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Impedance Cardiography as Tool for Continuous Hemodynamic Monitoring During Cesarean Section

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03170427
Enrollment
62
Registered
2017-05-31
Start date
2013-01-01
Completion date
2014-05-31
Last updated
2017-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications

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.

Interventions

hemodynamic variation measured by impedance cardiography in healthy pregnant undergoing to cesarean section treated with 8mg or 6mg of levobupivacaine

DIAGNOSTIC_TESTSensory levels

Sensory levels are checked using ice test cold

DIAGNOSTIC_TESTMotor block

motor block is measured by modified Bromage scale

DIAGNOSTIC_TESTSensory level

Sensory levels are checked using touch with alcohol puffs

Sponsors

University of Foggia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
hemodynamic continuous monitoring by impedance cardiographyintraoperative timeImpedance cardiography as a tool for hemodynamic monitoring during cesarean section

Secondary

MeasureTime frameDescription
offset of sensory blockintraoperative timeoffset time of sensory block after intrathecal levobupivacaine
onset of motor blockintraoperative timeonset time of motor block after intrathecal levobupivacaine
onset of sensory blockintraoperative timeonset time of sensory block after intrathecal levobupivacaine
offset of motor blockintraoperative timeoffset time of motor block after intrathecal levobupivacaine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026