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

August 17, 2012 updated by: Argyro Fassoulaki, University of Athens
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11528
        • Department of Anesthesiology, Aretaieio Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Term healthy parturients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from the performing of spinal anesthesia untill 1 minute after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5, 10, 50 min after spinal,1 minute after delivery
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
5, 10, 50 min after spinal, 1 minute after delivery
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
5, 10, 50 min after spinal, 1 minute after delivery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5, 10, 50 min after spinal, 1 minute after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

August 8, 2012

First Submitted That Met QC Criteria

August 17, 2012

First Posted (Estimate)

August 20, 2012

Study Record Updates

Last Update Posted (Estimate)

August 20, 2012

Last Update Submitted That Met QC Criteria

August 17, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M19-12-21-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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