NCT00974961

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

March 18, 2010

Status Verified

March 1, 2010

Enrollment Period

3 months

First QC Date

September 7, 2009

Last Update Submit

March 16, 2010

Conditions

Spinal Anesthesia

Keywords

LevobupivacaineHRVSpinal AnesthesiaResponses of ANS to these two drugs

Outcome Measures

Primary Outcomes (1)

  • HRV values

    5 minutes after drug administration

Study Arms (2)

Levobupivacaine

ACTIVE COMPARATOR

Lumbar puncture with Levobupivacaine for spinal anesthesia

Drug: bupivacaine, levobupivacaine

Bupivacaine

ACTIVE COMPARATOR

Lumbar puncture with Bupivacaine for spinal anesthesia

Drug: bupivacaine, levobupivacaine

Interventions

bupivacaine, levobupivacaineDRUG

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

BupivacaineLevobupivacaine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Indicated for spinal anesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, National Taiwan University Hospital, Yun-Lin Branch

Yun-Lin County, 640, Taiwan

RECRUITING

MeSH Terms

Interventions

BupivacaineLevobupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Shih-Yu Chen

    STUDY CHAIR

Central Study Contacts

Shih-Yu Chen, M.D.

CONTACT

886-5-5323911hitantc@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2009

First Posted

September 11, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2009

Study Completion

July 1, 2010

Last Updated

March 18, 2010

Record last verified: 2010-03

Locations

TW(1)