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

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.

Study Overview

• Status: Completed
• Conditions: Hemodynamics; Epidural Anesthesia; Ropivacaine Concentration
• Intervention / Treatment: Drug: 0.375% ropivacaine concentration; Drug: 0.75% ropivacaine concentration; Drug: 0.2% ropivacaine concentration

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yangsan, Korea, Republic of, 626770
    • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 0.375% ropivacaine; 0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia	Drug: 0.375% ropivacaine concentration; 0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia
Active Comparator: 0.75% ropivacaine; 0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia	Drug: 0.75% ropivacaine concentration; 0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia
Active Comparator: 0.2% ropivacaine; 0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia	Drug: 0.2% ropivacaine concentration; 0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pusan National University Hospital
• Investigators: Principal Investigator: Hyeon Jeong Lee, PhD, MD, Dept. of Anesthesia, Pusan National University, School of Medicine

Publications and helpful links

General Publications

• Hong JM, Lee HJ, Oh YJ, Cho AR, Kim HJ, Lee DW, Do WS, Kwon JY, Kim H. Observations on significant hemodynamic changes caused by a high concentration of epidurally administered ropivacaine: correlation and prediction study of stroke volume variation and central venous pressure in thoracic epidural anesthesia. BMC Anesthesiol. 2017 Nov 16;17(1):153. doi: 10.1186/s12871-017-0444-x.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2011
• Primary Completion (Actual): April 19, 2013
• Study Completion (Actual): April 19, 2013

Study Registration Dates

• First Submitted: March 19, 2012
• First Submitted That Met QC Criteria: March 20, 2012
• First Posted (Estimate): March 21, 2012

Study Record Updates

• Last Update Posted (Actual): August 29, 2017
• Last Update Submitted That Met QC Criteria: August 28, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: epidural, local, ropivacaine; epidural administration; stroke volume variability
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: PNU05-2011-054