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

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

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Device: Impedance cardiography; Diagnostic test: Sensory levels; Diagnostic test: Motor block; Diagnostic test: Sensory level

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 8 mg (2 mL) levobupivacaine; 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; 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; Diagnostic test: Motor block; motor block is measured by modified Bromage scale; Diagnostic test: Sensory level; Sensory levels are checked using touch with alcohol puffs
Active Comparator: 6 mg (1.6 mL) levobupivacaine; 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; 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; Diagnostic test: Motor block; motor block is measured by modified Bromage scale; Diagnostic test: Sensory level; Sensory levels are checked using touch with alcohol puffs

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

Collaborators and Investigators

• Sponsor: University of Foggia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): May 31, 2014

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): October 23, 2017
• Last Update Submitted That Met QC Criteria: October 20, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 18/CE/2012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No