Clinical trial NCT03170427: Impedance Cardiography as Tool for Continuous Hemodynamic Monitoring During Cesarean Section
Official title: Impedance Cardiography as Tool for Continuous Hemodynamic Monitoring During Cesarean Section: Randomized, Prospective Double Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: University of Foggia
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: hemodynamic continuous monitoring by impedance cardiography
timeFrame: intraoperative time
Secondary outcomes:
measure: onset of sensory block
timeFrame: intraoperative time
measure: offset of sensory block
timeFrame: intraoperative time
measure: onset of motor block
timeFrame: intraoperative time
measure: offset of motor block
timeFrame: intraoperative time
Other outcomes:
Locations:
Study officials:
References:
citation: D'Ambrosio A, Cotoia A, Beck R, Salatto P, Zibar L, Cinnella G. Impedance cardiography as tool for continuous hemodynamic monitoring during cesarean section: randomized, prospective double blind study. BMC Anesthesiol. 2018 Mar 27;18(1):32. doi: 10.1186/s12871-018-0498-4.