Impedance Cardiography as Tool for Continuous Hemodynamic Monitoring During Cesarean Section

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03170427
• Other study ID #: 18/CE/2012
• Status: Completed
• Phase: N/A
• First received: May 23, 2017
• Last updated: October 20, 2017
• Start date: January 1, 2013
• Est. completion date: May 31, 2014

Study information

• Verified date: October 2017
• Source: University of Foggia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 31, 2014
• Est. primary completion date: January 1, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

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

Diagnostic Test:
• Sensory levels
Sensory levels are checked using ice test cold
• Motor block
motor block is measured by modified Bromage scale
• Sensory level
Sensory levels are checked using touch with alcohol puffs

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Foggia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemodynamic continuous monitoring by impedance cardiography	Impedance cardiography as a tool for hemodynamic monitoring during cesarean section	intraoperative time
Secondary	onset of sensory block	onset time of sensory block after intrathecal levobupivacaine	intraoperative time
Secondary	offset of sensory block	offset time of sensory block after intrathecal levobupivacaine	intraoperative time
Secondary	onset of motor block	onset time of motor block after intrathecal levobupivacaine	intraoperative time
Secondary	offset of motor block	offset time of motor block after intrathecal levobupivacaine	intraoperative time