Hypotension During SurgeryNCT05993481
The Noninvasive Blood Pressure Measurement Effect on the Hypotension
A study testing Blood Pressure Measurement in people with Hypotension During Surgery, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Around 300 million surgical operations are performed globally, and of these, 40 to 50 million are performed in the USA. The perioperative period is characterized by hemodynamic instability and, most importantly, hypotension. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypotension During Surgery
- What is being tested?
- Blood Pressure Measurement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2024to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years;
- ASA Physical Status 1 and 3;
- Non-cardiac surgery with expected surgery duration ≥ 2 hours;
- Supine position during the surgery;
- Regional or general anesthesia;
- Planned hospital stay time of at least 24 hours.
Who cannot join
- Patients who confirm to be pregnant and/or nursing mothers;
- Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s);
- Has a condition that precludes routine or tight blood pressure management;
- Mean arterial blood pressure differences between right and left arm ≥ 5 mmHg;
- Patient who has physically disabled their arms:
- 5. Emergency surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of More Frequent Noninvasive Blood Pressure Measurement on the Detection of Intraoperative Hypotension
Around 300 million surgical operations are performed globally, and of these, 40 to 50 million are performed in the USA. The perioperative period is characterized by hemodynamic instability and, most importantly, hypotension. Intraoperative hypotension is frequent, and the incidence ranges between 5% and 99% during non-cardiac surgery, depending on the definition.
The aim of the study is determined as the relationship between two different time intervals of measurements and time spent hypotensive under harm thresholds in non-cardiac surgery in adults having non-cardiac surgery. Secondarily, it will be determined if more frequent non-invasive blood pressure measurement use decreases postoperative acute kidney injury. Exploratory, it will be evaluated if more frequent non-invasive blood pressure use causes pain or nerve injury in the arms or not.
Read the detailed description
Around 300 million surgical operations are performed globally, and of these, 40 to 50 million are performed in the USA. The perioperative period is characterized by hemodynamic instability and, most importantly, hypotension. Intraoperative hypotension is frequent, and the incidence ranges between 5% and 99% during non-cardiac surgery, depending on the definition.
Intraoperative hypotension can cause an ischemia-reperfusion injury, manifesting as dysfunction of any vital organ. The kidneys and the heart are the most sensitive organs to be affected. Numerous analyses in diverse non-cardiac surgical populations demonstrate clinically meaningful associations between intraoperative hypotension and myocardial injury, acute kidney injury, serious composite complications, and death. The association between hypotension and various complications seems clear. However, hypotension exposure time provokes acute kidney remains unclear.
Myocardial injury after non-cardiac surgery manifests as an acute increase in the concentration of cardiac biomarkers and occurs in 11.6% of non-cardiac surgeries. Myocardial injury after non-cardiac surgery is also associated with a hypotension period, even with only small biomarker increases. Ischemia-reperfusion injury due to hypotension may substantially contribute to postoperative myocardial injury.
Acute kidney injury (AKI) is defined as creatinine increase and urine output and is well-validated in medical patients. Acute kidney injury reportedly prolongs hospitalization and increases readmissions; it is also associated with increased healthcare costs, sepsis, and mortality. However, most of the data regarding outcomes of acute kidney injury originate from cohorts of hospitalized medical patients, patients admitted to critical care units, or trauma victims. Postoperative kidney injury can increase after surgery because of dehydration or surgical muscle injury. Furthermore, a recent study found a strong relationship between intraoperative hypotension exposure and non-cardiac surgery-related acute kidney injury in patients <60 years of age. However, another study found no independent association between varying ages and postoperative acute kidney injury without evaluating intraoperative hypotension exposure.
The definition of intraoperative hypotension is that a mean arterial pressure (MAP) of 65 mm Hg is accepted as a threshold predicting myocardial injury, which is a leading cause of 30-day postoperative mortality. Additionally, the risk of end-organ dysfunction increases with the length of low arterial blood pressure. According to Walsh et al., as little as 1 minute of exposure to MAP <55 mm Hg is associated with myocardial injury, any cardiac complication, and kidney injury after non-cardiac surgery.
The American Society of Anesthesiologists (ASA) "Standards for Basic Anesthetic Monitoring" require measurement and evaluation of arterial blood pressure (BP) at least every five minutes except "under extenuating circumstances," but acknowledge that "brief interruptions of continual monitoring may be unavoidable." The standards apply to all patients undergoing anesthetics (general, regional, or monitored anesthesia care). Intraoperative blood pressure can be measured oscillometrically, usually at 5 minutes intervals, or continuously with an arterial catheter. However, when patients are hemodynamically unstable, the non-invasive blood pressure measurement interval of 5 minutes may be insufficient to assess rapidly changing hemodynamics accurately. Subsequently, the provider sometimes inadvertently fails to re-engage the cyclic measurement of cuff blood pressure. This leads to extended periods when hypotension is not measured, thus potentially compromising patient safety.
Arterial catheters are generally used to monitor hemodynamic fluctuations for certain complex operations and patients with significant comorbidities. Recent studies even suggest that only a few minutes of hypotension in the acute care setting increases the incidence of complications. These observations strongly suggest that continuous blood pressure monitoring is critical in the acute care setting to identify periods of hypertension and/or hypotension as early as possible. Today, the gold standard for blood pressure monitoring is the invasive arterial line, a catheter inserted into an artery, which enables continuous blood pressure monitoring.
On the other hand, it is impossible to place the arterial catheter on all patients because of invasiveness and complications. One extensive study on the topic, in a systematic review, assessed the complications associated with an arterial catheter in >25 000 cases. In this study, temporary artery occlusion was the most frequent complication ranging from 1.5 to 35% (average: 19.7%). Hematomas were the second most common complication, with an incidence of 14.4%. Serious complications such as permanent occlusion, pseudoaneurysm, and sepsis occurred in 0.09%, 0.09%, and 0.13% of cases, respectively.
Therefore, the aim of the study will be determined as the relationship between two different time intervals of measurements and time spend hypotensive under harm thresholds in non-cardiac surgery in adults having non-cardiac surgery. Secondarily, it will be determined if more frequent non-invasive blood pressure measurement use decreases postoperative acute kidney injury. Exploratory, it will be evaluated if more frequent non-invasive blood pressure use causes pain or nerve injury in the arms or not.
- Conditions
- Hypotension During Surgery
- Being tested
- Blood Pressure Measurement
- Keywords
- Intraoperative Hypotension, Noninvasive Blood pressure measurement, More frequent time interval
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Pressure MeasurementDiagnostic test
NIBP measurements will be recorded intraoperatively every 2.5 minutes for the group of 2.5 min. Blood pressure management or every 5 minutes for the other group of 5 min. Blood pressure management after providing randomization before the surgery. A calibrated and time-matched same type of standard anesthetic monitor will be used. The monitor will measure blood pressure and display the mean, systolic and diastolic values.
All blood pressure measurements will be discontinued before the PACU transfer. Data will be automatically downloaded from the monitor to a computer using a software interface program.
| Study group | Role | What they receive |
|---|---|---|
| 5 min. BP | Active comparator | Clinicians will carry out randomized treatments in coordination with research staff.
The treatments will be: 1) Ephedrine treatment to maintain intraoperative MAP ≥60 mmHg, delayed resumption of chronic antihypertensive medications as monitoring with 5 min. Blood pressure management. The staff anesthesiologist will administer an ephedrine sulfate injection. An initial dose of 5 to 10 mg given as an intravenous bolus is advised for the treatment of clinically significant hypotension during anesthesia to provide an increase in blood pressure in case of MAP< 60 mmHg. However, the dose of each will be titrated as necessary to reach the target mean arterial pressures. Receives: Diagnostic Test: Blood Pressure Measurement |
| 2.5 min. BP | Active comparator | Clinicians will carry out randomized treatments in coordination with research staff.
The treatments will be: 2) Ephedrine treatment to maintain intraoperative MAP ≥60 mmHg, delayed resumption of chronic antihypertensive medications as monitoring with 2.5 min. Blood pressure management.
The staff anesthesiologist will administer an ephedrine sulfate injection. An initial dose of 5 to 10 mg given as an intravenous bolus is advised for the treatment of clinically significant hypotension during anesthesia to provide an increase in blood pressure in case of MAP< 60 mmHg. However, the dose of each will be titrated as necessary to reach the target mean arterial pressures. Receives: Diagnostic Test: Blood Pressure Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time-average spend hypotensive (under MAP thresholds of 65 mmHg) for at least 1 minute
For the primary outcome, clinically important difference will be the time-average spend hypotensive (under MAP thresholds of 65 mmHg) for at least 1 minute since it has been shown clinically important in previous studies . We will assess this primary outcome in adults having non-cardiac surgery, a 2.5-minute interval of intraoperative blood measurement group compared to the standard 5-minute interval group.
Measured: Every 2.5 minute in the surgery upto end of the surgery.
Secondary outcomes (1)
the time-average spend hypotensive (under MAP thresholds of <60, <50, and <40 mmHg [mmHg]) for at least 1 minute.
For the secondary outcomes, clinically important difference will be the time-average spend hypotensive (under MAP thresholds of <60, <50, and <40 mmHg [mmHg]) for at least 1 minute, and absolute [n] and relative [%] number of patients with any MAP measurement <65, <60, <50, and <40mmHg, absolute [n] and relative [%] number of patients with at least one 1-minute episode of a MAP <65, <60, <50, and <40 mmHg, time-weighted average MAP >100, >110, >120, >140mmHg [mmHg], time-weighted cumulative amount of ephedrine indexed to body weight [µg kg-1 min-1], cumulative amount of administered fluids indexed to surgical duration [mL min-1]
Measured: Every 2.5 minute in the surgery upto end of the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start25 Oct 2024
- Primary completion25 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension During SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital, The Cleveland Clinic
- Responsible party
- Principal investigator, Yasin Tire, MD, Konya City Hospital
- Investigators
- Yasin Tire, Assoc. Prof., Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993481
- Sponsor's protocol ID
- Study Interval
- Status last verified
- Dec 2025
- First submitted
- 27 Jul 2023
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of More Frequent Noninvasive Blood Pressure Measurement on the Detection of Intraoperative Hypotension
- ClinicalTrials.gov ID
- NCT05993481
- Acronym / sponsor ID
- Study Interval
- Conditions
- Hypotension During Surgery
- Keywords
- Intraoperative Hypotension, Noninvasive Blood pressure measurement, More frequent time interval
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Collaborators
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital, The Cleveland Clinic
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 25 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 15 Aug 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.
Around 300 million surgical operations are performed globally, and of these, 40 to 50 million are performed in the USA. The perioperative period is characterized by hemodynamic instability and, most importantly, hypotension. Intraoperative hypotension is frequent, and the incidence ranges between 5% and 99% during non-cardiac surgery, depending on the definition.
The aim of the study is determined as the relationship between two different time intervals of measurements and time spent hypotensive under harm thresholds in non-cardiac surgery in adults having non-cardiac surgery. Secondarily, it will be determined if more frequent non-invasive blood pressure measurement use decreases postoperative acute kidney injury. Exploratory, it will be evaluated if more frequent non-invasive blood pressure use causes pain or nerve injury in the arms or not.
Detailed description
Around 300 million surgical operations are performed globally, and of these, 40 to 50 million are performed in the USA. The perioperative period is characterized by hemodynamic instability and, most importantly, hypotension. Intraoperative hypotension is frequent, and the incidence ranges between 5% and 99% during non-cardiac surgery, depending on the definition.
Intraoperative hypotension can cause an ischemia-reperfusion injury, manifesting as dysfunction of any vital organ. The kidneys and the heart are the most sensitive organs to be affected. Numerous analyses in diverse non-cardiac surgical populations demonstrate clinically meaningful associations between intraoperative hypotension and myocardial injury, acute kidney injury, serious composite complications, and death. The association between hypotension and various complications seems clear. However, hypotension exposure time provokes acute kidney remains unclear.
Myocardial injury after non-cardiac surgery manifests as an acute increase in the concentration of cardiac biomarkers and occurs in 11.6% of non-cardiac surgeries. Myocardial injury after non-cardiac surgery is also associated with a hypotension period, even with only small biomarker increases. Ischemia-reperfusion injury due to hypotension may substantially contribute to postoperative myocardial injury.
Acute kidney injury (AKI) is defined as creatinine increase and urine output and is well-validated in medical patients. Acute kidney injury reportedly prolongs hospitalization and increases readmissions; it is also associated with increased healthcare costs, sepsis, and mortality. However, most of the data regarding outcomes of acute kidney injury originate from cohorts of hospitalized medical patients, patients admitted to critical care units, or trauma victims. Postoperative kidney injury can increase after surgery because of dehydration or surgical muscle injury. Furthermore, a recent study found a strong relationship between intraoperative hypotension exposure and non-cardiac surgery-related acute kidney injury in patients <60 years of age. However, another study found no independent association between varying ages and postoperative acute kidney injury without evaluating intraoperative hypotension exposure.
The definition of intraoperative hypotension is that a mean arterial pressure (MAP) of 65 mm Hg is accepted as a threshold predicting myocardial injury, which is a leading cause of 30-day postoperative mortality. Additionally, the risk of end-organ dysfunction increases with the length of low arterial blood pressure. According to Walsh et al., as little as 1 minute of exposure to MAP <55 mm Hg is associated with myocardial injury, any cardiac complication, and kidney injury after non-cardiac surgery.
The American Society of Anesthesiologists (ASA) "Standards for Basic Anesthetic Monitoring" require measurement and evaluation of arterial blood pressure (BP) at least every five minutes except "under extenuating circumstances," but acknowledge that "brief interruptions of continual monitoring may be unavoidable." The standards apply to all patients undergoing anesthetics (general, regional, or monitored anesthesia care). Intraoperative blood pressure can be measured oscillometrically, usually at 5 minutes intervals, or continuously with an arterial catheter. However, when patients are hemodynamically unstable, the non-invasive blood pressure measurement interval of 5 minutes may be insufficient to assess rapidly changing hemodynamics accurately. Subsequently, the provider sometimes inadvertently fails to re-engage the cyclic measurement of cuff blood pressure. This leads to extended periods when hypotension is not measured, thus potentially compromising patient safety.
Arterial catheters are generally used to monitor hemodynamic fluctuations for certain complex operations and patients with significant comorbidities. Recent studies even suggest that only a few minutes of hypotension in the acute care setting increases the incidence of complications. These observations strongly suggest that continuous blood pressure monitoring is critical in the acute care setting to identify periods of hypertension and/or hypotension as early as possible. Today, the gold standard for blood pressure monitoring is the invasive arterial line, a catheter inserted into an artery, which enables continuous blood pressure monitoring.
On the other hand, it is impossible to place the arterial catheter on all patients because of invasiveness and complications. One extensive study on the topic, in a systematic review, assessed the complications associated with an arterial catheter in >25 000 cases. In this study, temporary artery occlusion was the most frequent complication ranging from 1.5 to 35% (average: 19.7%). Hematomas were the second most common complication, with an incidence of 14.4%. Serious complications such as permanent occlusion, pseudoaneurysm, and sepsis occurred in 0.09%, 0.09%, and 0.13% of cases, respectively.
Therefore, the aim of the study will be determined as the relationship between two different time intervals of measurements and time spend hypotensive under harm thresholds in non-cardiac surgery in adults having non-cardiac surgery. Secondarily, it will be determined if more frequent non-invasive blood pressure measurement use decreases postoperative acute kidney injury. Exploratory, it will be evaluated if more frequent non-invasive blood pressure use causes pain or nerve injury in the arms or not.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 min. BP | Active comparator | Diagnostic Test: Blood Pressure MeasurementClinicians will carry out randomized treatments in coordination with research staff. The treatments will be: 1) Ephedrine treatment to maintain intraoperative MAP ≥60 mmHg, delayed resumption of chronic antihypertensive medications as monitoring with 5 min. Blood pressure management. The staff anesthesiologist will administer an ephedrine sulfate injection. An initial dose of 5 to 10 mg given as an intravenous bolus is advised for the treatment of clinically significant hypotension during anesthesia to provide an increase in blood pressure in case of MAP< 60 mmHg. However, the dose of each will be titrated as necessary to reach the target mean arterial pressures. |
| 2.5 min. BP | Active comparator | Diagnostic Test: Blood Pressure MeasurementClinicians will carry out randomized treatments in coordination with research staff. The treatments will be: 2) Ephedrine treatment to maintain intraoperative MAP ≥60 mmHg, delayed resumption of chronic antihypertensive medications as monitoring with 2.5 min. Blood pressure management. The staff anesthesiologist will administer an ephedrine sulfate injection. An initial dose of 5 to 10 mg given as an intravenous bolus is advised for the treatment of clinically significant hypotension during anesthesia to provide an increase in blood pressure in case of MAP< 60 mmHg. However, the dose of each will be titrated as necessary to reach the target mean arterial pressures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years;
- ASA Physical Status 1 and 3;
- Non-cardiac surgery with expected surgery duration ≥ 2 hours;
- Supine position during the surgery;
- Regional or general anesthesia;
Key exclusion criteria (6 listed)
- Patients who confirm to be pregnant and/or nursing mothers;
- Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s);
- Has a condition that precludes routine or tight blood pressure management;
- Mean arterial blood pressure differences between right and left arm ≥ 5 mmHg;
- Patient who has physically disabled their arms:
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 |
|---|---|---|
| Blood Pressure MeasurementNIBP measurements will be recorded intraoperatively every 2.5 minutes for the group of 2.5 min. Blood pressure management or every 5 minutes for the other group of 5 min. Blood pressure management after providing randomization before the surgery. A calibrated and time-matched same type of standard anesthetic monitor will be used. The monitor will measure blood pressure and display the mean, systolic and diastolic values. All blood pressure measurements will be discontinued before the PACU transfer. Data will be automatically downloaded from the monitor to a computer using a software interface program. | Diagnostic test | 2.5 min. BP, 5 min. BP |
Primary outcome
The time-average spend hypotensive (under MAP thresholds of 65 mmHg) for at least 1 minute
Time frame: Every 2.5 minute in the surgery upto end of the surgery.
For the primary outcome, clinically important difference will be the time-average spend hypotensive (under MAP thresholds of 65 mmHg) for at least 1 minute since it has been shown clinically important in previous studies . We will assess this primary outcome in adults having non-cardiac surgery, a 2.5-minute interval of intraoperative blood measurement group compared to the standard 5-minute interval group.
1 secondary outcome
the time-average spend hypotensive (under MAP thresholds of <60, <50, and <40 mmHg [mmHg]) for at least 1 minute.
Time frame: Every 2.5 minute in the surgery upto end of the surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
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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.
Yasin Tire, Assoc. Prof. principal investigator
Konya City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Pressure Measurement in people with Hypotension During Surgery, run by Konya City Hospital at 1 site in Turkey (Türkiye).
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 6 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: enrolling by invitation, as of the sponsor's last update on 29 Dec 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
The time-average spend hypotensive (under MAP thresholds of 65 mmHg) for at least 1 minute (time frame: Every 2.5 minute in the surgery upto end of the surgery.). 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 29 Dec 2025.