Measuring Cerebrospinal Fluid (CSF) Glucose Levels in Patients Under Going an Elective Cesarean Section With Spinal Anesthesia
|ClinicalTrials.gov Identifier: NCT01067560|
Recruitment Status : Completed
First Posted : February 11, 2010
Last Update Posted : November 10, 2010
|Condition or disease|
Detailed Description Spinal anesthesia consists of putting drugs into the cerebrospinal fluid (CSF), the fluid that surrounds the spinal cord. This allows the subject to be awake but "numb" from the chest down during your operation. Spinal anesthesia is done by inserting a small needle (spinal needle) in the subject's back into the space (subarachnoid space) containing the CSF. Once the spinal needle is in the subarachnoid space a small amount of fluid (CSF) is seen coming out of the spinal needle, confirming that the needle is in the right space. The anesthesiologist then injects local anesthetic into the CSF to freeze or numb the area for your surgery and some pain medication, such as morphine, to relieve pain after the operation.
CSF contains glucose (sugar) and the presence of glucose in the fluid that comes out of a spinal needle will confirm that the fluid is CSF. If spinal anesthesia is used for cesarean section following failed epidural anesthesia (may happen in women who had an epidural for labor pain relief who then need a cesarean section) it may be difficult to tell whether the fluid that comes out of the spinal needle is CSF or local anesthetic used for the epidural. In other words, the needle may be in the epidural space instead of the subarachnoid space and so the spinal anesthetic would not work. A simple bedside test to confirm that the fluid is CSF could potentially prevent this situation. Local anesthetic does not contain glucose so testing the fluid for glucose could help determine if the needle is in the proper space for spinal anesthesia.
The study will determine the normal levels of CSF glucose using three different glucose meters (Nova Stat Strip, Abbott Precision Xtra and Roche Accucheck Inform 2 which are bedside devices that measure glucose). A glucose meter is used by people with diabetes to check their blood sugar levels using a drop of their blood. The results of this study will hopefully provide the basis for a further study that would look at whether it is possible to distinguish CSF from epidural fluid when spinal anesthesia is done following a failed epidural anesthetic. This could help prevent failures of spinal anesthesia in that situation.
This is a prospective, observational study.
The Cesarean Section and spinal anesthesia will continue as per usual practice at BCWH. Consenting subjects will receive the same drugs and all aspects of the anesthetic care will be the same except for two differences. The first, is that the anesthesiologist will collect a very small amount of CSF (0.5 mL which is 1/10 of a teaspoon) to measure the amount of glucose. This testing will be done in the operating room with the three glucose meters (Nova Stat Strip, Abbott Precision Xtra and Roche Accucheck Inform 2) and in the laboratory (using one of the two machines: 1)Vitros 9 or 2)Vitros 5,1 FS). Secondly, blood sugar level will be tested by taking up to three drops of blood from a pinprick in the subject's toe to compare with the CSF glucose level.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Measurement of CSF Glucose Levels Using Three Different Glucose Meters in Parturients Undergoing Spinal Anesthesia for Elective Cesarean Section|
|Study Start Date :||January 2010|
|Primary Completion Date :||May 2010|
|Study Completion Date :||June 2010|
- Primary Outcome is to establish reference ranges for glucose in CSF in parturients undergoing Cesarean delivery under spinal anesthesia using glucose meters currently undergoing testing at BC Women's Hospital [ Time Frame: 1 day ]
- Our secondary objective is to compare the performance of glucose meters (bed side testing devices for glucose) to measure CSF glucose via three glucose meters (Nova Stat Strip, Abbott Precision Xtra and Roche Accucheck Inform 2). [ Time Frame: 1 day ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067560
|Canada, British Columbia|
|BC Women's Hospital, Department of Anesthesia|
|Vancouver, British Columbia, Canada, V6H3N1|
|Principal Investigator:||Giselle Villar, MD||University of British Columbia|
|Study Director:||Anne Catherine Halstead, MD, FRCPC||University of British Columbia|
|Study Director:||Simrat Saran, MD, BSc||University of British Columbia|
|Study Director:||Steve Thomas, MBChB, FRCA||University of British Columbia|