Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-16

Study Completion Date

2013-04-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Epidural Anesthesia Ropivacaine Concentration Hemodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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0.375% ropivacaine

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

Group Type ACTIVE_COMPARATOR

0.375% ropivacaine concentration

Intervention Type DRUG

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

0.75% ropivacaine

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

Group Type ACTIVE_COMPARATOR

0.75% ropivacaine concentration

Intervention Type DRUG

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

0.2% ropivacaine

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

Group Type ACTIVE_COMPARATOR

0.2% ropivacaine concentration

Intervention Type DRUG

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

Interventions

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0.75% ropivacaine concentration

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

Intervention Type DRUG

0.375% ropivacaine concentration

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

Intervention Type DRUG

0.2% ropivacaine concentration

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No