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

Status

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Unknown

Conditions

Conditions

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Intervention / Treatment

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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

Study Type

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Observational

Enrollment (Anticipated)

Enrollment

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100

Contacts and Locations

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Study Contact

Study Contact

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  • Name: Ya-jung Cheng, MD.,PhD.
  • Phone Number: 62158 886-2-23123456
  • Email: chengyj@ntu.edu.tw

Study Locations

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

Participation Criteria

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Eligibility Criteria

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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

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How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

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Sponsor

Sponsor

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National Taiwan University Hospital

Investigators

Investigators

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

Study record dates

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Study Major Dates

Study Start

Study Start

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September 1, 2008

Primary Completion (Actual)

Primary Completion

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December 1, 2009

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 200808010R

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