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Levobupivacaine on Heart Rate Variability (HRV) in Spinal Anesthesia

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National Taiwan University

Status and phase

Unknown
Phase 4

Conditions

Spinal Anesthesia

Treatments

Drug: bupivacaine, levobupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT00974961
200903050M

Details and patient eligibility

About

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

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

Levobupivacaine
Active Comparator group
Description:
Lumbar puncture with Levobupivacaine for spinal anesthesia
Treatment:
Drug: bupivacaine, levobupivacaine
Bupivacaine
Active Comparator group
Description:
Lumbar puncture with Bupivacaine for spinal anesthesia
Treatment:
Drug: bupivacaine, levobupivacaine

Trial contacts and locations

1

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Central trial contact

Shih-Yu Chen, M.D.

Data sourced from clinicaltrials.gov

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