Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on March 03, 2015