Anesthesia, GeneralNCT05792436
Continuous Versus 1-min Oscillometric Arterial BP Monitoring
A study testing 1-min interval oscillometric method and arterial catheterization method in people with Anesthesia, General, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
Hypotension is common during surgery and about one-third of hypotension occur during the period from anesthesia induction to skin incision. Therefore, monitoring blood pressure during this period is crucial. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- 1-min interval oscillometric method and arterial catheterization method
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 27 Apr 2023to 21 Aug 2025
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 19 or older undergoing scheduled non-cardiac surgery with general anesthesia and continuous invasive arterial blood pressure monitoring via the radial artery
Who cannot join
- Arterial access is clinically necessary before induction of anesthesia (e.g., moderate or higher degree of aortic stenosis, moderate or higher degree of heart failure, coronary artery disease requiring revascularization, intracranial aneurysm with a significant risk of rupture, etc.)
- Emergency surgery
- American Society of Anesthesiologists (ASA) physical status 5 or 6
- Arterial access is required in a different artery other than the radial artery (e.g., the femoral artery)
- Electrocardiogram other than sinus rhythm
- Refusal to participate in the study
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Hospital
Seoul, Seoul, 03080
Korea University Guro Hospital
Seoul
About this study
Official title: Continuous Invasive Versus 1-min Interval Oscillometric Arterial Pressure Monitoring and Hypotension During Induction of Anesthesia: a Bicenter, Randomized, Noninferiority Trial
Hypotension is common during surgery and about one-third of hypotension occur during the period from anesthesia induction to skin incision. Therefore, monitoring blood pressure during this period is crucial.
Two methods are used for measuring blood pressure during surgery: the intermittent measurement method (oscillometric method) and the continuous measurement method (arterial catheterization method). The latter is frequently used in surgical patients who require meticulous hemodynamic management, although there is no clearly defined indication for its use. Despite the benefits of arterial catheterization, it is often delayed after induction of general anesthesia, and blood pressure is monitored intermittently using the oscillometric method.
Read more
A recent study showed that continuous arterial pressure monitoring using arterial catheterization method during the induction of general anesthesia reduced hypotension significantly compared to 2.5-min interval intermittent arterial pressure monitoring using oscillometric method. The study was conducted on patients scheduled for continuous arterial pressure monitoring during surgery and the group with continuous arterial pressure monitoring showed significantly lower incidence of hypotension during the first 15 minutes of anesthesia induction.
However, measuring blood pressure using the oscillometric method at 1-min interval, rather than 2.5-min interval, may not be significantly inferior to continuous monitoring via arterial catheterization in terms of hypotension occurrence. This study aims to compare hypotension incidence between arterial catheterization method and oscillometric method with 1-min interval during induction of anesthesia in non-cardiac surgery patients.
- Conditions
- Anesthesia, General
- Being tested
- 1-min interval oscillometric method, arterial catheterization method
- Keywords
- Intraoperative hypotention, Induction of anesthesia, Arterial blood pressure monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-min interval oscillometric methodDevice
Before induction of anesthesia, 20-gauge catheter is inserted to radial artery after local anesthesia with lidocaine, and continuous blood pressure monitoring is started. Anesthesia is induced using propofol, opioids (fentanyl or remifentanil), and neuromuscular relaxants (rocuronium, cisatracurium, or vecuronium). For maintenance of anesthesia, propofol infusion or inhalation anesthetics (sevoflurane or desflurane) are used.
From the start of anesthesia induction to 15 minutes after, arterial blood pressure is monitored at 1-min interval using oscillometric method. The display of continuous arterial pressure on the anesthesia monitor is turned off during the 15-min study period.
arterial catheterization methodDevice
During the same time window for 1-min interval oscillometric method, arterial blood pressure is monitored using continuous blood pressure monitoring.
| Study group | Role | What they receive |
|---|---|---|
| 1-min interval oscillometric method | Experimental | 1-min interval blood pressure monitoring using oscillometric method during induction of anesthesia Receives: Device: 1-min interval oscillometric method |
| arterial catheterization method | Active comparator | Continuous blood pressure monitoring through arterial catheter during induction of anesthesia Receives: Device: arterial catheterization method |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAP integral
The area under the mean arterial pressure (MAP) of 65 mmHg calculated using the MAP recorded every second
Measured: From the start of anesthesia induction to 15 minutes after
Secondary outcomes (9)
Area under MAP of 60, 50, 40 mmHg (mmHg∙min)
calculated using the MAP recorded every second
Measured: From the start of anesthesia induction to 15 minutes after
Duration of MAP <65, <60, <50, <40 mmHg (min)
calculated using the MAP recorded every second
Measured: From the start of anesthesia induction to 15 minutes after
Exposure to MAP <65, <60, <50, and <40 mmHg (binary)
calculated using the MAP recorded every second
Measured: From the start of anesthesia induction to 15 minutes after
Exposure to continuous MAP <65, <60, <50, <40 mmHg for 1 minute or longer (binary)
calculated using the MAP recorded every second
Measured: From the start of anesthesia induction to 15 minutes after
Area above MBP of 100, 110, 120, 140 mmHg (mmHg∙min)
calculated using the MAP recorded every second
Measured: From the start of anesthesia induction to 15 minutes after
MAP standard deviation (mmHg)
calculated using the MAP recorded every second
Measured: From the start of anesthesia induction to 15 minutes after
Use of vasopressor (binary)
ephedrine, phenylephrine, norepinephrine (binary)
Measured: From the start of anesthesia induction to 15 minutes after
Use of vasopressor (dose)
ephedrine (mg), phenylephrine (μg/kg), norepinephrine (μg/kg)
Measured: From the start of anesthesia induction to 15 minutes after
Crystalloid (ml)
Total amount of crystalloid administered
Measured: From the start of anesthesia induction to 15 minutes after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start27 Apr 2023
- Primary completion21 Aug 2025
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karam Nam, MD, Seoul National University Hospital
- Investigators
- Karam Nam, MD, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792436
- Sponsor's protocol ID
- SPROUT-2
- Status last verified
- Jan 2026
- First submitted
- 18 Mar 2023
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Invasive Versus 1-min Interval Oscillometric Arterial Pressure Monitoring and Hypotension During Induction of Anesthesia: a Bicenter, Randomized, Noninferiority Trial
- ClinicalTrials.gov ID
- NCT05792436
- Acronym / sponsor ID
- SPROUT-2
- Conditions
- Anesthesia, General
- Keywords
- Intraoperative hypotention, Induction of anesthesia, Arterial blood pressure monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 31 Mar 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.
Hypotension is common during surgery and about one-third of hypotension occur during the period from anesthesia induction to skin incision. Therefore, monitoring blood pressure during this period is crucial.
Two methods are used for measuring blood pressure during surgery: the intermittent measurement method (oscillometric method) and the continuous measurement method (arterial catheterization method). The latter is frequently used in surgical patients who require meticulous hemodynamic management, although there is no clearly defined indication for its use. Despite the benefits of arterial catheterization, it is often delayed after induction of general anesthesia, and blood pressure is monitored intermittently using the oscillometric method.
A recent study showed that continuous arterial pressure monitoring using arterial catheterization method during the induction of general anesthesia reduced hypotension significantly compared to 2.5-min interval intermittent arterial pressure monitoring using oscillometric method. The study was conducted on patients scheduled for continuous arterial pressure monitoring during surgery and the group with continuous arterial pressure monitoring showed significantly lower incidence of hypotension during the first 15 minutes of anesthesia induction.
However, measuring blood pressure using the oscillometric method at 1-min interval, rather than 2.5-min interval, may not be significantly inferior to continuous monitoring via arterial catheterization in terms of hypotension occurrence. This study aims to compare hypotension incidence between arterial catheterization method and oscillometric method with 1-min interval during induction of anesthesia in non-cardiac surgery patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-min interval oscillometric method | Experimental | Device: 1-min interval oscillometric method1-min interval blood pressure monitoring using oscillometric method during induction of anesthesia |
| arterial catheterization method | Active comparator | Device: arterial catheterization methodContinuous blood pressure monitoring through arterial catheter during induction of anesthesia |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged 19 or older undergoing scheduled non-cardiac surgery with general anesthesia and continuous invasive arterial blood pressure monitoring via the radial artery
Key exclusion criteria (6 listed)
- Arterial access is clinically necessary before induction of anesthesia (e.g., moderate or higher degree of aortic stenosis, moderate or higher degree of heart failure, coronary artery disease requiring revascularization, intracranial aneurysm with a significant risk of rupture, etc.)
- Emergency surgery
- American Society of Anesthesiologists (ASA) physical status 5 or 6
- Arterial access is required in a different artery other than the radial artery (e.g., the femoral artery)
- Electrocardiogram other than sinus rhythm
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 |
|---|---|---|
| 1-min interval oscillometric methodBefore induction of anesthesia, 20-gauge catheter is inserted to radial artery after local anesthesia with lidocaine, and continuous blood pressure monitoring is started. Anesthesia is induced using propofol, opioids (fentanyl or remifentanil), and neuromuscular relaxants (rocuronium, cisatracurium, or vecuronium). For maintenance of anesthesia, propofol infusion or inhalation anesthetics (sevoflurane or desflurane) are used. From the start of anesthesia induction to 15 minutes after, arterial blood pressure is monitored at 1-min interval using oscillometric method. The display of continuous arterial pressure on the anesthesia monitor is turned off during the 15-min study period. | Device | 1-min interval oscillometric method |
| arterial catheterization methodDuring the same time window for 1-min interval oscillometric method, arterial blood pressure is monitored using continuous blood pressure monitoring. | Device | arterial catheterization method |
Primary outcome
MAP integral
Time frame: From the start of anesthesia induction to 15 minutes after
The area under the mean arterial pressure (MAP) of 65 mmHg calculated using the MAP recorded every second
9 secondary outcomes
Area under MAP of 60, 50, 40 mmHg (mmHg∙min)
Time frame: From the start of anesthesia induction to 15 minutes after
Duration of MAP <65, <60, <50, <40 mmHg (min)
Time frame: From the start of anesthesia induction to 15 minutes after
Exposure to MAP <65, <60, <50, and <40 mmHg (binary)
Time frame: From the start of anesthesia induction to 15 minutes after
Exposure to continuous MAP <65, <60, <50, <40 mmHg for 1 minute or longer (binary)
Time frame: From the start of anesthesia induction to 15 minutes after
Area above MBP of 100, 110, 120, 140 mmHg (mmHg∙min)
Time frame: From the start of anesthesia induction to 15 minutes after
MAP standard deviation (mmHg)
Time frame: From the start of anesthesia induction to 15 minutes after
Use of vasopressor (binary)
Time frame: From the start of anesthesia induction to 15 minutes after
Use of vasopressor (dose)
Time frame: From the start of anesthesia induction to 15 minutes after
Crystalloid (ml)
Time frame: From the start of anesthesia induction to 15 minutes after
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 30 Jan 2026.
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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.
Karam Nam, MD study director
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1-min interval oscillometric method and arterial catheterization method in people with Anesthesia, General, run by Seoul National University Hospital at 2 sites 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 6 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 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
MAP integral (time frame: From the start of anesthesia induction to 15 minutes after). 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 30 Jan 2026.