NCT03170427

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2014

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
Last Updated

October 23, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

May 23, 2017

Last Update Submit

October 20, 2017

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

  • hemodynamic continuous monitoring by impedance cardiography

    Impedance cardiography as a tool for hemodynamic monitoring during cesarean section

    intraoperative time

Secondary Outcomes (4)

  • onset of sensory block

    intraoperative time

  • offset of sensory block

    intraoperative time

  • onset of motor block

    intraoperative time

  • offset of motor block

    intraoperative time

Study Arms (2)

8 mg (2 mL) levobupivacaine

SHAM COMPARATOR

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 cardiographyDiagnostic Test: Sensory levelsDiagnostic Test: Motor blockDiagnostic Test: Sensory level

6 mg (1.6 mL) levobupivacaine

ACTIVE COMPARATOR

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 cardiographyDiagnostic Test: Sensory levelsDiagnostic Test: Motor blockDiagnostic Test: Sensory level

Interventions

Impedance cardiographyDEVICE

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

6 mg (1.6 mL) levobupivacaine8 mg (2 mL) levobupivacaine
Sensory levelsDIAGNOSTIC_TEST

Sensory levels are checked using ice test cold

6 mg (1.6 mL) levobupivacaine8 mg (2 mL) levobupivacaine
Motor blockDIAGNOSTIC_TEST

motor block is measured by modified Bromage scale

6 mg (1.6 mL) levobupivacaine8 mg (2 mL) levobupivacaine
Sensory levelDIAGNOSTIC_TEST

Sensory levels are checked using touch with alcohol puffs

6 mg (1.6 mL) levobupivacaine8 mg (2 mL) levobupivacaine

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29587655DERIVED

MeSH Terms

Interventions

Cardiography, Impedance

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisPlethysmography, ImpedancePlethysmography

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 31, 2017

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

May 31, 2014

Last Updated

October 23, 2017

Record last verified: 2017-10