The Changes of Tissue Oxygen Saturation Under Spinal Anesthesia

June 20, 2011 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In patients who were planned to receive an operation with intrathecal anesthesia, NIRS (INVOS Cerebral Oximeter Model 5100B; Somanetics, Troy, MI, USA) with two adhesive patches was used to monitor rSO2. One patch was applied over the biceps brachii muscle,(the body part above the anaesthetic level), and the other patch was applied over the medial side of the gastrocnemius muscle of the non-surgical leg,(the body part below the anaesthetic level). In both extremities, rSO2 was monitored continuously and recorded every minute from before intrathecal bupivacaine injection until 15 min after injection. Isobaric bupivacaine 0.5% 10-15 mg was injected intrathecally and the level of anaesthesia was examined 10 min later by loss of cold sensation to alcohol swab by an anaesthetist not involved in the study. the changes of rSO2 of upper and lower extrimities were recorded and analysed.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who receive operations under spinal anesthesia

Description

Inclusion Criteria:

  • patients who receive operations under spinal anesthesia

Exclusion Criteria:

  • neurological, cardiovascular diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
regional tissue oxygen saturation(rSO2)detected over upper and lower extremities before and after spinal anesthesia
Other Names:
  • NIRS model - INVOS(Somanetics) 5100B Cerebral Oximetry
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
regional tissue oxygen saturation(rSO2)detected over upper and lower extremities before and after spinal anesthesia
Other Names:
  • NIRS model - INVOS(Somanetics) 5100B Cerebral Oximetry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: ya-jung cheng, department of anesthesiology, national taiwan university nospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

September 14, 2008

First Submitted That Met QC Criteria

June 20, 2011

First Posted (Estimate)

June 21, 2011

Study Record Updates

Last Update Posted (Estimate)

June 21, 2011

Last Update Submitted That Met QC Criteria

June 20, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200808010R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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