Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters

Conditions
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Epidural Anesthesia, Ropivacaine Concentration, Hemodynamics

Intervention / Treatment
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* Drug: 0.75% ropivacaine concentration
* Drug: 0.375% ropivacaine concentration
* Drug: 0.2% ropivacaine concentration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.375% ropivacaine<br>0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia | Drug: 0.375% ropivacaine concentration<br>* 0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia<br>|
| Active Comparator: 0.75% ropivacaine<br>0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia | Drug: 0.75% ropivacaine concentration<br>* 0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia<br>|
| Active Comparator: 0.2% ropivacaine<br>0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia | Drug: 0.2% ropivacaine concentration<br>* 0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | during 1hour after administration of epidural drug dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural, local, ropivacaine, epidural administration, stroke volume variability