Levobupivacaine on Heart Rate Variability (HRV) in Spinal Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Spinal Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Levobupivacaine

Lumbar puncture with Levobupivacaine for spinal anesthesia

Group Type ACTIVE_COMPARATOR

bupivacaine, levobupivacaine

Intervention Type DRUG

intrathecal injection 15\~20mg(for Levobupivacaine) or 10\~15mg(for Bupivacaine) once

Bupivacaine

Lumbar puncture with Bupivacaine for spinal anesthesia

Group Type ACTIVE_COMPARATOR

bupivacaine, levobupivacaine

Intervention Type DRUG

intrathecal injection 15\~20mg(for Levobupivacaine) or 10\~15mg(for Bupivacaine) once

Interventions

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bupivacaine, levobupivacaine

intrathecal injection 15\~20mg(for Levobupivacaine) or 10\~15mg(for Bupivacaine) once

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No