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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.375% ropivacaine | Active Comparator | 0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia |
|
| 0.75% ropivacaine | Active Comparator | 0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia |
|
| 0.2% ropivacaine | Active Comparator | 0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.75% ropivacaine concentration | Drug | 0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia |
|
| 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 |
| 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. |
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Inclusion Criteria: all of the followings needed.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyeon Jeong Lee, PhD, MD | Dept. of Anesthesia, Pusan National University, School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | 626770 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29145824 | Derived | Hong JM, Lee HJ, Oh YJ, Cho AR, Kim HJ, Lee DW, Do WS, Kwon JY, Kim H. Observations on significant hemodynamic changes caused by a high concentration of epidurally administered ropivacaine: correlation and prediction study of stroke volume variation and central venous pressure in thoracic epidural anesthesia. BMC Anesthesiol. 2017 Nov 16;17(1):153. doi: 10.1186/s12871-017-0444-x. |
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| 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 |
|
| during 1hour after administration of epidural drug dosing |