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

Tracking Information
First Received Date ^ICMJE	August 8, 2012
Last Updated Date	August 17, 2012
Start Date ^ICMJE	December 2010
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 17, 2012)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01669135 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 17, 2012)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE (submitted: August 17, 2012)	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
Original Other Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Spinal Anesthesia for Cesarean Delivery is Associated With Decreases in Regional Cerebral Oxygen Saturation as Assessed by Near- Infrared Spectroscopy
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery
Intervention ^ICMJE	Other: Spinal Anesthesia with cerebral oxygen saturation monitoring Other Name: INVOS (cerebral oximeter model 5100, Somanetics, Troy, MI, USA)
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	34
Completion Date	August 2012
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Term healthy parturients Exclusion Criteria: Body Mass Index > 35 preeclampsia neurological,cardiovascular, respiratory disease
Gender	Female
Ages	18 Years to 48 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Greece

Administrative Information
NCT Number ^ICMJE	NCT01669135
Other Study ID Numbers ^ICMJE	M19-12-21-2010
Has Data Monitoring Committee	No
Responsible Party	Argyro Fassoulaki, University of Athens
Study Sponsor ^ICMJE	University of Athens
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Athens
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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