Impedance Cardiography as Tool for Continuous Hemodynamic Monitoring During Cesarean Section

Overview

Impedance Cardiography (ICG) is a non-invasive tool for continuous hemodynamic monitoring. Aims of our study is to assess the utility of ICG to evaluate the hemodynamic impact of 6 mg (GL6) vs 8 mg (GL8) levobupivacaine combined with fentanyl in healthy patients undergoing elective cesarean section; secondary, to compare the duration and quality of analgesia and anesthesia

Full Title of Study: “Impedance Cardiography as Tool for Continuous Hemodynamic Monitoring During Cesarean Section: Randomized, Prospective Double Blind Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Participant)
  • Study Primary Completion Date: January 1, 2014

Detailed Description

On arrival in the recovery room the ICG non-invasive blood pressure cuff will be placed on the left arm, two sensors will be placed above the clavicle on each side of the neck, and two sensors will bw placed on either side of the thorax at midaxillary line corresponding to the level of the xiphoid process. Using a computer- generated sequence of numbers, patients will be randomly allocated in one of the two groups: 6 mg (1.6 mL) levobupivacaine + 20 µg fentanyl (GL6 group) or 8 mg (2 mL) levobupivacaine + 20 µg fentanyl (GL8 group). Continuous spinal epidural anesthesia (CSE) will be performed with patient in sitting position: a 18-gauge Tuohy needle will be inserted into the L2-L3 interspace using the loss of resistance of saline technique to identify the epidural space; a 27-gauge Withacre spinal needle will be then placed through the Tuohy needle until the dura mater wwill be punctured and isobaric undiluted levobupivacaine plus 20 µg fentanyl was administered. Afterwards, an epidural catheter (Espocan, B.Braun, Melsungen, Germany) wwill be inserted 4 cm into the epidural space.

Interventions

  • Device: Impedance cardiography
    • hemodynamic variation measured by impedance cardiography in healthy pregnant undergoing to cesarean section treated with 8mg or 6mg of levobupivacaine
  • Diagnostic Test: Sensory levels
    • Sensory levels are checked using ice test cold
  • Diagnostic Test: Motor block
    • motor block is measured by modified Bromage scale
  • Diagnostic Test: Sensory level
    • Sensory levels are checked using touch with alcohol puffs

Arms, Groups and Cohorts

  • Sham Comparator: 8 mg (2 mL) levobupivacaine
    • 8mg (2ml) levobupivacaine plus 20 µg fentanyl will be given intrathecally by spinal anesthesia. The impendance cardiography, the sensory and motor block will be monitored
  • Active Comparator: 6 mg (1.6 mL) levobupivacaine
    • 6mg (1.6ml) levobupivacaine plus 20 µg fentanyl will be given intrathecally by spinal anesthesia. The impendance cardiography, the sensory and motor block will be monitored

Clinical Trial Outcome Measures

Primary Measures

  • hemodynamic continuous monitoring by impedance cardiography
    • Time Frame: intraoperative time
    • Impedance cardiography as a tool for hemodynamic monitoring during cesarean section

Secondary Measures

  • onset of sensory block
    • Time Frame: intraoperative time
    • onset time of sensory block after intrathecal levobupivacaine
  • offset of sensory block
    • Time Frame: intraoperative time
    • offset time of sensory block after intrathecal levobupivacaine
  • onset of motor block
    • Time Frame: intraoperative time
    • onset time of motor block after intrathecal levobupivacaine
  • offset of motor block
    • Time Frame: intraoperative time
    • offset time of motor block after intrathecal levobupivacaine

Participating in This Clinical Trial

Inclusion Criteria

  • pregnant undergoing elective Caesarean delivery at term of singleton pregnancy, with American Society of Anesthesiologists physical status of class I or II, without preeclampsia or diabetes, Exclusion Criteria:

  • Patient with a known allergy to amide local anesthetics and other drugs, with BMI≥40 kg/m2, cardiologic or systemic disease, in treatment with antihypertensive or anticoagulant

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Foggia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Cotoia Antonella, researcher – University of Foggia

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