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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:
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
History of Changes
  Purpose

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 Intervention
Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery
 Other: Spinal Anesthesia with cerebral oxygen saturation monitoring

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Athens:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Enrollment: 34
Study Start Date: December 2010
Study Completion Date: August 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669135

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

No publications provided

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
Study First Received: August 8, 2012
Last Updated: August 17, 2012
Health Authority: Greece: Ethics Committee

Keywords provided by University of Athens:
cerebral oximetry
cesarean delivery

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013