<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/NCT04490122</url>
  </required_header>
  <id_info>
    <org_study_id>374</org_study_id>
    <nct_id>NCT04490122</nct_id>
  </id_info>
  <brief_title>Impact of Mode of Anesthesia on Ischemia Modified Albumin in Patients With Traumatic Brain Injury</brief_title>
  <official_title>Impact of Mode of Anesthesia on Ischemia Modified Albumin (Abiomarker of Oxidative Stress) and Outcome in Patients With Traumatic Brain Injury Undergoing Emergency Craniotomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abd-elrahman hassan abd -elaziz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Minia University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the current study the investigators intend to evaluate the mode of anesthesia on ischemia&#xD;
      modified albumin and outcome in patients with traumatic brain injury undergoing emergency&#xD;
      craniotomy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After obtaining Institutional Ethical Committee approval and written informed consent from&#xD;
      legally acceptable representative relatives, patients with traumatic brain injury, aged from&#xD;
      18- 60 years old, ASA from (I-III), GCS more than 8 undergoing emergency craniotomy surgery&#xD;
      will be selected for this prospective randomized Study.&#xD;
&#xD;
      The anesthesia will be induced with 2mcg/kg fentanyl and 2 mg/kg propofol. Muscle relaxation&#xD;
      will be achieved with 0.5 mg/kg atracurium.&#xD;
&#xD;
      Anesthesia will be maintained with:&#xD;
&#xD;
        -  Group I, isoflurane (mac&lt;1) mixed with oxygen 40% and fentanyl 1mcg/kg hourly.&#xD;
&#xD;
        -  Group PD, propofol infusion(100-150mcg/kg/min) and dexmedetomedine 0.3mcg/kg /h.&#xD;
&#xD;
      Parameters will be assessed Preoperative period&#xD;
&#xD;
        -  Ischemia modified albumin level from venous sample.&#xD;
&#xD;
        -  Basal Systolic blood pressure, diastolic blood pressure. Mean arterial blood pressure,&#xD;
           oxygen saturation, heart rate.&#xD;
&#xD;
        -  GCS. Intraoperative period&#xD;
&#xD;
        -  Systolic blood pressure, diastolic blood pressure. Mean arterial blood pressure, oxygen&#xD;
           saturation, heart rate after intubation, 5,15,30,60,90min and after extubation.&#xD;
&#xD;
        -  Need for resuscitation with vasoactive drugs.&#xD;
&#xD;
        -  Brain relaxation score at dural opening and closure.&#xD;
&#xD;
        -  ICP&#xD;
&#xD;
        -  Intraoperative blood loss.&#xD;
&#xD;
        -  Amount of fluid and blood transfusion. Postoperative period&#xD;
&#xD;
        -  Ischemia modified albumin immediately postoperatively, after 6h and after 24 hours.&#xD;
&#xD;
        -  Type of surgery.&#xD;
&#xD;
        -  Duration of surgery.&#xD;
&#xD;
        -  Extubation time.&#xD;
&#xD;
        -  Recovery scores (Ramsay sedation score and modified Alderte score).&#xD;
&#xD;
        -  GCS immediately postoperatively, after 6h, after 24h and after 48 hours.&#xD;
&#xD;
        -  Total analgesic requirement during the first 24 hours.&#xD;
&#xD;
        -  Need for ICU admission.&#xD;
&#xD;
        -  Length of ICU stay.&#xD;
&#xD;
        -  Complications.&#xD;
&#xD;
        -  28 day mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 23, 2020</start_date>
  <completion_date type="Anticipated">October 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 28, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ischemia modified albumin</measure>
    <time_frame>change from preoperative level of ischemia modified albumin at the first 24 hours postoperatively</time_frame>
    <description>Plasma Level of ischemia modified albumin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glascow Coma Scale</measure>
    <time_frame>change from preoperative Glascow Coma Scale score at the first 24 hours postoperatively</time_frame>
    <description>Glascow Coma Scale records the state of a person's consciousness. it gives a person's score between 3 (indicating deep unconsciousness) and 15 (indicating fully consciousness)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraoperative blood pressure.</measure>
    <time_frame>preoperatively, immediatly after intubation,after 5 minutes,afer 15 minutes,after 30 minutes,after 60 minutes,after 90 minutes and immediatly after extubation.</time_frame>
    <description>Intraoperative haemodynamics (Systolic blood pressure in millimeter mercury, diastolic blood pressure in millimeter mercury. Mean arterial blood pressure in millimeter mercury.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative heart rate</measure>
    <time_frame>preoperatively, immediatly after intubation,after 5 minutes,afer 15 minutes,after 30 minutes,after 60 minutes,after 90 minutes and immediatly after extubation.</time_frame>
    <description>Intraoperative heart rate per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>I.C.U admission</measure>
    <time_frame>up to 28 days</time_frame>
    <description>intensive care unit admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>I.C.U stay.</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Length of stay in intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of any complication.</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Incidence of any complication (nausea, vomiting, convulsion and reopening).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">54</enrollment>
  <condition>Oxidative Stress</condition>
  <arm_group>
    <arm_group_label>Inhalational</arm_group_label>
    <description>will receive inhalational anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Total intravenous</arm_group_label>
    <description>will receive total intravenous anesthesia with propofol infusion(100-150 mcg/kg/min) and dexmedetomedine 0.3mcg/kg/h.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        patients with traumatic brain injury, aged from 18- 60 years old, ASA from (I-III), GCS&#xD;
        more than 8 undergoing emergency craniotomy surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18-60 years old of both sex .&#xD;
&#xD;
          2. Isolated traumatic brain injury undergoing emergency craniotomy.&#xD;
&#xD;
          3. G.C.S more than 8.&#xD;
&#xD;
          4. ASA grade (I-III).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Non traumatic brain injury.&#xD;
&#xD;
          2. Poly trauma patient.&#xD;
&#xD;
          3. Coagulation disorder.&#xD;
&#xD;
          4. Drug( alcohol, opiods, tranquilizers) addiction.&#xD;
&#xD;
          5. Liver and kidney dysfunction.&#xD;
&#xD;
          6. Severe diseases such as severe hypertension, cardiovascular disease, malignant tumor,&#xD;
             autoimmune disease, mental disorders.&#xD;
&#xD;
          7. Diabetes mellitus with poor blood glucose control.&#xD;
&#xD;
          8. Previous drug allergy.&#xD;
&#xD;
          9. Currently lactating.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed K Mohamed, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Minia University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Abdel-rahman Abdel-aziz</last_name>
    <phone>01061812701</phone>
    <email>dr0abdohassan88@yahoo.com</email>
  </overall_contact>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4771225/</url>
    <description>Decompressive craniectomy and traumatic brain injury: a review.</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/31664468</url>
    <description>Comparison of total intravenous anesthesia vs. inhalational anesthesia on brain relaxation, intracranial pressure, and hemodynamics in patients with acute subdural hematoma undergoing emergency craniotomy: a randomized control trial</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/24527444</url>
    <description>The comparison of the effects of sevoflurane inhalation anesthesia and intravenous propofol anesthesia on oxidative stress in one lung ventilation.</description>
  </link>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>February 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Minia University</investigator_affiliation>
    <investigator_full_name>Abd-elrahman hassan abd -elaziz</investigator_full_name>
    <investigator_title>Minia University Hospital</investigator_title>
  </responsible_party>
  <keyword>Ischemia modified albumin</keyword>
  <keyword>oxidative stress</keyword>
  <keyword>traumatic brain injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_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/NCT04490122
org study id: 374
nct id: NCT04490122
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In the current study the investigators intend to evaluate the mode of anesthesia on ischemia
      modified albumin and outcome in patients with traumatic brain injury undergoing emergency
      craniotomy
After obtaining Institutional Ethical Committee approval and written informed consent from
      legally acceptable representative relatives, patients with traumatic brain injury, aged from
      18- 60 years old, ASA from (I-III), GCS more than 8 undergoing emergency craniotomy surgery
      will be selected for this prospective randomized Study.

      The anesthesia will be induced with 2mcg/kg fentanyl and 2 mg/kg propofol. Muscle relaxation
      will be achieved with 0.5 mg/kg atracurium.

      Anesthesia will be maintained with:

        -  Group I, isoflurane (mac<1) mixed with oxygen 40% and fentanyl 1mcg/kg hourly.

        -  Group PD, propofol infusion(100-150mcg/kg/min) and dexmedetomedine 0.3mcg/kg /h.

      Parameters will be assessed Preoperative period

        -  Ischemia modified albumin level from venous sample.

        -  Basal Systolic blood pressure, diastolic blood pressure. Mean arterial blood pressure,
           oxygen saturation, heart rate.

        -  GCS. Intraoperative period

        -  Systolic blood pressure, diastolic blood pressure. Mean arterial blood pressure, oxygen
           saturation, heart rate after intubation, 5,15,30,60,90min and after extubation.

        -  Need for resuscitation with vasoactive drugs.

        -  Brain relaxation score at dural opening and closure.

        -  ICP

        -  Intraoperative blood loss.

        -  Amount of fluid and blood transfusion. Postoperative period

        -  Ischemia modified albumin immediately postoperatively, after 6h and after 24 hours.

        -  Type of surgery.

        -  Duration of surgery.

        -  Extubation time.

        -  Recovery scores (Ramsay sedation score and modified Alderte score).

        -  GCS immediately postoperatively, after 6h, after 24h and after 48 hours.

        -  Total analgesic requirement during the first 24 hours.

        -  Need for ICU admission.

        -  Length of ICU stay.

        -  Complications.

        -  28 day mortality.
observational model: Cohort
time perspective: Prospective
measure: ischemia modified albumin
time frame: change from preoperative level of ischemia modified albumin at the first 24 hours postoperatively
description: Plasma Level of ischemia modified albumin
measure: Glascow Coma Scale
time frame: change from preoperative Glascow Coma Scale score at the first 24 hours postoperatively
description: Glascow Coma Scale records the state of a person's consciousness. it gives a person's score between 3 (indicating deep unconsciousness) and 15 (indicating fully consciousness)
measure: Intraoperative blood pressure.
time frame: preoperatively, immediatly after intubation,after 5 minutes,afer 15 minutes,after 30 minutes,after 60 minutes,after 90 minutes and immediatly after extubation.
description: Intraoperative haemodynamics (Systolic blood pressure in millimeter mercury, diastolic blood pressure in millimeter mercury. Mean arterial blood pressure in millimeter mercury.
measure: Intraoperative heart rate
time frame: preoperatively, immediatly after intubation,after 5 minutes,afer 15 minutes,after 30 minutes,after 60 minutes,after 90 minutes and immediatly after extubation.
description: Intraoperative heart rate per minute
measure: I.C.U admission
time frame: up to 28 days
description: intensive care unit admission
measure: I.C.U stay.
time frame: up to 28 days
description: Length of stay in intensive care unit
measure: Incidence of any complication.
time frame: up to 28 days
description: Incidence of any complication (nausea, vomiting, convulsion and reopening).
arm group label: Inhalational
description: will receive inhalational anesthesia
arm group label: Total intravenous
description: will receive total intravenous anesthesia with propofol infusion(100-150 mcg/kg/min) and dexmedetomedine 0.3mcg/kg/h.
serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ahmed K Mohamed, professor
role: Principal Investigator
affiliation: Minia University
last name: Abdel-rahman Abdel-aziz
phone: 01061812701
email: dr0abdohassan88@yahoo.com
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4771225/
description: Decompressive craniectomy and traumatic brain injury: a review.
url: https://www.ncbi.nlm.nih.gov/pubmed/31664468
description: Comparison of total intravenous anesthesia vs. inhalational anesthesia on brain relaxation, intracranial pressure, and hemodynamics in patients with acute subdural hematoma undergoing emergency craniotomy: a randomized control trial
url: https://www.ncbi.nlm.nih.gov/pubmed/24527444
description: The comparison of the effects of sevoflurane inhalation anesthesia and intravenous propofol anesthesia on oxidative stress in one lung ventilation.
responsible party type: Sponsor-Investigator
investigator affiliation: Minia University
investigator full name: Abd-elrahman hassan abd -elaziz
investigator title: Minia University Hospital
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Ischemia
sharing ipd: No