NCT01377259

Brief Summary

Neuraxial anesthesia affords a less interventional way to desensitization of the lower body for surgical procedures. After introduction of neuraxial anesthesia, vasodilatation of body part below the anesthetic level is theoretically appeared as the sympathetic nerve efferent is blocked. The vasodilatation effect is related to hypotension, hypothermia, shivering and the response of volume redistribution. It is believed that vasodilatation leads to better regional tissue perfusion and better regional tissue oxygenation. Previous reports of laser doppler flowmetry and thermography showed their effectiveness on monitoring blocked level but they were not easily available in the operation room. Recently Near-infrared spectroscopy(NIRS) demonstrates real-time tissue oxygen saturation(rSO2) which is applied generally in non-invasive brain oximeter. We use NIRS in spinal anesthesia to monitor the tissue oxygenation change over the upper and lower limbs during the induction of neuraxial anesthesia.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2008

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 21, 2011

Completed
Last Updated

June 21, 2011

Status Verified

May 1, 2011

Enrollment Period

1.2 years

First QC Date

September 14, 2008

Last Update Submit

June 20, 2011

Conditions

Keywords

changestissueoxygenationsaturationbetweenupperlowerextremitiespatientsAdverse EffectSpinal and Epidural

Study Arms (2)

1Tissue oxygenation change

Spinal anesthesia may result different changes of tissue oxygenation in blocked area ( upper extrimities ) and non-blocked area ( lower extrimities). The changes of tissue oxygenation saturation between upper and lower extremities in patients under spinal anesthesia for orthopedic surgery

Other: tissue oxygen saturation, spinal anesthesia

2Tissue oxygenation change

The changes of tissue oxygenation saturation between upper and lower extremities in patients under spinal anesthesia for cesarean section

Other: tissue oxygen saturation, spinal anesthesia

Interventions

regional tissue oxygen saturation(rSO2)detected over upper and lower extremities before and after spinal anesthesia

Also known as: NIRS model - INVOS(Somanetics) 5100B Cerebral Oximetry
1Tissue oxygenation change2Tissue oxygenation change

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who receive operations under spinal anesthesia

You may qualify if:

  • patients who receive operations under spinal anesthesia

You may not qualify if:

  • neurological, cardiovascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • ya-jung cheng

    department of anesthesiology, national taiwan university nospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ya-jung Cheng, MD.,PhD.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2008

First Posted

June 21, 2011

Study Start

September 1, 2008

Primary Completion

December 1, 2009

Study Completion

June 1, 2011

Last Updated

June 21, 2011

Record last verified: 2011-05

Locations