Impedance Cardiography as Tool for Continuous Hemodynamic Monitoring During Cesarean Section

Not Applicable

Completed

• Conditions: Cesarean Section Complications
• Interventions: Device: Impedance cardiography; Diagnostic Test: Sensory levels; Diagnostic Test: Motor block; Diagnostic Test: Sensory level

• Registration Number: NCT03170427
• Lead Sponsor: University of Foggia

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2014-01-01
• Study Completion: 2014-05-31
• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-31
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-20
• Last Update Posted: 2017-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
8 mg (2 mL) levobupivacaine	Sensory levels	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
6 mg (1.6 mL) levobupivacaine	Impedance cardiography	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
8 mg (2 mL) levobupivacaine	Sensory level	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
8 mg (2 mL) levobupivacaine	Impedance cardiography	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
6 mg (1.6 mL) levobupivacaine	Motor block	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
6 mg (1.6 mL) levobupivacaine	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
8 mg (2 mL) levobupivacaine	Motor block	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
6 mg (1.6 mL) levobupivacaine	Sensory levels	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

Primary Outcome Measures

Name	Time	Method
hemodynamic continuous monitoring by impedance cardiography	intraoperative time	Impedance cardiography as a tool for hemodynamic monitoring during cesarean section

Secondary Outcome Measures

Name	Time	Method
onset of sensory block	intraoperative time	onset time of sensory block after intrathecal levobupivacaine
offset of motor block	intraoperative time	offset time of motor block after intrathecal levobupivacaine
offset of sensory block	intraoperative time	offset time of sensory block after intrathecal levobupivacaine
onset of motor block	intraoperative time	onset time of motor block after intrathecal levobupivacaine