Measuring Cerebrospinal Fluid (CSF) Glucose Levels in Patients Under Going an Elective Cesarean Section With Spinal Anesthesia
| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | February 9, 2010 | ||||||||||||||||
| Last Updated Date | November 8, 2010 | ||||||||||||||||
| Start Date ICMJE | January 2010 | ||||||||||||||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] | ||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT01067560 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Measuring Cerebrospinal Fluid (CSF) Glucose Levels in Patients Under Going an Elective Cesarean Section With Spinal Anesthesia | ||||||||||||||||
| Official Title ICMJE | Measurement of CSF Glucose Levels Using Three Different Glucose Meters in Parturients Undergoing Spinal Anesthesia for Elective Cesarean Section | ||||||||||||||||
| Brief Summary | This study will determine the level of glucose (sugar) in the CSF (fluid that surrounds the spinal cord) in 30 subjects having spinal anesthesia for cesarean section using a bedside glucose meter. Spinal anesthesia is done by injecting drugs through a needle into the CSF. Subjects will have 1/10 tsp of CSF removed at the time of spinal anesthesia to measure the level of glucose. Glucose meters measure glucose, usually in the blood, and they can be used in the operating room. This study will see whether a glucose meter will easily measure the level of glucose in CSF. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Observational | ||||||||||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||||||||||
| Target Follow-Up Duration | Not Provided | ||||||||||||||||
| Biospecimen | Retention: Samples With DNA Description: Whole blood, CSF |
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| Sampling Method | Probability Sample | ||||||||||||||||
| Study Population | Parturients undergoing Cesarean delivery under spinal anesthesia at BC Women's Hospital |
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| Condition ICMJE | Spinal Anesthesia | ||||||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||||||||||
| Publications * | Not Provided | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||
| Enrollment ICMJE | 30 | ||||||||||||||||
| Completion Date | June 2010 | ||||||||||||||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||||||||||
| Ages | 19 Years to 45 Years | ||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | Canada | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT01067560 | ||||||||||||||||
| Other Study ID Numbers ICMJE | H09-02574 | ||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||
| Responsible Party | Dr. Giselle Villar, University of British Columbia | ||||||||||||||||
| Study Sponsor ICMJE | University of British Columbia | ||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of British Columbia | ||||||||||||||||
| Verification Date | November 2010 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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