Impedance Cardiography as Tool for Continuous Hemodynamic Monitoring During Cesarean Section: Randomized, Prospective Double Blind Study
| Registry | NCT03170427 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, diagnostic |
| Enrollment | 62 (Actual) |
| Sponsor | University of Foggia (Other) |
| Conditions | Cesarean Section Complications |
| Interventions | Impedance cardiography, Sensory levels, Motor block, Sensory level (Device, diagnostic test) |
| Dates | start 2013-01-01, primary completion 2014-01-01, completion 2014-05-31, first posted 2017-05-31, last updated 2017-10-23 |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 8 mg (2 mL) levobupivacaine | Sham comparator | Device: Impedance cardiography; Diagnostic Test: Sensory levels; Diagnostic Test: Motor block; Diagnostic Test: 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 |
| 6 mg (1.6 mL) levobupivacaine | Active comparator | 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 |
Sex: Female, ages: 18 Years to 45 Years
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