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

Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669135
• Other study ID #: M19-12-21-2010
• Status: Completed
• Phase: N/A
• First received: August 8, 2012
• Last updated: August 17, 2012
• Start date: December 2010
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

Inclusion Criteria:

• Term healthy parturients

Exclusion Criteria:

• Body Mass Index > 35

• preeclampsia

• neurological,cardiovascular, respiratory disease

Study Design

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

Related Conditions & MeSH terms

• Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery

Intervention

Other:
• Spinal Anesthesia with cerebral oxygen saturation monitoring

Locations

Country	Name	City	State
Greece	Department of Anesthesiology, Aretaieio Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemodynamic changes (Changes in Blood Pressure (mmHg) and Heart rate (beats/min)	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	Yes
Primary	cerebral oxygen saturation of the right frontal lobe	Cerebral oxygen saturation is important as it may affect patient's outcome	Change from the performing of spinal anesthesia untill 1 minute after delivery	Yes
Secondary	cerebral oxygen saturation of the left frontal lobe	Cerebral oxygen saturation is important for patient's outcome	5, 10, 50 min after spinal,1 minute after delivery	Yes
Secondary	Thigh oxygen saturation	Thigh oxygen saturation may reflect blood redistribution due to spinal block	5, 10, 50 min after spinal, 1 minute after delivery	Yes
Secondary	Arterial Oxygenation	Changes in arterial oxygenation may reflect blood redistribution due to spinal block	5, 10, 50 min after spinal, 1 minute after delivery	Yes