Spinal AnesthesiaNCT01067560
Measuring Cerebrospinal Fluid (CSF) Glucose Levels in Patients Under Going an Elective Cesarean Section With Spinal Anesthesia
An observational study of Spinal Anesthesia, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Anesthesia
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Parturients undergoing Cesarean delivery under spinal anesthesia at BC Women's Hospital
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Women's Hospital, Department of Anesthesia
Vancouver, British Columbia, V6H3N1
About this study
Official title: Measurement of CSF Glucose Levels Using Three Different Glucose Meters in Parturients Undergoing Spinal Anesthesia for Elective Cesarean Section
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.
Read the 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.
- Conditions
- Spinal Anesthesia
- Keywords
- Glucose, CSF, Cesarean section, spinal anesthesia, Nova Stat Strip, Abbott Precision Xtra, Roche Accucheck Inform 2
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (1)
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).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Giselle Villar, MD, Principal investigator, University of British ColumbiaAnne Catherine Halstead, MD, FRCPC, Study director, University of British ColumbiaSimrat Saran, MD, BSc, Study director, University of British ColumbiaSteve Thomas, MBChB, FRCA, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067560
- Sponsor's protocol ID
- H09-02574
- Status last verified
- Nov 2010
- First submitted
- 9 Feb 2010
- Last updated
- 10 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of CSF Glucose Levels Using Three Different Glucose Meters in Parturients Undergoing Spinal Anesthesia for Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT01067560
- Acronym / sponsor ID
- H09-02574
- Conditions
- Spinal Anesthesia
- Keywords
- Glucose, CSF, Cesarean section, spinal anesthesia, Nova Stat Strip, Abbott Precision Xtra, Roche Accucheck Inform 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 11 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Parturients undergoing Cesarean delivery under spinal anesthesia at BC Women's Hospital
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giselle Villar, MD principal investigator
University of British Columbia
Anne Catherine Halstead, MD, FRCPC study director
University of British Columbia
Simrat Saran, MD, BSc study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Anesthesia, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2010.