AnesthesiaNCT01377259
The Changes of Tissue Oxygen Saturation Under Spinal Anesthesia
An observational study of Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- tissue oxygen saturation, spinal anesthesia
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2008to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who receive operations under spinal anesthesia
Who may be able to join
- patients who receive operations under spinal anesthesia
Who cannot join
- neurological, cardiovascular diseases
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taipei, 100
ya-jung cheng, 886-2-23123456 ext. 62158, chengyj@ntu.edu.tw
About this study
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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- tissue oxygen saturation, spinal anesthesia
- Keywords
- changes, tissue, oxygenation, saturation, between, upper, lower, extremities, patients, Adverse Effect, Spinal and Epidural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue oxygen saturation, spinal anesthesiaOther
Also called NIRS model - INVOS(Somanetics) 5100B Cerebral Oximetry
regional tissue oxygen saturation(rSO2)detected over upper and lower extremities before and after spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: tissue oxygen saturation, spinal anesthesia |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startSep 2008
- Primary completionDec 2009
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- ya-jung cheng, Principal investigator, department of anesthesiology, national taiwan university nospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377259
- Sponsor's protocol ID
- 200808010R
- Status last verified
- May 2011
- First submitted
- 14 Sep 2008
- Last updated
- 21 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Changes of Tissue Oxygen Saturation Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT01377259
- Acronym / sponsor ID
- 200808010R
- Conditions
- Anesthesia
- Keywords
- changes, tissue, oxygenation, saturation, between, upper, lower, extremities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2011 (estimated)
- First posted
- 21 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1Tissue oxygenation change | – | Other: tissue oxygen saturation, spinal anesthesiaSpinal 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 |
| 2Tissue oxygenation change | – | Other: tissue oxygen saturation, spinal anesthesiaThe changes of tissue oxygenation saturation between upper and lower extremities in patients under spinal anesthesia for cesarean section |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who receive operations under spinal anesthesia
Key inclusion criteria (1 listed)
- patients who receive operations under spinal anesthesia
Key exclusion criteria (1 listed)
- neurological, cardiovascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tissue oxygen saturation, spinal anesthesiaAlso: NIRS model - INVOS(Somanetics) 5100B Cerebral Oximetryregional tissue oxygen saturation(rSO2)detected over upper and lower extremities before and after spinal anesthesia | Other | 1Tissue oxygenation change, 2Tissue oxygenation change |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2011.
Related trials for Anesthesia
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia
RecruitingObservational study
Prevalence of Pain During Cesarean Section
Cesarean Birth
RecruitingObservational study
Pulse Wave Transit Time After Infraclavicular Block
Infraclavicular Brachial Plexus Block
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Recruiting
Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ya-jung cheng principal investigator
department of anesthesiology, national taiwan university nospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya-jung Cheng, MD.,PhD. (886-2-23123456 ext. 62158, chengyj@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2011.