Levobupivacaine on Heart Rate Variability (HRV) in Spinal Anesthesia

Spinal Anesthesia Clinical Trial

— HRV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00974961
• Other study ID #: 200903050M
• Status: Recruiting
• Phase: Phase 4
• First received: September 7, 2009
• Last updated: March 16, 2010
• Start date: September 2009
• Est. completion date: July 2010

Study information

• Verified date: March 2010
• Source: National Taiwan University Hospital
• Contact: Shih-Yu Chen, M.D.
• Phone: 886-5-5323911
• Email: hitantc[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Anesthesia

Intervention

Drug:
• bupivacaine, levobupivacaine
intrathecal injection 15~20mg(for Levobupivacaine) or 10~15mg(for Bupivacaine) once

Locations

Country	Name	City	State
Taiwan	Department of Anesthesiology, National Taiwan University Hospital, Yun-Lin Branch	Yun-Lin county

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HRV values		5 minutes after drug administration	Yes