Impedance Cardiography as Tool for Continuous Hemodynamic Monitoring During Cesarean Section

Study Overview
=================
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.

Official Title
-----------------
Impedance Cardiography as Tool for Continuous Hemodynamic Monitoring During Cesarean Section: Randomized, Prospective Double Blind Study

Conditions
-----------------
Cesarean Section Complications

Intervention / Treatment
-----------------
* Device: Impedance cardiography
* Diagnostic Test: Sensory levels
* Diagnostic Test: Motor block
* Diagnostic Test: Sensory level


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: 8 mg (2 mL) levobupivacaine<br>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<br>* hemodynamic variation measured by impedance cardiography in healthy pregnant undergoing to cesarean section treated with 8mg or 6mg of levobupivacaine<br>Diagnostic Test: Sensory levels<br>* Sensory levels are checked using ice test cold<br>Diagnostic Test: Motor block<br>* motor block is measured by modified Bromage scale<br>Diagnostic Test: Sensory level<br>* Sensory levels are checked using touch with alcohol puffs<br>|
| Active Comparator: 6 mg (1.6 mL) levobupivacaine<br>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<br>* hemodynamic variation measured by impedance cardiography in healthy pregnant undergoing to cesarean section treated with 8mg or 6mg of levobupivacaine<br>Diagnostic Test: Sensory levels<br>* Sensory levels are checked using ice test cold<br>Diagnostic Test: Motor block<br>* motor block is measured by modified Bromage scale<br>Diagnostic Test: Sensory level<br>* Sensory levels are checked using touch with alcohol puffs<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic continuous monitoring by impedance cardiography | Impedance cardiography as a tool for hemodynamic monitoring during cesarean section | intraoperative time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| onset of sensory block | onset time of sensory block after intrathecal levobupivacaine | intraoperative time | 
| offset of sensory block | offset time of sensory block after intrathecal levobupivacaine | intraoperative time | 
| onset of motor block | onset time of motor block after intrathecal levobupivacaine | intraoperative time | 
| offset of motor block | offset time of motor block after intrathecal levobupivacaine | intraoperative time |