The Changes of Tissue Oxygen Saturation Under Spinal Anesthesia

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2011 by National Taiwan University Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT01377259

First received: September 14, 2008

Last updated: June 20, 2011

Last verified: May 2011

History of Changes

Purpose

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.

Condition	Intervention
Anesthesia	Other: tissue oxygen saturation, spinal anesthesia

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	The Changes of Tissue Oxygen Saturation Under Spinal Anesthesia

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment:	100
Study Start Date:	September 2008
Estimated Study Completion Date:	June 2011
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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 Name: 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 Name: NIRS model - INVOS(Somanetics) 5100B Cerebral Oximetry

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.

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients who receive operations under spinal anesthesia

Criteria

Inclusion Criteria:

patients who receive operations under spinal anesthesia

Exclusion Criteria:

neurological, cardiovascular diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377259

Contacts

Contact: Ya-jung Cheng, MD.,PhD.

886-2-23123456 ext 62158

chengyj@ntu.edu.tw

Locations

Taiwan
National Taiwan University Hospital	Recruiting
Taipei, Taiwan, 100
Contact: ya-jung cheng 886-2-23123456 ext 62158 chengyj@ntu.edu.tw

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator:

ya-jung cheng

department of anesthesiology, national taiwan university nospital

More Information

No publications provided

Responsible Party:	Cheng ya-jung, Department of Anesthesiology, National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT01377259 History of Changes
Other Study ID Numbers:	200808010R
Study First Received:	September 14, 2008
Last Updated:	June 20, 2011
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

changes
tissue
oxygenation
saturation
between
upper

lower
extremities
patients
Adverse Effect
Spinal and Epidural

Additional relevant MeSH terms:

Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013

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