Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters (PNU)

Pusan National University

Status and phase: Completed; Phase 4

Conditions: Epidural Anesthesia; Ropivacaine Concentration; Hemodynamics

Treatments: Drug: 0.2% ropivacaine concentration; Drug: 0.75% ropivacaine concentration; Drug: 0.375% ropivacaine concentration

Study type: Interventional

Funder types: Other

Identifiers

NCT01559285

PNU05-2011-054

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

0.375% ropivacaine

Active Comparator group

Description:

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

Treatment:

Drug: 0.375% ropivacaine concentration

0.75% ropivacaine

Active Comparator group

Description:

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

Treatment:

Drug: 0.75% ropivacaine concentration

0.2% ropivacaine

Active Comparator group

Description:

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

Treatment:

Drug: 0.2% ropivacaine concentration