Measuring Cerebrospinal Fluid (CSF) Glucose Levels in Patients Under Going an Elective Cesarean Section With Spinal Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Anesthesia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Glucose CSF Cesarean section, spinal anesthesia Nova Stat Strip Abbott Precision Xtra Roche Accucheck Inform 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy women (American Society of Anesthesiologists (ASA) 1 or 2 classification) with a singleton pregnancy who are undergoing Cesarean section under spinal anesthesia.
* Age 19 years or older
* Understand written and oral English

Exclusion Criteria

* Women who are having an emergency Cesarean section
* Women who are having epidural, combined spinal epidural or general anesthesia
* Women who have a contraindication to spinal anesthesia
* Women who are less than 19 years of age
* Women with an abnormality of glucose metabolism such as diabetes mellitus, gestational diabetes
* Women receiving dextrose intravenously prior to their surgery
* Women in whom technical problems are anticipated during insertion of the spinal (such as scoliosis) ot who may have a hematological abnormality o If there is technical difficulty during insertion of the spinal there is an increased chance of trauma, resulting in blood entering the CSF (bloody tap). This could potentially be a source of glucose. Women with a hematological abnormality are at increased of bleeding which may increase the chance of blood in the CSF.

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.