Levobupivacaine on Heart Rate Variability (HRV) in Spinal Anesthesia (HRV)

March 16, 2010 updated by: National Taiwan University Hospital

Comparison of the Effects of Levobupivacaine and Bupivacaine on Heart Rate Variability in Spinal Anesthesia

The purpose of this study is to compare if the effect of levobupivacaine on autonomic nervous system smaller than that of bupivacaine.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Obtain the heart rate variability (in means and standard deviation, including the high frequency, low frequency and its ratio) data of before and after spinal anesthesia with ECG (and Heart Rate Variability Analyzer) in 2 groups. Meanwhile, record the blood pressure on each subject.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Yun-Lin county, Taiwan, 640
        • Recruiting
        • Department of Anesthesiology, National Taiwan University Hospital, Yun-Lin Branch
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Indicated for spinal anesthesia

Exclusion Criteria:

  • Allergic reaction to local anesthetics
  • Coagulopathy
  • Severe spinal deformity
  • Cardiac diseases
  • Metabolic diseases (such as DM, thyroid or adrenal diseases)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Levobupivacaine
Lumbar puncture with Levobupivacaine for spinal anesthesia
Drug: bupivacaine, levobupivacaine
intrathecal injection 15~20mg(for Levobupivacaine) or 10~15mg(for Bupivacaine) once
ACTIVE_COMPARATOR: Bupivacaine
Lumbar puncture with Bupivacaine for spinal anesthesia
Drug: bupivacaine, levobupivacaine
intrathecal injection 15~20mg(for Levobupivacaine) or 10~15mg(for Bupivacaine) once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HRV values
Time Frame: 5 minutes after drug administration
5 minutes after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Chair: Shih-Yu Chen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2009

Study Completion (ANTICIPATED)

July 1, 2010

Study Registration Dates

First Submitted

September 7, 2009

First Submitted That Met QC Criteria

September 10, 2009

First Posted (ESTIMATE)

September 11, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2010

Last Update Submitted That Met QC Criteria

March 16, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200903050M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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