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Impedance Cardiography as Tool for Continuous Hemodynamic Monitoring During Cesarean Section

NCT ID: NCT03170427

Last Updated: 2017-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-01

Study Completion Date

2014-05-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type SHAM_COMPARATOR

Impedance cardiography

Intervention Type DEVICE

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

Sensory levels

Intervention Type DIAGNOSTIC_TEST

Sensory levels are checked using ice test cold

Motor block

Intervention Type DIAGNOSTIC_TEST

motor block is measured by modified Bromage scale

Sensory level

Intervention Type DIAGNOSTIC_TEST

Sensory levels are checked using touch with alcohol puffs

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

Group Type ACTIVE_COMPARATOR

Impedance cardiography

Intervention Type DEVICE

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

Sensory levels

Intervention Type DIAGNOSTIC_TEST

Sensory levels are checked using ice test cold

Motor block

Intervention Type DIAGNOSTIC_TEST

motor block is measured by modified Bromage scale

Sensory level

Intervention Type DIAGNOSTIC_TEST

Sensory levels are checked using touch with alcohol puffs

Interventions

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Impedance cardiography

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

Intervention Type DEVICE

Sensory levels

Sensory levels are checked using ice test cold

Intervention Type DIAGNOSTIC_TEST

Motor block

motor block is measured by modified Bromage scale

Intervention Type DIAGNOSTIC_TEST

Sensory level

Sensory levels are checked using touch with alcohol puffs

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Foggia

OTHER

Sponsor Role lead

Responsible Party

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Cotoia Antonella

researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 29587655 (View on PubMed)

Other Identifiers

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18/CE/2012

Identifier Type: -

Identifier Source: org_study_id