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

Sponsor
University of Athens (Other)
Overall Status
Completed
CT.gov ID
NCT01669135
Collaborator
(none)
34
Enrollment
1
Location
1
Arm
20
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Spinal Anesthesia with cerebral oxygen saturation monitoring
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Study Start Date :
Dec 1, 2010
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
Aug 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Other: 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 Names:
  • INVOS (cerebral oximeter model 5100, Somanetics, Troy, MI, USA)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. cerebral oxygen saturation of the right frontal lobe [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 [5, 10, 50 min after spinal,1 minute after delivery]

      Cerebral oxygen saturation is important for patient's outcome

    2. Thigh oxygen saturation [5, 10, 50 min after spinal, 1 minute after delivery]

      Thigh oxygen saturation may reflect blood redistribution due to spinal block

    3. Arterial Oxygenation [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) [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 48 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Term healthy parturients
    Exclusion Criteria:

    • Body Mass Index > 35

    • preeclampsia

    • neurological,cardiovascular, respiratory disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology, Aretaieio Hospital Athens Greece 11528

    Sponsors and Collaborators

    • University of Athens

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Argyro Fassoulaki, MD, PhD, DEAA, University of Athens
    ClinicalTrials.gov Identifier:
    NCT01669135
    Other Study ID Numbers:
    • M19-12-21-2010
    First Posted:
    Aug 20, 2012
    Last Update Posted:
    Aug 20, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Argyro Fassoulaki, MD, PhD, DEAA, University of Athens
    cerebral oximetry
    cesarean delivery
    Additional relevant MeSH terms:
    Anesthetics

    Study Results

    No Results Posted as of Aug 20, 2012