Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters

Pusan National University Hospital120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

120

Conditions

Epidural Anesthesia Ropivacaine Concentration Hemodynamics

Interventions

0.75% ropivacaine concentrationDRUG

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

0.375% ropivacaine concentrationDRUG

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

0.2% ropivacaine concentrationDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Pusan National University Yangsan Hospital

Yangsan, South Korea

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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