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Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters (PNU)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01559285
First Posted: March 21, 2012
Last Update Posted: August 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hyeon-Jeong Lee, Pusan National University Hospital
  Purpose
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.

Condition Intervention Phase
Epidural Anesthesia Ropivacaine Concentration Hemodynamics Drug: 0.75% ropivacaine concentration Drug: 0.375% ropivacaine concentration Drug: 0.2% ropivacaine concentration Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters

Resource links provided by NLM:


Further study details as provided by Hyeon-Jeong Lee, Pusan National University Hospital:

Primary Outcome Measures:
  • hemodynamic changes depends on the concentration of ropivacaine [ Time Frame: during 1hour after administration of epidural drug dosing ]
    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.


Secondary Outcome Measures:
  • Age based hemodynamic changes depends on the concentration of ropivacaine [ Time Frame: during 1hour after administration of epidural drug dosing ]

    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.



Enrollment: 120
Actual Study Start Date: November 16, 2011
Study Completion Date: April 19, 2013
Primary Completion Date: April 19, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 0.375% ropivacaine
0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia
Drug: 0.375% ropivacaine concentration
0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia
Active Comparator: 0.75% ropivacaine
0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia
Drug: 0.75% ropivacaine concentration
0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia
Active Comparator: 0.2% ropivacaine
0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia
Drug: 0.2% ropivacaine concentration
0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559285


Locations
Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan, Korea, Republic of, 626770
Sponsors and Collaborators
Pusan National University Hospital
Investigators
Principal Investigator: Hyeon Jeong Lee, PhD, MD Dept. of Anesthesia, Pusan National University, School of Medicine
  More Information

Responsible Party: Hyeon-Jeong Lee, Assisstant Professor, Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT01559285     History of Changes
Other Study ID Numbers: PNU05-2011-054
First Submitted: March 19, 2012
First Posted: March 21, 2012
Last Update Posted: August 29, 2017
Last Verified: August 2017

Keywords provided by Hyeon-Jeong Lee, Pusan National University Hospital:
epidural, local, ropivacaine
epidural administration
stroke volume variability

Additional relevant MeSH terms:
Anesthetics
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents