Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- hemodynamic changes depends on the concentration of ropivacaine
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •patients who were not in cardiac sinus rhythm
Arms & Interventions
0.375% ropivacaine
0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia
Intervention: 0.375% ropivacaine concentration (Drug)
0.75% ropivacaine
0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia
Intervention: 0.75% ropivacaine concentration (Drug)
0.2% ropivacaine
0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia
Intervention: 0.2% ropivacaine concentration (Drug)
Outcomes
Primary Outcomes
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
- Age based hemodynamic changes depends on the concentration of ropivacaine(during 1hour after administration of epidural drug dosing)
Investigators
Hyeon-Jeong Lee
Assisstant Professor
Pusan National University Hospital