The Changes of Tissue Oxygen Saturation Under Spinal Anesthesia

Anesthesia Clinical Trial

Official title:

The Changes of Tissue Oxygen Saturation Under Spinal Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01377259
• Other study ID #: 200808010R
• Status: Recruiting
• Phase: N/A
• First received: September 14, 2008
• Last updated: June 20, 2011
• Start date: September 2008
• Est. completion date: June 2011

Study information

• Verified date: May 2011
• Source: National Taiwan University Hospital
• Contact: Ya-jung Cheng, MD.,PhD.
• Phone: 886-2-23123456
• Email: chengyj[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients who receive operations under spinal anesthesia

Exclusion Criteria:

• neurological, cardiovascular diseases

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan,