<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/NCT03301025</url>
  </required_header>
  <id_info>
    <org_study_id>R/17.07.107</org_study_id>
    <nct_id>NCT03301025</nct_id>
  </id_info>
  <brief_title>Pregabalin Effects on Hypotensive Anesthesia During Spine Surgery.</brief_title>
  <official_title>Pregabalin Effects on Hypotensive Anesthesia During Spine Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</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>
      Elective lumbar spine surgical procedures are commonly performed under controlled hypotension&#xD;
      during general anesthesia. That is beneficial to limit the intraoperative blood loss and&#xD;
      transfusions and improves surgical field. Deliberate hypotension could be achieved via&#xD;
      various medications but mostly associated with significant side effects. Pregabalin&#xD;
      effectively augmented hypotensive anesthesia. The hypothesis is that Pregabalin 150 mg single&#xD;
      preoperative dose may augment intraoperative deliberate hypotension that will be reflected on&#xD;
      blood loss and nitroglycerin consumption.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An arterial line will be established then general anesthesia will be conducted. After&#xD;
      adequate preoxygenation, anesthesia induction by IV fentanyl 1.5µg/kg, propofol 2 mg/kg, and&#xD;
      atracurium 0.5 mg/kg then appropriated size tracheal tube. The ventilator settings will be&#xD;
      adjusted to maintain the end-tidal carbon dioxide tension (ETco2) at 30-35 mm Hg. Anesthesia&#xD;
      will be maintained by isoflurane concentration 1.2%, with 40% oxygen in air then IV infusion&#xD;
      of fentanyl 0.05 mcg/kg/min was started while atracurium 0.1 mg/kg incremental dose as&#xD;
      required. Then patients will be turned into the prone position above pad support permitting&#xD;
      free hanging of the abdomen. Intraoperatively, the target mean arterial arterial blood&#xD;
      pressure (MBP) is 55-65 mm Hg. After surgical incision, if MBP exceeds 65 mm Hg (defined as&#xD;
      hypertension) it will be managed by: increasing isoflurane MAC up to 2%, if no response after&#xD;
      5 min, Nitroglycerin infusion initiated at 0.5 mcg/kg/min to 40 mcg/kg/min. Hypotension (MBP&#xD;
      &lt;55 mm Hg) will be treated by stopping nitroglycerin, proper compensation of losses, reducing&#xD;
      Isoflurane MAC. If persisted; vasoactive drugs will be used. Bradycardia (HR &lt;50 beat/min.),&#xD;
      treated with 0.01 mg/kg atropine IV increments.&#xD;
&#xD;
      The nitroglycerin infusion will be stopped after the finial surgical hemostasis. Fentanyl&#xD;
      infusion will be stopped before ligament sutures. Isoflurane will be closed after the last&#xD;
      surgical suture. After dressing, patient will be turned to the supine position and morphine&#xD;
      0.025 mg/kg IV will be administered then 0.04 mg/kg neostigmine and 0.015 mg/kg atropine for&#xD;
      reversal. Extubation will be done after establishment of acceptable spontaneous respiration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2018</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 30, 2018</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nitroglycerin consumption</measure>
    <time_frame>Intraoperative</time_frame>
    <description>the total nitroglycerin consumption in milligram to maintain the target mean arterial pressure (MAP) 55- 65 mmHg.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimated blood loss</measure>
    <time_frame>intraoperative</time_frame>
    <description>towels are weighted, plus suction volume without irrigation fluids in milliter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of transfused blood unites</measure>
    <time_frame>intraoperative</time_frame>
    <description>Packed red blood cell unites</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate (HR)</measure>
    <time_frame>Basal, during intubation, then at 1, 5, 30, 60, 90, 120, 150, 180, 210 minutes post extubation, then postoperatively at 1 and 2 hours.</time_frame>
    <description>in beat/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>end-tidal isoflurane concentration</measure>
    <time_frame>at 30, 60, 90, 120, 150 , 180, 210 minutes after intubation.</time_frame>
    <description>in percent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgeon satisfaction about the field</measure>
    <time_frame>within 2 hours from the end of surgery.</time_frame>
    <description>using a six-point scale (0 = no bleeding, virtually bloodless field; 5 = uncontrolled) bleeding).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation</measure>
    <time_frame>at 0, 2, 4, 6, 12, 24 hours postoperatively</time_frame>
    <description>(Ramsay sedation scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time to the first request of analgesia.</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>in hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>at 0, 2, 4, 6, 12, 24 hours postoperatively.</time_frame>
    <description>(VAS 0-10 scale) 10 is the worst pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The total morphine consumption</measure>
    <time_frame>in the 1st 24 hours postoperatively</time_frame>
    <description>in mg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of adverse effects</measure>
    <time_frame>during the first 24 hours postoperatively</time_frame>
    <description>dizziness, headache, nausea and vomiting, or pruritus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak airway pressures</measure>
    <time_frame>10 minutes after settled prone position</time_frame>
    <description>in centimeter water</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>invasive mean arterial blood pressure (MAP)</measure>
    <time_frame>Basal, during intubation, then at 1, 5, 30, 60, 90, 120, 150, 180, 210 minutes post extubation, then postoperatively at 1 and 2 hours.</time_frame>
    <description>in millimeter mercury (mmHg)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Spine Surgery</condition>
  <arm_group>
    <arm_group_label>Pregabalin group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>(n=53):</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>(n=53):</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pregabalin</intervention_name>
    <description>Pregabalin 150 mg capsule, one h preinduction of general anesthesia</description>
    <arm_group_label>Pregabalin group</arm_group_label>
    <other_name>(LYRICA® 150 mg capsule- PFIZER)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>given a placebo identical capsule once one hour before anesthesia</description>
    <arm_group_label>placebo group</arm_group_label>
    <other_name>control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) score I-II&#xD;
&#xD;
          -  admitted to undergo lumbar discectomy or spinal fixation surgery under general&#xD;
             anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients on anti-hypertensive treatment, diuretics, corticosteroids, pregabalin,&#xD;
             gabapentin, anticonvulsants, antipsychotics,&#xD;
&#xD;
          -  alcohol addiction or drug abuse&#xD;
&#xD;
          -  patients with history of allergy to any drug used in the study .&#xD;
&#xD;
          -  pregnant or nursing women&#xD;
&#xD;
          -  patients with peripheral neuropathy, endocrinal diseases, bleeding abnormality,&#xD;
&#xD;
          -  cardiac, hepatic or renal impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alaa Mazy</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Medicine, Mansoura University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Delta Hospital</name>
      <address>
        <city>Mansourah,</city>
        <state>Dakahlia</state>
        <zip>35516</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mansoura University Hospital</name>
      <address>
        <city>Mansourah</city>
        <state>Dakahlia</state>
        <zip>35516</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>September 16, 2020</last_update_submitted>
  <last_update_submitted_qc>September 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Alaa Mazy Mazy</investigator_full_name>
    <investigator_title>Associate professor of anesthesia and surgical intensive care</investigator_title>
  </responsible_party>
  <keyword>Pregabalin, hypotensive anesthesia, blood loss, analgesia</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregabalin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>all data will be available after about 6 months</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Immediately following publication. No end date.</ipd_time_frame>
    <ipd_access_criteria>e mail: alaa_mazy@yahoo.com</ipd_access_criteria>
    <ipd_url>http://alaa_mazy@yahoo.com</ipd_url>
  </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/NCT03301025
org study id: R/17.07.107
nct id: NCT03301025
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Elective lumbar spine surgical procedures are commonly performed under controlled hypotension
      during general anesthesia. That is beneficial to limit the intraoperative blood loss and
      transfusions and improves surgical field. Deliberate hypotension could be achieved via
      various medications but mostly associated with significant side effects. Pregabalin
      effectively augmented hypotensive anesthesia. The hypothesis is that Pregabalin 150 mg single
      preoperative dose may augment intraoperative deliberate hypotension that will be reflected on
      blood loss and nitroglycerin consumption.
An arterial line will be established then general anesthesia will be conducted. After
      adequate preoxygenation, anesthesia induction by IV fentanyl 1.5µg/kg, propofol 2 mg/kg, and
      atracurium 0.5 mg/kg then appropriated size tracheal tube. The ventilator settings will be
      adjusted to maintain the end-tidal carbon dioxide tension (ETco2) at 30-35 mm Hg. Anesthesia
      will be maintained by isoflurane concentration 1.2%, with 40% oxygen in air then IV infusion
      of fentanyl 0.05 mcg/kg/min was started while atracurium 0.1 mg/kg incremental dose as
      required. Then patients will be turned into the prone position above pad support permitting
      free hanging of the abdomen. Intraoperatively, the target mean arterial arterial blood
      pressure (MBP) is 55-65 mm Hg. After surgical incision, if MBP exceeds 65 mm Hg (defined as
      hypertension) it will be managed by: increasing isoflurane MAC up to 2%, if no response after
      5 min, Nitroglycerin infusion initiated at 0.5 mcg/kg/min to 40 mcg/kg/min. Hypotension (MBP
      <55 mm Hg) will be treated by stopping nitroglycerin, proper compensation of losses, reducing
      Isoflurane MAC. If persisted; vasoactive drugs will be used. Bradycardia (HR <50 beat/min.),
      treated with 0.01 mg/kg atropine IV increments.

      The nitroglycerin infusion will be stopped after the finial surgical hemostasis. Fentanyl
      infusion will be stopped before ligament sutures. Isoflurane will be closed after the last
      surgical suture. After dressing, patient will be turned to the supine position and morphine
      0.025 mg/kg IV will be administered then 0.04 mg/kg neostigmine and 0.015 mg/kg atropine for
      reversal. Extubation will be done after establishment of acceptable spontaneous respiration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Nitroglycerin consumption
time frame: Intraoperative
description: the total nitroglycerin consumption in milligram to maintain the target mean arterial pressure (MAP) 55- 65 mmHg.
measure: Estimated blood loss
time frame: intraoperative
description: towels are weighted, plus suction volume without irrigation fluids in milliter.
measure: The number of transfused blood unites
time frame: intraoperative
description: Packed red blood cell unites
measure: heart rate (HR)
time frame: Basal, during intubation, then at 1, 5, 30, 60, 90, 120, 150, 180, 210 minutes post extubation, then postoperatively at 1 and 2 hours.
description: in beat/min
measure: end-tidal isoflurane concentration
time frame: at 30, 60, 90, 120, 150 , 180, 210 minutes after intubation.
description: in percent
measure: Surgeon satisfaction about the field
time frame: within 2 hours from the end of surgery.
description: using a six-point scale (0 = no bleeding, virtually bloodless field; 5 = uncontrolled) bleeding).
measure: Sedation
time frame: at 0, 2, 4, 6, 12, 24 hours postoperatively
description: (Ramsay sedation scale)
measure: The time to the first request of analgesia.
time frame: 24 hours postoperative
description: in hours
measure: Postoperative pain
time frame: at 0, 2, 4, 6, 12, 24 hours postoperatively.
description: (VAS 0-10 scale) 10 is the worst pain
measure: The total morphine consumption
time frame: in the 1st 24 hours postoperatively
description: in mg
measure: Frequency of adverse effects
time frame: during the first 24 hours postoperatively
description: dizziness, headache, nausea and vomiting, or pruritus.
measure: Peak airway pressures
time frame: 10 minutes after settled prone position
description: in centimeter water
measure: invasive mean arterial blood pressure (MAP)
time frame: Basal, during intubation, then at 1, 5, 30, 60, 90, 120, 150, 180, 210 minutes post extubation, then postoperatively at 1 and 2 hours.
description: in millimeter mercury (mmHg)
arm group label: Pregabalin group
arm group type: Active Comparator
description: (n=53):
arm group label: placebo group
arm group type: Placebo Comparator
description: (n=53):
intervention type: Drug
intervention name: Pregabalin
description: Pregabalin 150 mg capsule, one h preinduction of general anesthesia
arm group label: Pregabalin group
other name: (LYRICA® 150 mg capsule- PFIZER)
intervention type: Drug
intervention name: placebo
description: given a placebo identical capsule once one hour before anesthesia
arm group label: placebo group
other name: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Alaa Mazy
role: Principal Investigator
affiliation: Faculty of Medicine, Mansoura University
facility: 
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Alaa Mazy Mazy
investigator title: Associate professor of anesthesia and surgical intensive care
mesh term: Pregabalin
sharing ipd: Yes
ipd description: all data will be available after about 6 months
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Immediately following publication. No end date.
ipd access criteria: e mail: alaa_mazy@yahoo.com
ipd url: http://alaa_mazy@yahoo.com