We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00974961
First Posted: September 11, 2009
Last Update Posted: March 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
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 (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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974961


Contacts
Contact: Shih-Yu Chen, M.D. 886-5-5323911 ext 5202 hitantc@gmail.com

Locations
Taiwan
Department of Anesthesiology, National Taiwan University Hospital, Yun-Lin Branch Recruiting
Yun-Lin county, Taiwan, 640
Contact: Shih-Yu Chen       hitantc@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Shih-Yu Chen
  More Information

Responsible Party: Shihyu,Chen / Attending Stuff, Attending Stuff of Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT00974961     History of Changes
Other Study ID Numbers: 200903050M
First Submitted: September 7, 2009
First Posted: September 11, 2009
Last Update Posted: March 18, 2010
Last Verified: March 2010

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

Additional relevant MeSH terms:
Anesthetics
Bupivacaine
Levobupivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents