PNU: Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters

• Sponsor: Pusan National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01559285
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Actual Duration (Months): 17.1
• Patients Per Site Per Month: 7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epidural Anesthesia; Ropivacaine Concentration; Hemodynamics	Drug: 0.75% ropivacaine concentration; Drug: 0.375% ropivacaine concentration; Drug: 0.2% ropivacaine concentration	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effects of Epidurally Administered Ropivacaine Concentration on the Hemodynamic Parameters
• Actual Study Start Date: Nov 16, 2011
• Actual Primary Completion Date: Apr 19, 2013
• Actual Study Completion Date: Apr 19, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pusan National University Yangsan Hospital	Yangsan		Korea, Republic of	626770

Sponsors and Collaborators

• Pusan National University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hyeon-Jeong Lee, Assisstant Professor, Pusan National University Hospital
• ClinicalTrials.gov Identifier: NCT01559285
• Other Study ID Numbers: PNU05-2011-054
• First Posted: Mar 21, 2012
• Last Update Posted: Aug 29, 2017
• Last Verified: Aug 1, 2017

• Keywords provided by Hyeon-Jeong Lee, Assisstant Professor, Pusan National University Hospital: epidural, local, ropivacaine; epidural administration; stroke volume variability
• Additional relevant MeSH terms: Ropivacaine

Study Results

No Results Posted as of Aug 29, 2017