by Near- Infrared Spectroscopy
Not Provided
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery
Other: Spinal Anesthesia with cerebral oxygen saturation monitoring
Other Name: INVOS (cerebral oximeter model 5100, Somanetics, Troy, MI, USA)
Spinal Anesthesia with cerebral oxygen saturation monitoring
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.
Intervention: Other: Spinal Anesthesia with cerebral oxygen saturation monitoring
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
August 2012
May 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Term healthy parturients

Exclusion Criteria:

  • Body Mass Index > 35
  • preeclampsia
  • neurological,cardiovascular, respiratory disease
Sexes Eligible for Study: Female
18 Years to 48 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
 
NCT01669135
M19-12-21-2010
No
Not Provided
Not Provided
Argyro Fassoulaki, University of Athens
University of Athens
Not Provided
Not Provided
University of Athens
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP