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

NCT ID: NCT01669135

Last Updated: 2012-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-08-31

Brief Summary

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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

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Conditions

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Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery

Keywords

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cerebral oximetry cesarean delivery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Spinal Anesthesia with cerebral oxygen saturation monitoring

Intervention Type OTHER

Interventions

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Spinal Anesthesia with cerebral oxygen saturation monitoring

Intervention Type OTHER

Other Intervention Names

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INVOS (cerebral oximeter model 5100, Somanetics, Troy, MI, USA)

Eligibility Criteria

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Inclusion Criteria

* Term healthy parturients

Exclusion Criteria

* Body Mass Index \> 35
* preeclampsia
* neurological,cardiovascular, respiratory disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Argyro Fassoulaki

MD, PhD, DEAA

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesiology, Aretaieio Hospital

Athens, , Greece

Site Status

Countries

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Greece

References

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Fassoulaki A, Paraskeva A, Tsaroucha A. Cesarean delivery under spinal anesthesia is associated with decreases in cerebral oxygen saturation as assessed by NIRS: an observational study. Curr Med Res Opin. 2014 Mar;30(3):331-7. doi: 10.1185/03007995.2013.852526. Epub 2013 Nov 8.

Reference Type DERIVED
PMID: 24106922 (View on PubMed)

Other Identifiers

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M19-12-21-2010

Identifier Type: -

Identifier Source: org_study_id