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

Sponsors

Lead sponsor: University of Athens

Source University of Athens
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.

Overall Status Completed
Start Date December 2010
Completion Date August 2012
Primary Completion Date May 2012
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
cerebral oxygen saturation of the right frontal lobe Change from the performing of spinal anesthesia untill 1 minute after delivery
Secondary Outcome
Measure Time Frame
cerebral oxygen saturation of the left frontal lobe 5, 10, 50 min after spinal,1 minute after delivery
Thigh oxygen saturation 5, 10, 50 min after spinal, 1 minute after delivery
Arterial Oxygenation 5, 10, 50 min after spinal, 1 minute after delivery
Enrollment 34
Condition
Intervention

Intervention type: Other

Intervention name: Spinal Anesthesia with cerebral oxygen saturation monitoring

Arm group label: Spinal Anesthesia with cerebral oxygen saturation monitoring

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

Eligibility

Criteria:

Inclusion Criteria:

- Term healthy parturients

Exclusion Criteria:

- Body Mass Index > 35

- preeclampsia

- neurological,cardiovascular, respiratory disease

Gender: Female

Minimum age: 18 Years

Maximum age: 48 Years

Healthy volunteers: No

Location
facility
Department of Anesthesiology, Aretaieio Hospital
Location Countries

Greece

Verification Date

August 2012

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Athens

Investigator full name: Argyro Fassoulaki

Investigator title: MD, PhD, DEAA

Keywords
Has Expanded Access No
Number Of Arms 1
Arm Group

Arm group label: Spinal Anesthesia with cerebral oxygen saturation monitoring

Arm group type: Other

Description: 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.

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov