ObesityNCT05829785
Influence of Obesity on Microvascular Reactivity During General Anesthesia
An observational study of Obesity and Anesthesia, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study was to investigate the effect of obesity on changes in microvascular reactivity and tissue oxygen saturation (StO2) during general anesthesia using near-infrared spectroscopy in conjunction with vascular occlusion tests (VOT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Anesthesia, Microcirculation
- What is being tested?
- Near-infrared spectroscopy monitor
- Type of treatment
- Medical device
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2018to 28 Feb 2021
- 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: Subjects who underwent elective surgery under general anesthesia between 2018 and 2021 in Pusan national univ. hospital.
Who may be able to join
- Subjects who underwent elective surgery under general anesthesia.
Who cannot join
- Society of Anesthesiologists (ASA) physical status > II
- patients with a neuraxial block
- uncontrolled hypertension
- patients with major cardiovascular disease
- diabetes
- pregnant individuals
Show all 10Show fewer
- peripheral vascular disease
- chronic venous insufficiency
- smoking: Pack-years > 10
- chronic obstructive and restrictive pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to investigate the effect of obesity on changes in microvascular reactivity and tissue oxygen saturation (StO2) during general anesthesia using near-infrared spectroscopy in conjunction with vascular occlusion tests (VOT).
For this prospective observation investigation, a total of 128 patients who underwent elective surgery under general anesthesia at Pusan National University Hospital between June 2018 and February 2021 were participated in this study. Baseline StO2 on thenar eminence, hemodynamics, and laboratory profile were monitored before (Tpre) and 30 min after general anesthesia (Tpost). During vascular occlusion tests (VOT), the occlusion slope representing oxygen consumption of muscle and recovery slope representing microvascular reactivity were also collected at Tpre and Tpost. For analysis, the patients were divided into two groups: overweight (body mass index [BMI] ≥ 25 kg/m2) and normal weight (BMI < 25).
Read the detailed description
Preoperative laboratory findings were obtained. Mean blood pressure (MBP), pulse oxygen saturation (SpO2), heart rate (HR), skin temperature, and VOT-derived measurements, including baseline tissue oxygen saturation (StO2), occlusion slope, minimum StO2, time to minimum StO2, recovery slope, maximum StO2, and time to baseline StO2 were recorded before (Tpre) and 30 min after general anesthesia (Tpost).
- Conditions
- Obesity, Anesthesia, Microcirculation
- Being tested
- Near-infrared spectroscopy monitor
- Keywords
- Obesity, Body mass index, Anesthesia, general, Microcirculation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared spectroscopy monitorDevice
tissue oxygen saturation monitoring combined with vascular occlusion test
| Study group | Role | What they receive |
|---|---|---|
| overweight group | Subjects with a body mass index (BMI) ≥ 25 Receives: Device: Near-infrared spectroscopy monitor | |
| normal weight group | Subjects with BMI < 25 Receives: Device: Near-infrared spectroscopy monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery slope after general aneshtesia (Tpost)
Representing microvascular reactivity (Tpost: 30 minutes after general anesthesia); recovery slope was calculated from deflation of the tourniquet until the recovery of StO2 to the baseline value.
Measured: 10 minutes
Secondary outcomes (3)
Recovery slope before general aneshtesia (Tpre)
Representing microvascular reactivity (Tpre: before general anesthesia); recovery slope was calculated from deflation of the tourniquet until the recovery of StO2 to the baseline value.
Measured: 10 minutes
Occlusion slope before general anesthesia (Tpre)
representing oxygen consumption of muscle (Tpre: before general anesthesia); occlusion slope was defined as the slope of StO2 descent to the lowest value.
Measured: 10 minutes
Occlusion slope before general anesthesia (Tpost)
representing oxygen consumption of muscle (Tpost: 30 minutes after general anesthesia); occlusion slope was defined as the slope of StO2 descent to the lowest value.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 Jun 2018
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- 128 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829785
- Sponsor's protocol ID
- 2018-0175
- Other IDs
- 1804-025-066
- Status last verified
- Oct 2023
- First submitted
- 13 Apr 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cho AR, Lee HJ, Kim HJ, Do W, Jeon S, Baek SH, Kim ES, Kwon JY, Kim HK. Microvascular Reactivity Measured by Dynamic Near-infrared Spectroscopy Following Induction of General Anesthesia in Healthy Patients: Observation of Age-related Change. Int J Med Sci. 2021 Jan 1;18(5):1096-1103. doi: 10.7150/ijms.52433. eCollection 2021.
PubMed 33526968
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Obesity on Microvascular Reactivity During General Anesthesia
- ClinicalTrials.gov ID
- NCT05829785
- Acronym / sponsor ID
- 2018-0175
- Conditions
- Obesity, Anesthesia, Microcirculation
- Keywords
- Obesity, Body mass index, Anesthesia, general, Microcirculation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 26 Apr 2023 (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.
The purpose of this study was to investigate the effect of obesity on changes in microvascular reactivity and tissue oxygen saturation (StO2) during general anesthesia using near-infrared spectroscopy in conjunction with vascular occlusion tests (VOT).
For this prospective observation investigation, a total of 128 patients who underwent elective surgery under general anesthesia at Pusan National University Hospital between June 2018 and February 2021 were participated in this study. Baseline StO2 on thenar eminence, hemodynamics, and laboratory profile were monitored before (Tpre) and 30 min after general anesthesia (Tpost). During vascular occlusion tests (VOT), the occlusion slope representing oxygen consumption of muscle and recovery slope representing microvascular reactivity were also collected at Tpre and Tpost. For analysis, the patients were divided into two groups: overweight (body mass index [BMI] ≥ 25 kg/m2) and normal weight (BMI < 25).
Detailed description
Preoperative laboratory findings were obtained. Mean blood pressure (MBP), pulse oxygen saturation (SpO2), heart rate (HR), skin temperature, and VOT-derived measurements, including baseline tissue oxygen saturation (StO2), occlusion slope, minimum StO2, time to minimum StO2, recovery slope, maximum StO2, and time to baseline StO2 were recorded before (Tpre) and 30 min after general anesthesia (Tpost).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| overweight group | – | Device: Near-infrared spectroscopy monitorSubjects with a body mass index (BMI) ≥ 25 |
| normal weight group | – | Device: Near-infrared spectroscopy monitorSubjects with BMI < 25 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who underwent elective surgery under general anesthesia between 2018 and 2021 in Pusan national univ. hospital.
Key inclusion criteria (1 listed)
- Subjects who underwent elective surgery under general anesthesia.
Key exclusion criteria (10 listed)
- Society of Anesthesiologists (ASA) physical status > II
- patients with a neuraxial block
- uncontrolled hypertension
- patients with major cardiovascular disease
- diabetes
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 |
|---|---|---|
| Near-infrared spectroscopy monitortissue oxygen saturation monitoring combined with vascular occlusion test | Device | normal weight group, overweight group |
Primary outcome
Recovery slope after general aneshtesia (Tpost)
Time frame: 10 minutes
Representing microvascular reactivity (Tpost: 30 minutes after general anesthesia); recovery slope was calculated from deflation of the tourniquet until the recovery of StO2 to the baseline value.
3 secondary outcomes
Recovery slope before general aneshtesia (Tpre)
Time frame: 10 minutes
Occlusion slope before general anesthesia (Tpre)
Time frame: 10 minutes
Occlusion slope before general anesthesia (Tpost)
Time frame: 10 minutes
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 17 Oct 2023.
- Background: PubMed 33526968Cho AR, Lee HJ, Kim HJ, Do W, Jeon S, Baek SH, Kim ES, Kwon JY, Kim HK. Microvascular Reactivity Measured by Dynamic Near-infrared Spectroscopy Following Induction of General Anesthesia in Healthy Patients: Observation of Age-related Change. Int J Med Sci. 2021 Jan 1;18(5):1096-1103. doi: 10.7150/ijms.52433. eCollection 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Obesity and 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 1 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 17 Oct 2023. 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?
Recovery slope after general aneshtesia (Tpost) (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05829785, which also lists 1 linked publication.
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 17 Oct 2023.