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CompletedNCT01559285PNUUpdated Aug 29, 2017

Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters

A Phase 4 interventional study of 0.75% ropivacaine concentration and 0.375% ropivacaine concentration in Epidural Anesthesia, Ropivacaine Concentration and Hemodynamics, sponsored by Pusan National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-08-29.

Sponsored by Pusan National University Hospital · Phase 4, Interventional, and Basic science

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Nov 2011, registered Mar 2012).
Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

One hundred and twenty patients scheduled for major abdominal surgery under TEA combined general anesthesia were randomized in a double-blinded method to receive one of three different concentration study solutions in 8 ml of volume after the induction of anesthesia: 0.75% ropivacaine (60 mg), 0.375% ropivacaine (30 mg), or 0.2% ropivacane (16 mg).

In each group, the patients were divided into two subgroups at the age of 60 to perform age based analysis. The acquired hemodynamic data after administration of epidural loading dose were compared and analyzed between young and elderly groups in each group.

02

Conditions studied

  • Epidural Anesthesia
  • Ropivacaine Concentration
  • Hemodynamics

Keywords

  • epidural, local, ropivacaine
  • epidural administration
  • stroke volume variability
03

In context

Lead sponsor

Pusan National University Hospital is the lead sponsor of 78 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: all of the followings needed.

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

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    0.375% ropivacaine

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

    Drug: 0.375% ropivacaine concentration

  • Active comparator
    0.75% ropivacaine

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

    Drug: 0.75% ropivacaine concentration

  • Active comparator
    0.2% ropivacaine

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

    Drug: 0.2% ropivacaine concentration

Interventions

  • Drug0.75% ropivacaine concentration

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

  • Drug0.375% ropivacaine concentration

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

  • Drug0.2% ropivacaine concentration

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

06

What researchers measure

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.

    Time frame: during 1hour after administration of epidural drug dosing

Secondary outcomes

  1. Age based hemodynamic changes depends on the concentration of ropivacaine

    In each group, the patients were divided into two subgroups at the age of 60 to perform age based analysis. The acquired hemodynamic data after administration of epidural loading dose were compared and analyzed between young and elderly groups in each group. 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.

    Time frame: during 1hour after administration of epidural drug dosing

07

Study locations

1 site
  • Pusan National University Yangsan Hospital
    Yangsan, 626770, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 29145824 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01559285
Lead sponsor
Pusan National University Hospital
Responsible party
Hyeon-Jeong Lee (Assisstant Professor, Pusan National University Hospital) — Principal investigator
First posted
Mar 21, 2012
Start date
Nov 16, 2011
Primary completion
Apr 19, 2013
Completion
Apr 19, 2013
Last update
Aug 29, 2017

Study contacts

Hyeon Jeong Lee, PhD, MD
principal investigator · Dept. of Anesthesia, Pusan National University, School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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