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

This study is currently recruiting participants.
Verified January 2013 by Pusan National University Hospital
Sponsor:
Information provided by (Responsible Party):
Hyeon-Jeong Lee, Pusan National University Hospital
ClinicalTrials.gov Identifier:
NCT01559285
First received: March 19, 2012
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pusan National University Hospital:

Primary Outcome Measures:
  • measure of hemodynamics [ Time Frame: during 1hour after administration of epidural drug dosing ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 120
Study Start Date: November 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559285

Contacts
Contact: Hyeon Jeong Lee, MD, PhD 82-51-240-7399 lhjksk@pusan.ac.kr

Locations
Korea, Republic of
Pusan National University Yangsan Hospital Recruiting
Yangsan, Korea, Republic of, 626770
Contact: Hyeon Jeong Lee, MD, PhD     82-10-7680-7689     lhjksk@pusan.ac.kr    
Sub-Investigator: Ji Uk Yoon, MD            
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

No publications provided

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
Study First Received: March 19, 2012
Last Updated: January 24, 2013
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013