Epidural Anesthesia, Hemodynamics, Ropivacaine Concentration
Conditions
Keywords
epidural, local, ropivacaine, epidural administration, stroke volume variability
Brief summary
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
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.
Interventions
DRUG0.75% ropivacaine concentration
0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia
DRUG0.375% ropivacaine concentration
0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia
DRUG0.2% ropivacaine concentration
0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia
Sponsors
Pusan National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hemodynamic changes depends on the concentration of ropivacaine | 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
| Measure | Time frame | Description |
|---|---|---|
| Age based hemodynamic changes depends on the concentration of ropivacaine | 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. |
Countries
South Korea
Outcome results
None listed