Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters

Hemodynamics Clinical Trial

— PNU  

Official title:

Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559285
• Other study ID #: PNU05-2011-054
• Status: Completed
• Phase: Phase 4
• First received: March 19, 2012
• Last updated: August 28, 2017
• Start date: November 16, 2011
• Est. completion date: April 19, 2013

Study information

• Verified date: August 2017
• Source: Pusan National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 19, 2013
• Est. primary completion date: April 19, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Epidural Anesthesia
• Hemodynamics
• Ropivacaine Concentration

Intervention

Drug:
• 0.75% ropivacaine concentration
0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia
• 0.375% ropivacaine concentration
0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia
• 0.2% ropivacaine concentration
0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	during 1hour after administration of epidural drug dosing