Clinical Trial: Cerebral Near-infrared Spectroscopy (NIRS) Monitoring Throughout Caesarean Deliveries
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Cerebral Near-infrared Spectroscopy (NIRS) Monitoring Throughout Caesarean Deliveries
Brief Summary:
In this study the investigator would like to examine hemodynamic cerebral blood flow and brain function by the use of Invos cerebral oximetry in women undergoing cesarean section delivery.
This study is a purely observational study, it will not have any clinical intervention nor will it interfere with standard cesarean delivery protocols in any way.
The investigator's primary objective is to evaluate how anesthesia influences cerebral blood flow perfusion during cesarean section deliveries.
Detailed Summary:
This is a prospective, single center study which will be conducted at the Rabin Medical Center (Beilinson Campus), Petach Tikva, Israel, a tertiary university hospital. The Institutional Review Board has approved this study.
Two hundred women undergoing cesarean sections will be enrolled after filling out an informed consent form.
Cerebral blood flow perfusion will be monitored preoperatively, intraoperativly and half an hour postoperativly, for all enrolled participants using INVOS Cerebral Oximetry.
Preoperative data will be compared to intraoperative data and analyzed in order to evaluate the dynamic cerebral oxygen and blood perfusion changes in women undergoing cesarean sections.
Sponsor: Rabin Medical Center
Current Primary Outcome: measure the cerebral perfusion in participants undergoing cesarean sections deliveries, under spinal anesthesia, epidural anesthesia, and general anesthesia [ Time Frame: The average time frame is 24 hours. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Rabin Medical Center
Dates:
Date Received: June 11, 2015
Date Started: April 2015
Date Completion:
Last Updated: May 8, 2016
Last Verified: May 2016
