NCT01559285

Brief Summary

In this trial, the investigators intend to examine whether the concentration of local anesthetics during epidural analgesia could be modulating factor for change of hemodynamics in patients undergoing major upper abdominal surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

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

November 16, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2013

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

1.4 years

First QC Date

March 19, 2012

Last Update Submit

August 28, 2017

Conditions

Epidural AnesthesiaRopivacaine ConcentrationHemodynamics

Keywords

epidural, local, ropivacaineepidural administrationstroke volume variability

Outcome Measures

Primary Outcomes (1)

  • hemodynamic changes depends on the concentration of ropivacaine

    Systolic blood pressure, diastolic blood pressure, MAP, HR, stroke volume, stroke volume, stroke volume index, stroke volume variation, cardiac output, and cardiac index were continuously measured at 5 minute intervals during 1 hour.

    during 1hour after administration of epidural drug dosing

Secondary Outcomes (1)

  • Age based hemodynamic changes depends on the concentration of ropivacaine

    during 1hour after administration of epidural drug dosing

Study Arms (3)

0.375% ropivacaine

ACTIVE COMPARATOR

0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia

Drug: 0.375% ropivacaine concentration

0.75% ropivacaine

ACTIVE COMPARATOR

0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia

Drug: 0.75% ropivacaine concentration

0.2% ropivacaine

ACTIVE COMPARATOR

0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia

Drug: 0.2% ropivacaine concentration

Interventions

0.75% ropivacaine concentrationDRUG

0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia

0.75% ropivacaine
0.375% ropivacaine concentrationDRUG

0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia

0.375% ropivacaine
0.2% ropivacaine concentrationDRUG

0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia

0.2% ropivacaine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I or II patients
  • to 65 years old
  • undergoing major upper abdominal surgery
  • planned combined thoracic epidural analgesia and general anesthesia

You may not qualify if:

  • any contraindication to epidural analgesia
  • allergy to local anesthetics of the amide type
  • communication difficulties that would prevent reliable assessment
  • known significant cardiac or respiratory disease
  • pregnant
  • patients who were not in cardiac sinus rhythm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, 626770, South Korea

Location

Related Publications (1)

  • Hong JM, Lee HJ, Oh YJ, Cho AR, Kim HJ, Lee DW, Do WS, Kwon JY, Kim H. Observations on significant hemodynamic changes caused by a high concentration of epidurally administered ropivacaine: correlation and prediction study of stroke volume variation and central venous pressure in thoracic epidural anesthesia. BMC Anesthesiol. 2017 Nov 16;17(1):153. doi: 10.1186/s12871-017-0444-x.

    PMID: 29145824DERIVED

Study Officials

  • Hyeon Jeong Lee, PhD, MD

    Dept. of Anesthesia, Pusan National University, School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor

Study Record Dates

First Submitted

March 19, 2012

First Posted

March 21, 2012

Study Start

November 16, 2011

Primary Completion

April 19, 2013

Study Completion

April 19, 2013

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations

KR(1)