AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in Canada

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.

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.

  1. 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)
  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.

  1. First posted11 Feb 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionMay 2010
  4. Study completionJun 2010

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in