<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/NCT02987218</url>
  </required_header>
  <id_info>
    <org_study_id>INT/IEC/2015/741</org_study_id>
    <nct_id>NCT02987218</nct_id>
  </id_info>
  <brief_title>Comparison of Neuroprotection by Propofol and Desflurane for POCD Following Subarachnoid Hemorrhage Surgery</brief_title>
  <official_title>Comparison Of Pharmacological Neuroprotection Provided By PROPOFOL VERSUS DESFLURANE For Long Term Postoperative Cognitive Dysfunction In Patients Undergoing Surgery For Aneurysmal Subarachnoid Hemorrhage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Postgraduate Institute of Medical Education and Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Postgraduate Institute of Medical Education and Research</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aneurysmal subarachnoid hemorrhage (aSAH) is characterized by the rupture of an intracranial&#xD;
      aneurysm and accumulation of blood in the subarachnoid space with 30 to 40% mortality rate.&#xD;
      Amongst the survivors 40-50% suffers disability due to cognitive decline.Trends towards early&#xD;
      surgery offers challenge to anesthesiologist to provide optimum brain relaxation and&#xD;
      simultaneously maintaining stable hemodynamics. Anesthetic agents are administered to conduct&#xD;
      smooth neurosurgical procedure. These agents may affect patient's cognitive function&#xD;
      postoperatively.Currently most common anesthetic agents used are either intravenous hypnotic&#xD;
      agents (propofol) or volatile inhalational agents (isoflurane/sevoflurane/desflurane).&#xD;
      Provision of neuroprotection with propofol and volatile inhalational agents has been studied&#xD;
      by various authors.Not many studies have been performed in patients undergoing aneurysmal&#xD;
      clipping surgeries looking into effects of various anesthetic agents on intraoperative (I/O)&#xD;
      brain condition, I/O hemodynamic and POCD.Thus present study is planned to compare propofol&#xD;
      and desflurane for long term postoperative cognitive decline in patients undergoing surgery&#xD;
      following aneurysmal subarachnoid hemorrhage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      100 patients will be randomized into two groups, Desflurane group (Group D) and Propofol&#xD;
      group (Group P) using a computer generated algorithm. Written informed consent will be taken&#xD;
      from all the patients.&#xD;
&#xD;
      Cognition assessed using MOCA (Montreal Cognitive Assessment)test. A preoperative assessment&#xD;
      for establishing the patient's baseline performance. Surgery-related factors may affect test&#xD;
      performance if performed too early to reduce possibility of confounding factors, we planned&#xD;
      to conduct the test for POCD at the time of discharge of the patient after surgery. To&#xD;
      compare long term protection provided by anesthetic agent cognitive functions were assessed&#xD;
      at one month following surgery.&#xD;
&#xD;
      Cognitive functions will be assessed at following time period A) Preoperatively B)&#xD;
      Postoperatively B1- At the time of discharge B2- 1month after discharge following surgery.&#xD;
&#xD;
      Biomarker levels S100B levels were also measured A) Preoperatively B) Intraoperatively - post&#xD;
      clipping C) Postoperatively - 1hour after surgery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of cognitive function at one month following surgery.</measure>
    <time_frame>One month</time_frame>
    <description>Montreal Cognitive Assessment scale is used</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of cognitive function preoperatively Assessment of cognitive function at discharge. Comparison of biomarker of cognitive dysfunction</measure>
    <time_frame>Baseline cognition assessment prior to surgery</time_frame>
    <description>Montreal Cognitive Assessment scale used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of cognitive function preoperatively Assessment of cognitive function at the time of discharge from hospital</measure>
    <time_frame>Discharge from hospital</time_frame>
    <description>Montreal Cognitive Assessment scale used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of biomarker (S-100B) levels</measure>
    <time_frame>Prior to surgery , After clipping of aneurysm, One hour after completion of surgery</time_frame>
    <description>Blood sample for S100B levels used</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Postoperative Cognitive Function</condition>
  <arm_group>
    <arm_group_label>PROPOFOL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intravenous hypnotic agent Decrease Cerebral Metabolic reduction Decrease ICP(Intracranial pressure) Better cognitive Function preservation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DESFLURANE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Inhalational agent. Decreases cerebral metabolism Increase /decreases ICP Cognition preservation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Intravenous hypnotic agent Decrease Cerebral Metabolic reduction Decrease ICP Better cognitive Function preservation</description>
    <arm_group_label>PROPOFOL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Desflurane</intervention_name>
    <description>Inhalational agent. Decreases cerebral metabolism Increase /decreases ICP Cognition preservation</description>
    <arm_group_label>DESFLURANE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients scheduled for aneurysmal SAH surgery with clinical and radiological evidence&#xD;
             of cerebral aneurysm.&#xD;
&#xD;
          2. Age between 18 to 65 yrs.&#xD;
&#xD;
          3. World Federation of neurosurgery grade 1, 2.&#xD;
&#xD;
          4. American society of Anesthesia grade 1, 2 and 3.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Co-morbidities other than hypertension and diabetes mellitus like cardiovascular&#xD;
             disease and respiratory impairment.&#xD;
&#xD;
          2. Patients with known psychiatric disease.&#xD;
&#xD;
          3. History of drug abuse.&#xD;
&#xD;
          4. Low level of education (illiterate) or multiple failures in school.&#xD;
&#xD;
          5. Patients who are unconscious, intubated or tracheostomised even after two weeks&#xD;
             following exposure to anesthesia will also be excluded from the study.&#xD;
&#xD;
          6. Intraoperative complications like massive blood loss, prolonged clipping&#xD;
             time(&gt;20minutes), severe intraoperative brain swelling precluding replacement of bone&#xD;
             flap.&#xD;
&#xD;
          7. Patients with infectious diseases and respiratory complications.&#xD;
&#xD;
          8. Multiple surgeries.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shalvi Mahajan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Postgraduate Institute of Medical Education and Research</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hemant Bhagat, DM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Postgraduate Institute of Medical Education and Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Postgraduate institute of medical education and research</name>
      <address>
        <city>Chandigarh</city>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <results_reference>
    <citation>Wong GK, Lam S, Ngai K, Wong A, Mok V, Poon WS; Cognitive Dysfunction after Aneurysmal Subarachnoid Haemorrhage Investigators. Evaluation of cognitive impairment by the Montreal cognitive assessment in patients with aneurysmal subarachnoid haemorrhage: prevalence, risk factors and correlations with 3 month outcomes. J Neurol Neurosurg Psychiatry. 2012 Nov;83(11):1112-7. doi: 10.1136/jnnp-2012-302217. Epub 2012 Jul 31.</citation>
    <PMID>22851612</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Postgraduate Institute of Medical Education and Research</investigator_affiliation>
    <investigator_full_name>Dr Shalvi mahajan</investigator_full_name>
    <investigator_title>Senior Resident</investigator_title>
  </responsible_party>
  <keyword>POCD</keyword>
  <keyword>subarachnoid hemorrhage</keyword>
  <keyword>Propofol</keyword>
  <keyword>Desflurane</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Subarachnoid Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Desflurane</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT02987218
org study id: INT/IEC/2015/741
nct id: NCT02987218
lead sponsor: 
has dmc: Yes
Aneurysmal subarachnoid hemorrhage (aSAH) is characterized by the rupture of an intracranial
      aneurysm and accumulation of blood in the subarachnoid space with 30 to 40% mortality rate.
      Amongst the survivors 40-50% suffers disability due to cognitive decline.Trends towards early
      surgery offers challenge to anesthesiologist to provide optimum brain relaxation and
      simultaneously maintaining stable hemodynamics. Anesthetic agents are administered to conduct
      smooth neurosurgical procedure. These agents may affect patient's cognitive function
      postoperatively.Currently most common anesthetic agents used are either intravenous hypnotic
      agents (propofol) or volatile inhalational agents (isoflurane/sevoflurane/desflurane).
      Provision of neuroprotection with propofol and volatile inhalational agents has been studied
      by various authors.Not many studies have been performed in patients undergoing aneurysmal
      clipping surgeries looking into effects of various anesthetic agents on intraoperative (I/O)
      brain condition, I/O hemodynamic and POCD.Thus present study is planned to compare propofol
      and desflurane for long term postoperative cognitive decline in patients undergoing surgery
      following aneurysmal subarachnoid hemorrhage.
100 patients will be randomized into two groups, Desflurane group (Group D) and Propofol
      group (Group P) using a computer generated algorithm. Written informed consent will be taken
      from all the patients.

      Cognition assessed using MOCA (Montreal Cognitive Assessment)test. A preoperative assessment
      for establishing the patient's baseline performance. Surgery-related factors may affect test
      performance if performed too early to reduce possibility of confounding factors, we planned
      to conduct the test for POCD at the time of discharge of the patient after surgery. To
      compare long term protection provided by anesthetic agent cognitive functions were assessed
      at one month following surgery.

      Cognitive functions will be assessed at following time period A) Preoperatively B)
      Postoperatively B1- At the time of discharge B2- 1month after discharge following surgery.

      Biomarker levels S100B levels were also measured A) Preoperatively B) Intraoperatively - post
      clipping C) Postoperatively - 1hour after surgery
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Assessment of cognitive function at one month following surgery.
time frame: One month
description: Montreal Cognitive Assessment scale is used
measure: Assessment of cognitive function preoperatively Assessment of cognitive function at discharge. Comparison of biomarker of cognitive dysfunction
time frame: Baseline cognition assessment prior to surgery
description: Montreal Cognitive Assessment scale used
measure: Assessment of cognitive function preoperatively Assessment of cognitive function at the time of discharge from hospital
time frame: Discharge from hospital
description: Montreal Cognitive Assessment scale used
measure: Comparison of biomarker (S-100B) levels
time frame: Prior to surgery , After clipping of aneurysm, One hour after completion of surgery
description: Blood sample for S100B levels used
arm group label: PROPOFOL
arm group type: Active Comparator
description: Intravenous hypnotic agent Decrease Cerebral Metabolic reduction Decrease ICP(Intracranial pressure) Better cognitive Function preservation
arm group label: DESFLURANE
arm group type: Active Comparator
description: Inhalational agent. Decreases cerebral metabolism Increase /decreases ICP Cognition preservation
intervention type: Drug
intervention name: Propofol
description: Intravenous hypnotic agent Decrease Cerebral Metabolic reduction Decrease ICP Better cognitive Function preservation
arm group label: PROPOFOL
intervention type: Drug
intervention name: Desflurane
description: Inhalational agent. Decreases cerebral metabolism Increase /decreases ICP Cognition preservation
arm group label: DESFLURANE
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Shalvi Mahajan, MD
role: Principal Investigator
affiliation: Postgraduate Institute of Medical Education and Research
last name: Hemant Bhagat, DM
role: Principal Investigator
affiliation: Postgraduate Institute of Medical Education and Research
facility: 
country: India
citation: Wong GK, Lam S, Ngai K, Wong A, Mok V, Poon WS; Cognitive Dysfunction after Aneurysmal Subarachnoid Haemorrhage Investigators. Evaluation of cognitive impairment by the Montreal cognitive assessment in patients with aneurysmal subarachnoid haemorrhage: prevalence, risk factors and correlations with 3 month outcomes. J Neurol Neurosurg Psychiatry. 2012 Nov;83(11):1112-7. doi: 10.1136/jnnp-2012-302217. Epub 2012 Jul 31.
PMID: 22851612
responsible party type: Principal Investigator
investigator affiliation: Postgraduate Institute of Medical Education and Research
investigator full name: Dr Shalvi mahajan
investigator title: Senior Resident
mesh term: Subarachnoid Hemorrhage
mesh term: Hemorrhage
mesh term: Propofol
mesh term: Desflurane
sharing ipd: Yes