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

NCT01067560 | Completed

• 1 other identifier: H09-02574
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anesthesia

Keywords

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

Outcome Measures

Primary Outcomes (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

  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).

  1 day

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Parturients undergoing Cesarean delivery under spinal anesthesia at BC Women's Hospital

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Women's Hospital, Department of Anesthesia

Vancouver, British Columbia, V6H3N1, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, CSF

Study Officials

• Giselle Villar, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 11, 2010
• Study Start: January 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 10, 2010

Record last verified: 2010-11

Locations

CA (1)