Levobupivacaine on Heart Rate Variability (HRV) in Spinal Anesthesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00974961
First received: September 7, 2009
Last updated: March 16, 2010
Last verified: March 2010

September 7, 2009
March 16, 2010
September 2009
December 2009   (final data collection date for primary outcome measure)
HRV values [ Time Frame: 5 minutes after drug administration ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00974961 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Levobupivacaine on Heart Rate Variability (HRV) in Spinal Anesthesia
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Spinal Anesthesia
Drug: bupivacaine, levobupivacaine
intrathecal injection 15~20mg(for Levobupivacaine) or 10~15mg(for Bupivacaine) once
  • Active Comparator: Levobupivacaine
    Lumbar puncture with Levobupivacaine for spinal anesthesia
    Intervention: Drug: bupivacaine, levobupivacaine
  • Active Comparator: Bupivacaine
    Lumbar puncture with Bupivacaine for spinal anesthesia
    Intervention: Drug: bupivacaine, levobupivacaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
July 2010
December 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years to 60 Years
No
Contact: Shih-Yu Chen, M.D. 886-5-5323911 ext 5202 hitantc@gmail.com
Taiwan
 
NCT00974961
200903050M
No
Shihyu,Chen / Attending Stuff, Attending Stuff of Department of Anesthesiology
National Taiwan University Hospital
Not Provided
Study Chair: Shih-Yu Chen
National Taiwan University Hospital
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP