Levobupivacaine on Heart Rate Variability (HRV) in Spinal Anesthesia

Phase 4

• Conditions: Spinal Anesthesia
• Interventions: Drug: bupivacaine, levobupivacaine

• Registration Number: NCT00974961
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-07
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Primary Completion: 2009-12
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-16
• Last Update Posted: 2010-03-18
• Study Completion: 2010-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Indicated for spinal anesthesia

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Exclusion Criteria

• Allergic reaction to local anesthetics
• Coagulopathy
• Severe spinal deformity
• Cardiac diseases
• Metabolic diseases (such as DM, thyroid or adrenal diseases)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levobupivacaine	bupivacaine, levobupivacaine	Lumbar puncture with Levobupivacaine for spinal anesthesia
Bupivacaine	bupivacaine, levobupivacaine	Lumbar puncture with Bupivacaine for spinal anesthesia

Primary Outcome Measures

Name	Time	Method
HRV values	5 minutes after drug administration

Trial Locations

Locations (1)

Department of Anesthesiology, National Taiwan University Hospital, Yun-Lin Branch; 🇨🇳 Yun-Lin county, Taiwan