Spinal AnesthesiaNCT04806997
Changes in the Microvascular Reactivity on Leg During Spinal Anesthesia
An observational study of Spinal Anesthesia, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
Anesthesia alters microcirculation and tissue oxygen saturation (StO2). We sought to examine changes in StO2 using near-infrared spectroscopy and a vascular occlusion test (VOT) during spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- Vascular occlusion test
- Type of treatment
- Injection or infusion
- How many people
- 51 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Dec 2016to 31 Dec 2017
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: adult patients, 18<age< 60 years old, scheduled for spinal anesthesia
Who may be able to join
- The patients who were scheduled for spinal anesthesia
- 18< age < 60 years old
Who cannot join
- American Society of Anesthesiologists physical status class > III,
- allergy or sensitivity to study medications,
- alcohol or drug abuse history,
- body mass index > 35 kg/ m2 or < 15 kg/m2,
- p regnancy or breastfeeding status,
- diabetes and on insulin treatment,
Show all 10Show fewer
- untreated or uncontrolled arterial hypertension,
- peripheral arterial disease,
- corticosteroid treatment, coagulopathy, and lower limb deformities or burns
- patients who may not tolerate VOT
Trial locations and contacts
1 site in 1 country.
About this study
Anesthesia alters microcirculation and tissue oxygen saturation (StO2). We sought to examine changes in StO2 using near-infrared spectroscopy and a vascular occlusion test (VOT) during spinal anesthesia. This prospective observational study was included 51 patients without comorbidities who underwent elective surgery under spinal anesthesia. We measured the StO2 in the lower extremity during VOT before and after intrathecal injection.
Read the detailed description
The vascular occlusion test (VOT) procedure was conducted twice in each patient, before and 15 min after intrathecal injection. An near-infrared spectroscopy (NIRS) sensor (INVOSTM 5100C Cerebral/Somatic Oximeter; Medtronic, Minneapolis, MN, USA) was attached to the patient's gastrocnemius muscle. A tourniquet (A.T.S ® 3000 Automatic Tourniquet System; Zimmer Inc., Warsaw, IL, USA) was applied to the thigh and inflated to a pressure value 50 mmHg over the patient's baseline systolic blood pressure in the leg and maintained for 5 min. After a 5-min ischemic period, the tourniquet was rapidly deflated to 0 mmHg. The tissue oxygen saturation (StO2) data was continuously recorded during the VOT procedure. After confirmation of spinal anesthesia using cold sensitivity, the VOT procedure was repeated in the same manner as mentioned above. The occlusion slope and recovery slope were calculated based on the measured StO2 data. The occlusion slope was defined as the descending slope of StO2 value until it reached the minimum value. The recovery slope was calculated from the deflation of the tourniquet until the recovery of StO2 to the maximum value.
- Conditions
- Spinal Anesthesia
- Being tested
- Vascular occlusion test
- Keywords
- Microvascular Circulation, Spectroscopy, near-infrared, Spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular occlusion testDiagnostic test
The VOT procedure was conducted twice in each patient, before and 15 min after intrathecal injection. An NIRS sensor (INVOSTM 5100C Cerebral/Somatic Oximeter; Medtronic, Minneapolis, MN, USA) was attached to the patient's gastrocnemius muscle. A tourniquet (A.T.S ® 3000 Automatic Tourniquet System; Zimmer Inc., Warsaw, IL, USA) was applied to the thigh and inflated to a pressure value 50 mmHg over the patient's baseline systolic blood pressure in the leg and maintained for 5 min. After a 5-min ischemic period, the tourniquet was rapidly deflated to 0 mmHg. The StO2 data was continuously recorded during the VOT procedure. After confirmation of spinal anesthesia using cold sensitivity, the VOT procedure was repeated in the same manner as mentioned above. The occlusion slope and recovery slope were calculated based on the measured StO2 data.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of recovery slope between baseline and after spinal anesthesia
Recovery slope is related to microvascular reactivity, was calculated from the deflation of the tourniquet until the recovery of tissue oxygen saturation to the highest value
Measured: baseline and immediately after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start29 Dec 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyae-Jin Kim, Pusan National University Hospital
- Investigators
- Hyae-Jin Kim, PhD, Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806997
- Sponsor's protocol ID
- No. H-1611-016-048
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Microvascular Reactivity on Leg During Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT04806997
- Acronym / sponsor ID
- No. H-1611-016-048
- Conditions
- Spinal Anesthesia
- Keywords
- Microvascular Circulation, Spectroscopy, near-infrared, Spinal anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 29 Dec 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 19 Mar 2021 (actual)
- 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.
Anesthesia alters microcirculation and tissue oxygen saturation (StO2). We sought to examine changes in StO2 using near-infrared spectroscopy and a vascular occlusion test (VOT) during spinal anesthesia. This prospective observational study was included 51 patients without comorbidities who underwent elective surgery under spinal anesthesia. We measured the StO2 in the lower extremity during VOT before and after intrathecal injection.
Detailed description
The vascular occlusion test (VOT) procedure was conducted twice in each patient, before and 15 min after intrathecal injection. An near-infrared spectroscopy (NIRS) sensor (INVOSTM 5100C Cerebral/Somatic Oximeter; Medtronic, Minneapolis, MN, USA) was attached to the patient's gastrocnemius muscle. A tourniquet (A.T.S ® 3000 Automatic Tourniquet System; Zimmer Inc., Warsaw, IL, USA) was applied to the thigh and inflated to a pressure value 50 mmHg over the patient's baseline systolic blood pressure in the leg and maintained for 5 min. After a 5-min ischemic period, the tourniquet was rapidly deflated to 0 mmHg. The tissue oxygen saturation (StO2) data was continuously recorded during the VOT procedure. After confirmation of spinal anesthesia using cold sensitivity, the VOT procedure was repeated in the same manner as mentioned above. The occlusion slope and recovery slope were calculated based on the measured StO2 data. The occlusion slope was defined as the descending slope of StO2 value until it reached the minimum value. The recovery slope was calculated from the deflation of the tourniquet until the recovery of StO2 to the maximum value.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- adult patients, 18<age< 60 years old, scheduled for spinal anesthesia
Key inclusion criteria (2 listed)
- The patients who were scheduled for spinal anesthesia
- 18< age < 60 years old
Key exclusion criteria (10 listed)
- American Society of Anesthesiologists physical status class > III,
- allergy or sensitivity to study medications,
- alcohol or drug abuse history,
- body mass index > 35 kg/ m2 or < 15 kg/m2,
- p regnancy or breastfeeding status,
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 |
|---|---|---|
| Vascular occlusion testThe VOT procedure was conducted twice in each patient, before and 15 min after intrathecal injection. An NIRS sensor (INVOSTM 5100C Cerebral/Somatic Oximeter; Medtronic, Minneapolis, MN, USA) was attached to the patient's gastrocnemius muscle. A tourniquet (A.T.S ® 3000 Automatic Tourniquet System; Zimmer Inc., Warsaw, IL, USA) was applied to the thigh and inflated to a pressure value 50 mmHg over the patient's baseline systolic blood pressure in the leg and maintained for 5 min. After a 5-min ischemic period, the tourniquet was rapidly deflated to 0 mmHg. The StO2 data was continuously recorded during the VOT procedure. After confirmation of spinal anesthesia using cold sensitivity, the VOT procedure was repeated in the same manner as mentioned above. The occlusion slope and recovery slope were calculated based on the measured StO2 data. | Diagnostic test | – |
Primary outcome
Change of recovery slope between baseline and after spinal anesthesia
Time frame: baseline and immediately after spinal anesthesia
Recovery slope is related to microvascular reactivity, was calculated from the deflation of the tourniquet until the recovery of tissue oxygen saturation to the highest value
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
Hyae-Jin Kim, PhD principal investigator
Pusan National University Hospital
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 Spinal Anesthesia, run by Pusan National University Hospital at 1 site in South Korea.
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 2 inclusion and 10 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: finished, as of the sponsor's last update on 19 Mar 2021. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of recovery slope between baseline and after spinal anesthesia (time frame: baseline and immediately after spinal anesthesia). It is what the study was designed to measure, not a finding.
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 19 Mar 2021.