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:
Information provided by (Responsible Party):
Argyro Fassoulaki, University of Athens
ClinicalTrials.gov Identifier:
NCT01669135
First received: August 8, 2012
Last updated: August 17, 2012
Last verified: August 2012

August 8, 2012
August 17, 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 ] [ Designated as safety issue: Yes ]
Cerebral oxygen saturation is important as it may affect patient's outcome
Same as current
Complete list of historical versions of study NCT01669135 on ClinicalTrials.gov Archive Site
  • cerebral oxygen saturation of the left frontal lobe [ Time Frame: 5, 10, 50 min after spinal,1 minute after delivery ] [ Designated as safety issue: Yes ]
    Cerebral oxygen saturation is important for patient's outcome
  • Thigh oxygen saturation [ Time Frame: 5, 10, 50 min after spinal, 1 minute after delivery ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   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
Female
18 Years to 48 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01669135
M19-12-21-2010
No
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