Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters

Phase 4

Completed

• Conditions: Epidural Anesthesia; Hemodynamics; Ropivacaine Concentration
• Interventions: Drug: 0.75% ropivacaine concentration; Drug: 0.2% ropivacaine concentration; Drug: 0.375% ropivacaine concentration

• Registration Number: NCT01559285
• Lead Sponsor: Pusan National University Hospital

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 Timeline

• Study Start: 2011-11-16
• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-21
• Primary Completion: 2013-04-19
• Study Completion: 2013-04-19
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.75% ropivacaine	0.75% ropivacaine concentration	0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia
0.2% ropivacaine	0.2% ropivacaine concentration	0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia
0.375% ropivacaine	0.375% ropivacaine concentration	0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Korea, Republic of