HealthyNCT03060798
The Change of Tissue Oxygen Saturation Following Volatile Anesthesia
An observational study of Healthy and Aging, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
General anesthesia can affect tissue oxygen saturation and microcirculatory reactivity. However, the differences in microcirculation caused by anesthetic methods have not been well studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Desflurane and Near-infrared spectroscopy monitor
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult male and female patients over 18 years of age undergoing general surgery under general anesthesia. American anesthesiologists association patient (ASA) category I or II.
Who may be able to join
- Adult Over 18 years of age undergoing general surgery under general anesthesia.
Who cannot join
- ASA category III or IV, Diabetes, Chronic Kidney Disease, Vascular Disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Change of Tissue Oxygen Saturation Measured by Dynamic Near Infrared Spectroscopy Following Volatile Anesthesia in Healthy Population
General anesthesia can affect tissue oxygen saturation and microcirculatory reactivity. However, the differences in microcirculation caused by anesthetic methods have not been well studied. Near-infrared spectroscopy (NIRS) measures peripheral tissue oxygen saturation noninvasively and can be used in conjunction with vascular occlusion (VOT) experiments. The purpose of this study was to examine the changes in NIRS derived tissue oxygen saturation (StO2) and microcirculatory reactivity by VOT after inhalation anesthesia in healthy population.
This prospective, observational study will be performed on 60 healthy patients who had undergone elective surgery under volatile general anesthesia. The investigators measure StO2 and microvascular reactivity using NIRS combined with vascular occlusion test (VOT). The parameters were performed twice per patient, before and after the induction of anesthesia.
Occlusion slope and recovery slope during VOT will be compared before and after anesthesia. Moreover, the changes depend on the age will be analyzed.
Read the detailed description
This prospective observational study was performed on 60 patients without comorbidities who underwent elective surgery under general anesthesia. Before and after the induction of anesthesia, StO2 monitoring and VOT were performed to investigate the effect of anesthesia on microcirculation. To investigate the effect of age on microcirculation, the patients were divided into two different groups, young (< 65 yrs) and old (> 65 yrs) groups, and the VOT-derived parameters and hemodynamics between two groups were compared.
- Being tested
- Desflurane, Near-infrared spectroscopy monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Also called suprane
general anesthesia using desflurane.
Near-infrared spectroscopy monitorDevice
Also called tissue oxygen saturation monitor
tissue oxygen saturation monitoring combined with vessel occlusion test
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Tissue Oxygen Saturation after General Anesthesia
Vascular occlusion test (VOT) will be performed twice for each patient, before (T0) and 30 min after the induction of general anesthesia (T1). Before induction, a NIRS sensor will be placed on the thenar eminence and an automated tourniquet will be placed around the ipsilateral upper arm. After the baseline StO2 stabilization, the automatic tourniquet will be inflated to 50 mmHg over the patient's baseline systolic blood pressure and maintain for 5 min. After the 5-min ischemic period, the tourniquet will be rapidly deflated to 0 mmHg. StO2 data will be continuously recorded during the VOT procedure. Baseline StO2, minimum StO2 during the 5-min inflation of the tourniquet, maximum StO2 during deflation of the tourniquet, time to minimum StO2, and time to maximum StO2 will be obtained. The occlusion slope and recovery slope will be calculated based on the measured StO2 data.
Measured: before and 30 minutes after anesthetic induction
Secondary outcomes (1)
Age-related changes in microcirculation
Patients will be divided into three groups by age (younger group: < 65 years old and older group: ≥ 65 years old) to perform age-based analysis. The acquired StO2 data by the VOT test among the groups will be analyzed and compared.
Measured: before and 30 minutes after anesthetic induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start2 Aug 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 HealthyStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeon-Jeong Lee, Pusan National University Hospital
- Investigators
- Hyeon-Jeong Lee, PhD, Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060798
- Sponsor's protocol ID
- 1607-012-054
- Status last verified
- Apr 2020
- First submitted
- 19 Feb 2017
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Change of Tissue Oxygen Saturation Measured by Dynamic Near Infrared Spectroscopy Following Volatile Anesthesia in Healthy Population
- ClinicalTrials.gov ID
- NCT03060798
- Acronym / sponsor ID
- 1607-012-054
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 2 Aug 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 23 Feb 2017 (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.
General anesthesia can affect tissue oxygen saturation and microcirculatory reactivity. However, the differences in microcirculation caused by anesthetic methods have not been well studied. Near-infrared spectroscopy (NIRS) measures peripheral tissue oxygen saturation noninvasively and can be used in conjunction with vascular occlusion (VOT) experiments. The purpose of this study was to examine the changes in NIRS derived tissue oxygen saturation (StO2) and microcirculatory reactivity by VOT after inhalation anesthesia in healthy population.
This prospective, observational study will be performed on 60 healthy patients who had undergone elective surgery under volatile general anesthesia. The investigators measure StO2 and microvascular reactivity using NIRS combined with vascular occlusion test (VOT). The parameters were performed twice per patient, before and after the induction of anesthesia.
Occlusion slope and recovery slope during VOT will be compared before and after anesthesia. Moreover, the changes depend on the age will be analyzed.
Detailed description
This prospective observational study was performed on 60 patients without comorbidities who underwent elective surgery under general anesthesia. Before and after the induction of anesthesia, StO2 monitoring and VOT were performed to investigate the effect of anesthesia on microcirculation. To investigate the effect of age on microcirculation, the patients were divided into two different groups, young (< 65 yrs) and old (> 65 yrs) groups, and the VOT-derived parameters and hemodynamics between two groups were compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male and female patients over 18 years of age undergoing general surgery under general anesthesia. American anesthesiologists association patient (ASA) category I or II.
Key inclusion criteria (1 listed)
- Adult Over 18 years of age undergoing general surgery under general anesthesia.
Key exclusion criteria (1 listed)
- ASA category III or IV, Diabetes, Chronic Kidney Disease, Vascular Disease
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 |
|---|---|---|
| DesfluraneAlso: supranegeneral anesthesia using desflurane. | Drug | – |
| Near-infrared spectroscopy monitorAlso: tissue oxygen saturation monitortissue oxygen saturation monitoring combined with vessel occlusion test | Device | – |
Primary outcome
Changes in Tissue Oxygen Saturation after General Anesthesia
Time frame: before and 30 minutes after anesthetic induction
Vascular occlusion test (VOT) will be performed twice for each patient, before (T0) and 30 min after the induction of general anesthesia (T1). Before induction, a NIRS sensor will be placed on the thenar eminence and an automated tourniquet will be placed around the ipsilateral upper arm. After the baseline StO2 stabilization, the automatic tourniquet will be inflated to 50 mmHg over the patient's baseline systolic blood pressure and maintain for 5 min. After the 5-min ischemic period, the tourniquet will be rapidly deflated to 0 mmHg. StO2 data will be continuously recorded during the VOT procedure. Baseline StO2, minimum StO2 during the 5-min inflation of the tourniquet, maximum StO2 during deflation of the tourniquet, time to minimum StO2, and time to maximum StO2 will be obtained. The occlusion slope and recovery slope will be calculated based on the measured StO2 data.
1 secondary outcome
Age-related changes in microcirculation
Time frame: before and 30 minutes after anesthetic induction
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 14 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Hyeon-Jeong Lee, 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 Healthy and Aging, 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 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: finished, as of the sponsor's last update on 14 Apr 2020. 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?
Changes in Tissue Oxygen Saturation after General Anesthesia (time frame: before and 30 minutes after anesthetic induction). 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 14 Apr 2020.