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Completed

NCT Number: NCT01559285

Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters

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.

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Key information

Conditions

Epidural Anesthesia Hemodynamics Ropivacaine Concentration

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pusan National University Yangsan Hospital

Yangsan, 626770, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.75% ropivacaine concentration

Drug

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

0.375% ropivacaine concentration

Drug

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

0.2% ropivacaine concentration

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Pusan National University Hospital

Other

Registry information

Acronym: PNU

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 21, 2012
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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