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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Information provided by:
National Taiwan University Hospital Identifier:
First received: September 7, 2009
Last updated: March 16, 2010
Last verified: March 2010
The purpose of this study is to compare if the effect of levobupivacaine on autonomic nervous system smaller than that of bupivacaine.

Condition Intervention Phase
Spinal Anesthesia
Drug: bupivacaine, levobupivacaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Comparison of the Effects of Levobupivacaine and Bupivacaine on Heart Rate Variability in Spinal Anesthesia

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • HRV values [ Time Frame: 5 minutes after drug administration ]

Estimated Enrollment: 70
Study Start Date: September 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00974961

Contact: Shih-Yu Chen, M.D. 886-5-5323911 ext 5202

Department of Anesthesiology, National Taiwan University Hospital, Yun-Lin Branch Recruiting
Yun-Lin county, Taiwan, 640
Contact: Shih-Yu Chen   
Sponsors and Collaborators
National Taiwan University Hospital
Study Chair: Shih-Yu Chen
  More Information

Responsible Party: Shihyu,Chen / Attending Stuff, Attending Stuff of Department of Anesthesiology Identifier: NCT00974961     History of Changes
Other Study ID Numbers: 200903050M
Study First Received: September 7, 2009
Last Updated: March 16, 2010

Keywords provided by National Taiwan University Hospital:
Spinal Anesthesia
Responses of ANS to these two drugs

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents processed this record on May 25, 2017