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

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ClinicalTrials.gov Identifier: NCT01669135
Recruitment Status : Completed
First Posted : August 20, 2012
Last Update Posted : August 20, 2012
Sponsor:
Information provided by (Responsible Party):
Argyro Fassoulaki, University of Athens

Brief 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.

Condition or disease Intervention/treatment Phase
Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery Other: Spinal Anesthesia with cerebral oxygen saturation monitoring Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : December 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Other: Spinal Anesthesia with cerebral oxygen saturation monitoring
Other Name: INVOS (cerebral oximeter model 5100, Somanetics, Troy, MI, USA)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Term healthy parturients

Exclusion Criteria:

  • Body Mass Index > 35
  • preeclampsia
  • neurological,cardiovascular, respiratory disease

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669135


Locations
Greece
Department of Anesthesiology, Aretaieio Hospital
Athens, Greece, 11528
Sponsors and Collaborators
University of Athens

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Argyro Fassoulaki, MD, PhD, DEAA, University of Athens
ClinicalTrials.gov Identifier: NCT01669135     History of Changes
Other Study ID Numbers: M19-12-21-2010
First Posted: August 20, 2012    Key Record Dates
Last Update Posted: August 20, 2012
Last Verified: August 2012

Keywords provided by Argyro Fassoulaki, University of Athens:
cerebral oximetry
cesarean delivery

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs