<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/NCT02967029</url>
  </required_header>
  <id_info>
    <org_study_id>IstanbulUn</org_study_id>
    <nct_id>NCT02967029</nct_id>
  </id_info>
  <brief_title>Effect of Controlled Hypotension on Cerebral Oxygen Saturation</brief_title>
  <official_title>Effect of Controlled Hypotension on Cerebral Oxygen Saturation in Patients Undergoing Functional Endoscopic Sinus Surgery: a Prospective Randomized Single Blind Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      For a successful functional endoscopic sinus surgery (FESS), it is crucial to provide&#xD;
      effective controlled hypotension to reduce blood loss and provide a relatively blood-free&#xD;
      surgical environment to facilitate surgery.&#xD;
&#xD;
      The goal of controlled hypotension is to maintain an arterial blood pressure which is&#xD;
      sufficiently low to allow a reduction in bleeding with offering a superior intraoperative&#xD;
      hemodynamic stability during stressful surgical events to maintain intact cerebral&#xD;
      microcirculatory auto-regulation.&#xD;
&#xD;
      Auto-regulation impairment during controlled hypotension might increase oxygen extraction&#xD;
      ratio. Thus monitoring the cerebral oxygen saturation (rSO2) to measure cerebral oxygenation&#xD;
      becomes essential and it remains a challenge to clinically assess cerebral oxygenation on a&#xD;
      routine basis.&#xD;
&#xD;
      Various recent studies reported based on facilitating the induction of controlled&#xD;
      hypotension, but the effects of hypotension on cerebral perfusion and oxygenation and its&#xD;
      effects on postoperative cognitive function are still poorly characterized. Moreover, the&#xD;
      relationship between rSO2 and controlled hypotension has not been established in patients&#xD;
      undergoing FESS.&#xD;
&#xD;
      Within the last decade, near infrared spectroscopy (NIRS) INVOS® monitors which is clinically&#xD;
      most broadly spread technique, can be used for non-invasive assessment of cerebral perfusion&#xD;
      by detecting changes in rSO2 by online monitoring of cerebral oxygenation.&#xD;
&#xD;
      In our clinical routine for achieving a controlled hypotension, esmolol and remifentanyl are&#xD;
      the most commonly used hypotensive agents. The aim of this prospective randomized single&#xD;
      blind study was to investigate the influence of remifentanyl as a hypotensive agent in&#xD;
      comparison to esmolol on rSO2 by using NIRS and postoperative cognitive function in patients&#xD;
      undergoing FESS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For a successful functional endoscopic sinus surgery (FESS), it is crucial to provide&#xD;
      effective controlled hypotension to reduce blood loss and provide a relatively blood-free&#xD;
      surgical environment to facilitate surgery.&#xD;
&#xD;
      The goal of controlled hypotension is to maintain an arterial blood pressure which is&#xD;
      sufficiently low to allow a reduction in bleeding with offering a superior intraoperative&#xD;
      hemodynamic stability during stressful surgical events to maintain intact cerebral&#xD;
      microcirculatory auto-regulation.&#xD;
&#xD;
      Auto-regulation impairment during controlled hypotension might increase oxygen extraction&#xD;
      ratio. Thus monitoring the cerebral oxygen saturation (rSO2) to measure cerebral oxygenation&#xD;
      becomes essential and it remains a challenge to clinically assess cerebral oxygenation on a&#xD;
      routine basis.&#xD;
&#xD;
      Various recent studies reported based on facilitating the induction of controlled&#xD;
      hypotension, but the effects of hypotension on cerebral perfusion and oxygenation and its&#xD;
      effects on postoperative cognitive function are still poorly characterized. Moreover, the&#xD;
      relationship between rSO2 and controlled hypotension has not been established in patients&#xD;
      undergoing FESS.&#xD;
&#xD;
      Within the last decade, near infrared spectroscopy (NIRS) monitors which is clinically most&#xD;
      broadly spread technique, can be used for non-invasive assessment of cerebral perfusion by&#xD;
      detecting changes in rSO2 by online monitoring of cerebral oxygenation.&#xD;
&#xD;
      In our clinical routine for achieving a controlled hypotension, esmolol and remifentanyl are&#xD;
      the most commonly used hypotensive agents. The aim of this prospective randomized single&#xD;
      blind study was to investigate the influence of remifentanyl as a hypotensive agent in&#xD;
      comparison to esmolol on rSO2 by using NIRS and postoperative cognitive function in patients&#xD;
      undergoing FESS.&#xD;
&#xD;
      After receiving the local institutional research ethics committee approval and written&#xD;
      informed consent from each patient, 140 American Society of Anesthesiology (ASA) I and II&#xD;
      patients aging between 18 and 65, undergoing for elective FESS and required controlled&#xD;
      hypotension were enrolled in this study. Patients with hypertension, coronary artery diseases&#xD;
      and cerebral insufficiency, severe hypovolemia and anemia, body mass index over 30 kg/m2,&#xD;
      anticoagulation therapy and previous hypersensitivity to any of the study drugs were excluded&#xD;
      from the study.&#xD;
&#xD;
      They were equally randomly assigned to receive either remifentanil or esmolol to maintain&#xD;
      mean arterial blood pressure (MAP) between 55-65 mmHg.&#xD;
&#xD;
      After insertion of a peripheral venous cannula upon arrival to the operating room, balanced&#xD;
      electrolyte solution at 5 ml/kg/h was initiated. Following the premedication with intravenous&#xD;
      midazolam 0.05 miligram/kg IV 15 min prior to the induction of anesthesia, and standard&#xD;
      monitoring was applied consisting of electrocardiography (EKG), noninvasive blood pressure,&#xD;
      peripheral oxygen saturation (SPO2). Further, cerebral oxygen saturation value (rSO2, using&#xD;
      the NIRS with adult probe placed in the median frontal region) was continuously monitored&#xD;
      using NIRS before the induction of anesthesia.&#xD;
&#xD;
      After preoxygenation anaesthesia was induced with 2 miligram/kg propofol, 2 μg/kg fentanyl&#xD;
      and to facilitate the endotracheal intubation 0.6 miligram/kg rocuronium was administered.&#xD;
      Following orotracheal intubation, mechanical ventilation was adjusted to maintain PaCO2 at 35&#xD;
      to 40 mm Hg.&#xD;
&#xD;
      Anaesthesia maintenance was performed using sevoflurane (0.8 to 1 adjusted MAC) in a mixture&#xD;
      of O2/Nitrous oxide 50%/50%. Then the treatment protocol consisting of remifentanil and&#xD;
      esmolol were delivered in order to induce controlled hypotension that was considered&#xD;
      effective when MAP reached the target pressure of 60 mmHg.&#xD;
&#xD;
      Patients in the esmolol group (Group E) received esmolol 0.5 miligram/kg iv at induction&#xD;
      followed by a continuous infusion of esmolol 5-15 miligram/kg/min and titrated to the maximum&#xD;
      dose 300μg/kg/min to reach target MAP of 50-60 mmHg about a value of 5 mmHg. Patients in the&#xD;
      remifentanil group (Group R) received remifentanil 0.5 μg/kg/min at induction followed by an&#xD;
      infusion of remifentanil 0.1- 0.5 μg/kg/min and titrated between 0,1- 0,5 μg/kg/min to reach&#xD;
      target MAP of 50-60 mmHg about a value of 5 mmHg.&#xD;
&#xD;
      In both groups no surgical stress was applied during 5 min following start of hypotension.&#xD;
&#xD;
      Cerebral desaturation was defined as a reduction of rSO2 to higher than 20 % of baseline for&#xD;
      ≥ 15 seconds. When cerebral desaturation occurred, remifentanil and esmolol infusion doses&#xD;
      were decreased and MAP was increased with intravascular fluid administration and ephedrine.&#xD;
      When hypotension below the target MAP and bradycardia below the heart rate 45 beats/min&#xD;
      longer than one minute in duration were occurred, a bolus of ephedrine 10 mg iv and atropine&#xD;
      0.1 miligram/kg iv applied, respectively.&#xD;
&#xD;
      All operations were performed by the same attending surgeon in order to ensure consistency in&#xD;
      the estimation of the surgical field who was blinded to the hypotensive agent. When MAP&#xD;
      reached the desired range (50-60 mmHg) and was maintained for at least 10 minutes, the&#xD;
      quality of the surgical field was defined in terms of blood loss and dryness using a 10 point&#xD;
      scale (0= no bleeding, virtually bloodless field; 10= uncontrolled bleeding).&#xD;
&#xD;
      The cognitive function of the patients was assessed using Mini Mental State Examination&#xD;
      (MMSE) test. Preoperative MMSE test was done at the premedication room 1 hour before surgery&#xD;
      and 120 minutes after the discontinuation of the drugs for each patient. A decrease in the&#xD;
      MMSE score ≥ 2 points from baseline was considered as an index of decline in cognitive&#xD;
      function.&#xD;
&#xD;
      Hemodynamics (Diastolic blood pressure (DBP), Mean blood pressure (MBP), systolic blood&#xD;
      pressure (SBP) and heart rate (HR), SPO2 and rSO2 were recorded preoperatively (baseline),&#xD;
      postinduction 5th min (after administration of hypotensive and anesthetic agent),&#xD;
      intraoperatively (10, 20, 30, 45, 60, 90 minutes), 5 and 10 minutes after stoppage of&#xD;
      hypotensive agents. Additionally, the duration of surgery, duration of anesthesia, the&#xD;
      consumption dose of hypotensive agents, desaturated and not desaturated patients among the&#xD;
      groups were also recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 1, 2016</start_date>
  <completion_date type="Actual">August 1, 2017</completion_date>
  <primary_completion_date type="Actual">July 1, 2017</primary_completion_date>
  <phase>Phase 4</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>Screening</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cerebral desaturation</measure>
    <time_frame>reduction of cerebral oxygen saturation to higher than 20 % of baseline for ≥ 15 seconds through surgery completion</time_frame>
    <description>reduction of cerebral oxygen saturation to higher than 20 % of baseline for ≥ 15 seconds were recorded when MAP reached the desired range (50-60 mmHg)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the quality of the surgical field</measure>
    <time_frame>When MAP reached the desired range (50-60 mmHg) and was maintained for at least 10 minutes</time_frame>
    <description>the quality of the surgical field was recorded in terms of blood loss and dryness using a 10 point scale (0= no bleeding, virtually bloodless field; 10= uncontrolled bleeding) When MAP reached the desired range (50-60 mmHg) and was maintained for at least 10 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial blood pressure</measure>
    <time_frame>arterial blood pressure at baseline, after induction, peroperative and 5 and 10 minutes after stoppage of hypotensive agents through surgery completion</time_frame>
    <description>Hemodynamic parameters as systolic, diastolic and mean arterial blood pressures were recorded preoperative, after induction, peroperative and 5 and 10 minutes after stoppage of hypotensive agents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Heart rate at baseline, after induction, peroperative and 5 and 10 minutes after stoppage of hypotensive agents through surgery completion</time_frame>
    <description>Hemodynamic parameters as heart rates were recorded preoperative, after induction, peroperative and 5 and 10 minutes after stoppage of hypotensive agents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SPO2 value</measure>
    <time_frame>SPO2 value at baseline, after induction, peroperative and 5 and 10 minutes after stoppage of hypotensive agents through surgery completion</time_frame>
    <description>Hemodynamic parameters as SPO2 values were recorded preoperative, after induction, peroperative and 5 and 10 minutes after stoppage of hypotensive agents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cognitive function of the patients</measure>
    <time_frame>cognitive function of the patients were assessed 1 hour before surgery and 120 minutes after the discontinuation of the drugs</time_frame>
    <description>The cognitive function of the patients was assessed using Mini Mental State Examination (MMSE) test was recorded 1 hour before surgery and 120 minutes after the discontinuation of the drugs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the duration of surgery</measure>
    <time_frame>duration of the surgery from the beginning of the surgery up to the end of the surgery</time_frame>
    <description>duration of the surgery was recorded from the beginning of the surgery to the end of the surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of anesthesia</measure>
    <time_frame>Intraoperative</time_frame>
    <description>duration of anesthesia was recorded from the monitoring of the patient to the extubation of the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the consumption dose of hypotensive agents</measure>
    <time_frame>Intraoperative</time_frame>
    <description>the consumption dose of hypotensive agents were recorded from the from the beginning of the infusion to the stoppage of the drugs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>desaturated and not desaturated patients among the groups</measure>
    <time_frame>Intraoperative</time_frame>
    <description>desaturated and not desaturated patients were recorded patients among the groups during the controlled hypotension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cerebral oxygen saturation</measure>
    <time_frame>Intraoperative</time_frame>
    <description>cerebral oxygen saturation was recorded when mean arterial pressure reached the target range (50-60 mmHg)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Hypotension Drug-Induced</condition>
  <condition>Cerebral Oxygen Saturation</condition>
  <arm_group>
    <arm_group_label>b group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>b group controlled hypotension with esmolol hydrochloride</description>
  </arm_group>
  <arm_group>
    <arm_group_label>r group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>r group controlled hypotension with remifentanil hydrochloride</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Esmolol Hydrochloride</intervention_name>
    <description>the influence of brevibloc as a hypotensive agent on rSO2</description>
    <arm_group_label>b group</arm_group_label>
    <other_name>Brevibloc 10 MG/ML Injectable Solution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remifentanil Hydrochloride</intervention_name>
    <description>the influence of remifentanyl as a hypotensive agent on rSO2</description>
    <arm_group_label>r group</arm_group_label>
    <other_name>ultiva</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) I and II patients&#xD;
&#xD;
          -  aging between 18 and 65,&#xD;
&#xD;
          -  undergoing for elective FESS&#xD;
&#xD;
          -  requiring general anesthesia with endotracheal intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hypertension,&#xD;
&#xD;
          -  coronary artery diseases and cerebral insufficiency,&#xD;
&#xD;
          -  severe hypovolemia and anemia,&#xD;
&#xD;
          -  body mass index over 30 kg/m2,&#xD;
&#xD;
          -  anticoagulation therapy&#xD;
&#xD;
          -  previous hypersensitivity to any of the study drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Demet Altun</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul University, Department of Anesthesiology</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Demet Altun</investigator_full_name>
    <investigator_title>attending anesthesiologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remifentanil</mesh_term>
    <mesh_term>Esmolol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02967029
org study id: IstanbulUn
nct id: NCT02967029
lead sponsor: 
has dmc: No
For a successful functional endoscopic sinus surgery (FESS), it is crucial to provide
      effective controlled hypotension to reduce blood loss and provide a relatively blood-free
      surgical environment to facilitate surgery.

      The goal of controlled hypotension is to maintain an arterial blood pressure which is
      sufficiently low to allow a reduction in bleeding with offering a superior intraoperative
      hemodynamic stability during stressful surgical events to maintain intact cerebral
      microcirculatory auto-regulation.

      Auto-regulation impairment during controlled hypotension might increase oxygen extraction
      ratio. Thus monitoring the cerebral oxygen saturation (rSO2) to measure cerebral oxygenation
      becomes essential and it remains a challenge to clinically assess cerebral oxygenation on a
      routine basis.

      Various recent studies reported based on facilitating the induction of controlled
      hypotension, but the effects of hypotension on cerebral perfusion and oxygenation and its
      effects on postoperative cognitive function are still poorly characterized. Moreover, the
      relationship between rSO2 and controlled hypotension has not been established in patients
      undergoing FESS.

      Within the last decade, near infrared spectroscopy (NIRS) INVOS® monitors which is clinically
      most broadly spread technique, can be used for non-invasive assessment of cerebral perfusion
      by detecting changes in rSO2 by online monitoring of cerebral oxygenation.

      In our clinical routine for achieving a controlled hypotension, esmolol and remifentanyl are
      the most commonly used hypotensive agents. The aim of this prospective randomized single
      blind study was to investigate the influence of remifentanyl as a hypotensive agent in
      comparison to esmolol on rSO2 by using NIRS and postoperative cognitive function in patients
      undergoing FESS.
For a successful functional endoscopic sinus surgery (FESS), it is crucial to provide
      effective controlled hypotension to reduce blood loss and provide a relatively blood-free
      surgical environment to facilitate surgery.

      The goal of controlled hypotension is to maintain an arterial blood pressure which is
      sufficiently low to allow a reduction in bleeding with offering a superior intraoperative
      hemodynamic stability during stressful surgical events to maintain intact cerebral
      microcirculatory auto-regulation.

      Auto-regulation impairment during controlled hypotension might increase oxygen extraction
      ratio. Thus monitoring the cerebral oxygen saturation (rSO2) to measure cerebral oxygenation
      becomes essential and it remains a challenge to clinically assess cerebral oxygenation on a
      routine basis.

      Various recent studies reported based on facilitating the induction of controlled
      hypotension, but the effects of hypotension on cerebral perfusion and oxygenation and its
      effects on postoperative cognitive function are still poorly characterized. Moreover, the
      relationship between rSO2 and controlled hypotension has not been established in patients
      undergoing FESS.

      Within the last decade, near infrared spectroscopy (NIRS) monitors which is clinically most
      broadly spread technique, can be used for non-invasive assessment of cerebral perfusion by
      detecting changes in rSO2 by online monitoring of cerebral oxygenation.

      In our clinical routine for achieving a controlled hypotension, esmolol and remifentanyl are
      the most commonly used hypotensive agents. The aim of this prospective randomized single
      blind study was to investigate the influence of remifentanyl as a hypotensive agent in
      comparison to esmolol on rSO2 by using NIRS and postoperative cognitive function in patients
      undergoing FESS.

      After receiving the local institutional research ethics committee approval and written
      informed consent from each patient, 140 American Society of Anesthesiology (ASA) I and II
      patients aging between 18 and 65, undergoing for elective FESS and required controlled
      hypotension were enrolled in this study. Patients with hypertension, coronary artery diseases
      and cerebral insufficiency, severe hypovolemia and anemia, body mass index over 30 kg/m2,
      anticoagulation therapy and previous hypersensitivity to any of the study drugs were excluded
      from the study.

      They were equally randomly assigned to receive either remifentanil or esmolol to maintain
      mean arterial blood pressure (MAP) between 55-65 mmHg.

      After insertion of a peripheral venous cannula upon arrival to the operating room, balanced
      electrolyte solution at 5 ml/kg/h was initiated. Following the premedication with intravenous
      midazolam 0.05 miligram/kg IV 15 min prior to the induction of anesthesia, and standard
      monitoring was applied consisting of electrocardiography (EKG), noninvasive blood pressure,
      peripheral oxygen saturation (SPO2). Further, cerebral oxygen saturation value (rSO2, using
      the NIRS with adult probe placed in the median frontal region) was continuously monitored
      using NIRS before the induction of anesthesia.

      After preoxygenation anaesthesia was induced with 2 miligram/kg propofol, 2 μg/kg fentanyl
      and to facilitate the endotracheal intubation 0.6 miligram/kg rocuronium was administered.
      Following orotracheal intubation, mechanical ventilation was adjusted to maintain PaCO2 at 35
      to 40 mm Hg.

      Anaesthesia maintenance was performed using sevoflurane (0.8 to 1 adjusted MAC) in a mixture
      of O2/Nitrous oxide 50%/50%. Then the treatment protocol consisting of remifentanil and
      esmolol were delivered in order to induce controlled hypotension that was considered
      effective when MAP reached the target pressure of 60 mmHg.

      Patients in the esmolol group (Group E) received esmolol 0.5 miligram/kg iv at induction
      followed by a continuous infusion of esmolol 5-15 miligram/kg/min and titrated to the maximum
      dose 300μg/kg/min to reach target MAP of 50-60 mmHg about a value of 5 mmHg. Patients in the
      remifentanil group (Group R) received remifentanil 0.5 μg/kg/min at induction followed by an
      infusion of remifentanil 0.1- 0.5 μg/kg/min and titrated between 0,1- 0,5 μg/kg/min to reach
      target MAP of 50-60 mmHg about a value of 5 mmHg.

      In both groups no surgical stress was applied during 5 min following start of hypotension.

      Cerebral desaturation was defined as a reduction of rSO2 to higher than 20 % of baseline for
      ≥ 15 seconds. When cerebral desaturation occurred, remifentanil and esmolol infusion doses
      were decreased and MAP was increased with intravascular fluid administration and ephedrine.
      When hypotension below the target MAP and bradycardia below the heart rate 45 beats/min
      longer than one minute in duration were occurred, a bolus of ephedrine 10 mg iv and atropine
      0.1 miligram/kg iv applied, respectively.

      All operations were performed by the same attending surgeon in order to ensure consistency in
      the estimation of the surgical field who was blinded to the hypotensive agent. When MAP
      reached the desired range (50-60 mmHg) and was maintained for at least 10 minutes, the
      quality of the surgical field was defined in terms of blood loss and dryness using a 10 point
      scale (0= no bleeding, virtually bloodless field; 10= uncontrolled bleeding).

      The cognitive function of the patients was assessed using Mini Mental State Examination
      (MMSE) test. Preoperative MMSE test was done at the premedication room 1 hour before surgery
      and 120 minutes after the discontinuation of the drugs for each patient. A decrease in the
      MMSE score ≥ 2 points from baseline was considered as an index of decline in cognitive
      function.

      Hemodynamics (Diastolic blood pressure (DBP), Mean blood pressure (MBP), systolic blood
      pressure (SBP) and heart rate (HR), SPO2 and rSO2 were recorded preoperatively (baseline),
      postinduction 5th min (after administration of hypotensive and anesthetic agent),
      intraoperatively (10, 20, 30, 45, 60, 90 minutes), 5 and 10 minutes after stoppage of
      hypotensive agents. Additionally, the duration of surgery, duration of anesthesia, the
      consumption dose of hypotensive agents, desaturated and not desaturated patients among the
      groups were also recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Participant)
measure: cerebral desaturation
time frame: reduction of cerebral oxygen saturation to higher than 20 % of baseline for ≥ 15 seconds through surgery completion
description: reduction of cerebral oxygen saturation to higher than 20 % of baseline for ≥ 15 seconds were recorded when MAP reached the desired range (50-60 mmHg)
measure: the quality of the surgical field
time frame: When MAP reached the desired range (50-60 mmHg) and was maintained for at least 10 minutes
description: the quality of the surgical field was recorded in terms of blood loss and dryness using a 10 point scale (0= no bleeding, virtually bloodless field; 10= uncontrolled bleeding) When MAP reached the desired range (50-60 mmHg) and was maintained for at least 10 minutes
measure: Arterial blood pressure
time frame: arterial blood pressure at baseline, after induction, peroperative and 5 and 10 minutes after stoppage of hypotensive agents through surgery completion
description: Hemodynamic parameters as systolic, diastolic and mean arterial blood pressures were recorded preoperative, after induction, peroperative and 5 and 10 minutes after stoppage of hypotensive agents
measure: Heart rate
time frame: Heart rate at baseline, after induction, peroperative and 5 and 10 minutes after stoppage of hypotensive agents through surgery completion
description: Hemodynamic parameters as heart rates were recorded preoperative, after induction, peroperative and 5 and 10 minutes after stoppage of hypotensive agents
measure: SPO2 value
time frame: SPO2 value at baseline, after induction, peroperative and 5 and 10 minutes after stoppage of hypotensive agents through surgery completion
description: Hemodynamic parameters as SPO2 values were recorded preoperative, after induction, peroperative and 5 and 10 minutes after stoppage of hypotensive agents
measure: cognitive function of the patients
time frame: cognitive function of the patients were assessed 1 hour before surgery and 120 minutes after the discontinuation of the drugs
description: The cognitive function of the patients was assessed using Mini Mental State Examination (MMSE) test was recorded 1 hour before surgery and 120 minutes after the discontinuation of the drugs
measure: the duration of surgery
time frame: duration of the surgery from the beginning of the surgery up to the end of the surgery
description: duration of the surgery was recorded from the beginning of the surgery to the end of the surgery
measure: duration of anesthesia
time frame: Intraoperative
description: duration of anesthesia was recorded from the monitoring of the patient to the extubation of the patient
measure: the consumption dose of hypotensive agents
time frame: Intraoperative
description: the consumption dose of hypotensive agents were recorded from the from the beginning of the infusion to the stoppage of the drugs
measure: desaturated and not desaturated patients among the groups
time frame: Intraoperative
description: desaturated and not desaturated patients were recorded patients among the groups during the controlled hypotension
measure: cerebral oxygen saturation
time frame: Intraoperative
description: cerebral oxygen saturation was recorded when mean arterial pressure reached the target range (50-60 mmHg)
arm group label: b group
arm group type: Active Comparator
description: b group controlled hypotension with esmolol hydrochloride
arm group label: r group
arm group type: Active Comparator
description: r group controlled hypotension with remifentanil hydrochloride
intervention type: Drug
intervention name: Esmolol Hydrochloride
description: the influence of brevibloc as a hypotensive agent on rSO2
arm group label: b group
other name: Brevibloc 10 MG/ML Injectable Solution
intervention type: Drug
intervention name: Remifentanil Hydrochloride
description: the influence of remifentanyl as a hypotensive agent on rSO2
arm group label: r group
other name: ultiva
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Demet Altun
role: Principal Investigator
affiliation: Istanbul University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Demet Altun
investigator title: attending anesthesiologist
mesh term: Hypotension
mesh term: Remifentanil
mesh term: Esmolol
sharing ipd: No