xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05993481</url>
    </required_header>
    <id_info>
      <org_study_id>Study Interval</org_study_id>
      <nct_id>NCT05993481</nct_id>
    </id_info>
    <brief_title>The Noninvasive Blood Pressure Measurement Effect on the Hypotension</brief_title>
    <official_title>The Effect of More Frequent Noninvasive Blood Pressure Measurement on the Detection of Intraoperative Hypotension</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Konya City Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Bakırkoy Dr. Sadi Konuk Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Cleveland Clinic</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Konya City Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Around 300 million surgical operations are performed globally, and of these, 40 to 50 million&#xD;
        are performed in the USA. The perioperative period is characterized by hemodynamic&#xD;
        instability and, most importantly, hypotension. Intraoperative hypotension is frequent, and&#xD;
        the incidence ranges between 5% and 99% during non-cardiac surgery, depending on the&#xD;
        definition.&#xD;
  &#xD;
        The aim of the study is determined as the relationship between two different time intervals&#xD;
        of measurements and time spent hypotensive under harm thresholds in non-cardiac surgery in&#xD;
        adults having non-cardiac surgery. Secondarily, it will be determined if more frequent&#xD;
        non-invasive blood pressure measurement use decreases postoperative acute kidney injury.&#xD;
        Exploratory, it will be evaluated if more frequent non-invasive blood pressure use causes&#xD;
        pain or nerve injury in the arms or not.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Around 300 million surgical operations are performed globally, and of these, 40 to 50 million&#xD;
        are performed in the USA. The perioperative period is characterized by hemodynamic&#xD;
        instability and, most importantly, hypotension. Intraoperative hypotension is frequent, and&#xD;
        the incidence ranges between 5% and 99% during non-cardiac surgery, depending on the&#xD;
        definition.&#xD;
  &#xD;
        Intraoperative hypotension can cause an ischemia-reperfusion injury, manifesting as&#xD;
        dysfunction of any vital organ. The kidneys and the heart are the most sensitive organs to be&#xD;
        affected. Numerous analyses in diverse non-cardiac surgical populations demonstrate&#xD;
        clinically meaningful associations between intraoperative hypotension and myocardial injury,&#xD;
        acute kidney injury, serious composite complications, and death. The association between&#xD;
        hypotension and various complications seems clear. However, hypotension exposure time&#xD;
        provokes acute kidney remains unclear.&#xD;
  &#xD;
        Myocardial injury after non-cardiac surgery manifests as an acute increase in the&#xD;
        concentration of cardiac biomarkers and occurs in 11.6% of non-cardiac surgeries. Myocardial&#xD;
        injury after non-cardiac surgery is also associated with a hypotension period, even with only&#xD;
        small biomarker increases. Ischemia-reperfusion injury due to hypotension may substantially&#xD;
        contribute to postoperative myocardial injury.&#xD;
  &#xD;
        Acute kidney injury (AKI) is defined as creatinine increase and urine output and is&#xD;
        well-validated in medical patients. Acute kidney injury reportedly prolongs hospitalization&#xD;
        and increases readmissions; it is also associated with increased healthcare costs, sepsis,&#xD;
        and mortality. However, most of the data regarding outcomes of acute kidney injury originate&#xD;
        from cohorts of hospitalized medical patients, patients admitted to critical care units, or&#xD;
        trauma victims. Postoperative kidney injury can increase after surgery because of dehydration&#xD;
        or surgical muscle injury. Furthermore, a recent study found a strong relationship between&#xD;
        intraoperative hypotension exposure and non-cardiac surgery-related acute kidney injury in&#xD;
        patients &lt;60 years of age. However, another study found no independent association between&#xD;
        varying ages and postoperative acute kidney injury without evaluating intraoperative&#xD;
        hypotension exposure.&#xD;
  &#xD;
        The definition of intraoperative hypotension is that a mean arterial pressure (MAP) of 65 mm&#xD;
        Hg is accepted as a threshold predicting myocardial injury, which is a leading cause of&#xD;
        30-day postoperative mortality. Additionally, the risk of end-organ dysfunction increases&#xD;
        with the length of low arterial blood pressure. According to Walsh et al., as little as 1&#xD;
        minute of exposure to MAP &lt;55 mm Hg is associated with myocardial injury, any cardiac&#xD;
        complication, and kidney injury after non-cardiac surgery.&#xD;
  &#xD;
        The American Society of Anesthesiologists (ASA) &quot;Standards for Basic Anesthetic Monitoring&quot;&#xD;
        require measurement and evaluation of arterial blood pressure (BP) at least every five&#xD;
        minutes except &quot;under extenuating circumstances,&quot; but acknowledge that &quot;brief interruptions&#xD;
        of continual monitoring may be unavoidable.&quot; The standards apply to all patients undergoing&#xD;
        anesthetics (general, regional, or monitored anesthesia care). Intraoperative blood pressure&#xD;
        can be measured oscillometrically, usually at 5 minutes intervals, or continuously with an&#xD;
        arterial catheter. However, when patients are hemodynamically unstable, the non-invasive&#xD;
        blood pressure measurement interval of 5 minutes may be insufficient to assess rapidly&#xD;
        changing hemodynamics accurately. Subsequently, the provider sometimes inadvertently fails to&#xD;
        re-engage the cyclic measurement of cuff blood pressure. This leads to extended periods when&#xD;
        hypotension is not measured, thus potentially compromising patient safety.&#xD;
  &#xD;
        Arterial catheters are generally used to monitor hemodynamic fluctuations for certain complex&#xD;
        operations and patients with significant comorbidities. Recent studies even suggest that only&#xD;
        a few minutes of hypotension in the acute care setting increases the incidence of&#xD;
        complications. These observations strongly suggest that continuous blood pressure monitoring&#xD;
        is critical in the acute care setting to identify periods of hypertension and/or hypotension&#xD;
        as early as possible. Today, the gold standard for blood pressure monitoring is the invasive&#xD;
        arterial line, a catheter inserted into an artery, which enables continuous blood pressure&#xD;
        monitoring.&#xD;
  &#xD;
        On the other hand, it is impossible to place the arterial catheter on all patients because of&#xD;
        invasiveness and complications. One extensive study on the topic, in a systematic review,&#xD;
        assessed the complications associated with an arterial catheter in &gt;25 000 cases. In this&#xD;
        study, temporary artery occlusion was the most frequent complication ranging from 1.5 to 35%&#xD;
        (average: 19.7%). Hematomas were the second most common complication, with an incidence of&#xD;
        14.4%. Serious complications such as permanent occlusion, pseudoaneurysm, and sepsis occurred&#xD;
        in 0.09%, 0.09%, and 0.13% of cases, respectively.&#xD;
  &#xD;
        Therefore, the aim of the study will be determined as the relationship between two different&#xD;
        time intervals of measurements and time spend hypotensive under harm thresholds in&#xD;
        non-cardiac surgery in adults having non-cardiac surgery. Secondarily, it will be determined&#xD;
        if more frequent non-invasive blood pressure measurement use decreases postoperative acute&#xD;
        kidney injury. Exploratory, it will be evaluated if more frequent non-invasive blood pressure&#xD;
        use causes pain or nerve injury in the arms or not.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The time-average spend hypotensive (under MAP thresholds of 65 mmHg) for at least 1 minute</measure>
      <time_frame>Every 2.5 minute in the surgery upto end of the surgery.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>the time-average spend hypotensive (under MAP thresholds of &lt;60, &lt;50, and &lt;40 mmHg [mmHg]) for at least 1 minute.</measure>
      <time_frame>Every 2.5 minute in the surgery upto end of the surgery.</time_frame>
      <description>For the secondary outcomes, clinically important difference will be the time-average spend hypotensive (under MAP thresholds of &lt;60, &lt;50, and &lt;40 mmHg [mmHg]) for at least 1 minute, and absolute [n] and relative [%] number of patients with any MAP measurement &lt;65, &lt;60, &lt;50, and &lt;40mmHg, absolute [n] and relative [%] number of patients with at least one 1-minute episode of a MAP &lt;65, &lt;60, &lt;50, and &lt;40 mmHg, time-weighted average MAP &gt;100, &gt;110, &gt;120, &gt;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]</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Postoperative complications after surgery including acute myocardial infarction, acute kidney injury, non-fatal cardiac arrest, peripheral nerve injuries, arm pain and death</measure>
      <time_frame>Postoperative time until 24th hours.</time_frame>
      <description>The exploratory outcomes will be Postoperative complications after surgery including acute myocardial infarction, acute kidney injury, non-fatal cardiac arrest, peripheral nerve injuries, arm pain and death, a 2.5-minute interval group of intraoperative blood measurement compared to standard 5-minute interval group, 2 hours after surgery in the post-anesthesia recovery unit and after 24 hours.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">640</enrollment>
    <condition>Hypotension During Surgery</condition>
    <arm_group>
      <arm_group_label>5 min. BP</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Clinicians will carry out randomized treatments in coordination with research staff.&#xD;
  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&lt; 60 mmHg. However, the dose of each will be titrated as necessary to reach the target mean arterial pressures.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>2.5 min. BP</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Clinicians will carry out randomized treatments in coordination with research staff.&#xD;
  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.&#xD;
  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&lt; 60 mmHg. However, the dose of each will be titrated as necessary to reach the target mean arterial pressures.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Blood Pressure Measurement</intervention_name>
      <description>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.&#xD;
  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.</description>
      <arm_group_label>2.5 min. BP</arm_group_label>
      <arm_group_label>5 min. BP</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age &gt; 18 years;&#xD;
  &#xD;
            2. ASA Physical Status 3 and 4;&#xD;
  &#xD;
            3. Non-cardiac surgery with expected surgery duration ≥ 2 hours;&#xD;
  &#xD;
            4. Supine position during the surgery;&#xD;
  &#xD;
            5. Regional or general anesthesia;&#xD;
  &#xD;
            6. Planned hospital stay time of at least 24 hours.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients who confirm to be pregnant and/or nursing mothers;&#xD;
  &#xD;
            2. Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s);&#xD;
  &#xD;
            3. Has a condition that precludes routine or tight blood pressure management;&#xD;
  &#xD;
            4. Mean arterial blood pressure differences between right and left arm ≥ 5 mmHg;&#xD;
  &#xD;
            5. Patient who has physically disabled their arms:&#xD;
  &#xD;
          5. Emergency surgery.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yasin Tire, Assoc. Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Konya City Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yasin Tire, Assoc. Prof.</last_name>
      <phone>+905055367970</phone>
      <email>dryasintire@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Gökhan Sertçakacılar, Assoc. Prof.</last_name>
      <phone>+905053130818</phone>
      <email>gokhansertcakacilar@hotmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Konya City Hospital</name>
        <address>
          <city>Konya</city>
          <state>Meram</state>
          <zip>42140</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yasin Tire</last_name>
        <phone>05055367970</phone>
        <email>dryasintire@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Konya City Hospital</investigator_affiliation>
      <investigator_full_name>Yasin Tire, MD</investigator_full_name>
      <investigator_title>Assoc. Prof. Dr. Yasin Tire</investigator_title>
    </responsible_party>
    <keyword>Intraoperative Hypotension</keyword>
    <keyword>Noninvasive Blood pressure measurement</keyword>
    <keyword>More frequent time interval</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypotension</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05993481
  org study id: Study Interval
  nct id: NCT05993481
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: Double (Participant, Investigator)
  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.
  description: 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.
  measure: 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.
  description: 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]
  measure: Postoperative complications after surgery including acute myocardial infarction, acute kidney injury, non-fatal cardiac arrest, peripheral nerve injuries, arm pain and death
  time frame: Postoperative time until 24th hours.
  description: The exploratory outcomes will be Postoperative complications after surgery including acute myocardial infarction, acute kidney injury, non-fatal cardiac arrest, peripheral nerve injuries, arm pain and death, a 2.5-minute interval group of intraoperative blood measurement compared to standard 5-minute interval group, 2 hours after surgery in the post-anesthesia recovery unit and after 24 hours.
  arm group label: 5 min. BP
  arm group type: Active Comparator
  description: 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.
  arm group label: 2.5 min. BP
  arm group type: Active Comparator
  description: 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.
  intervention type: Diagnostic Test
  intervention name: Blood Pressure Measurement
  description: 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.
  arm group label: 2.5 min. BP
  arm group label: 5 min. BP
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yasin Tire, Assoc. Prof.
  role: Principal Investigator
  affiliation: Konya City Hospital
  last name: Yasin Tire, Assoc. Prof.
  phone: +905055367970
  email: dryasintire@hotmail.com
  last name: Gökhan Sertçakacılar, Assoc. Prof.
  phone: +905053130818
  email: gokhansertcakacilar@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Konya City Hospital
  investigator full name: Yasin Tire, MD
  investigator title: Assoc. Prof. Dr. Yasin Tire
  mesh term: Hypotension