An interventional study of Impedance cardiography and Sensory levels in Cesarean Section Complications, sponsored by University of Foggia. Completed. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-10-23.
Sponsored by University of Foggia · Not applicable, Interventional, and Diagnostic
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
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.
University of Foggia is the lead sponsor of 35 studies on the registry; 4 are open to participants now.
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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
Device: Impedance cardiography · Diagnostic Test: Sensory levels · Diagnostic Test: Motor block · Diagnostic Test: Sensory level
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
Device: Impedance cardiography · Diagnostic Test: Sensory levels · Diagnostic Test: Motor block · Diagnostic Test: Sensory level
hemodynamic variation measured by impedance cardiography in healthy pregnant undergoing to cesarean section treated with 8mg or 6mg of levobupivacaine
Sensory levels are checked using ice test cold
motor block is measured by modified Bromage scale
Sensory levels are checked using touch with alcohol puffs
hemodynamic continuous monitoring by impedance cardiography
Impedance cardiography as a tool for hemodynamic monitoring during cesarean section
Time frame: intraoperative time
onset of sensory block
onset time of sensory block after intrathecal levobupivacaine
Time frame: intraoperative time
offset of sensory block
offset time of sensory block after intrathecal levobupivacaine
Time frame: intraoperative time
onset of motor block
onset time of motor block after intrathecal levobupivacaine
Time frame: intraoperative time
offset of motor block
offset time of motor block after intrathecal levobupivacaine
Time frame: intraoperative time
No study locations are listed for this record.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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