<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/NCT04434651</url>
  </required_header>
  <id_info>
    <org_study_id>6180</org_study_id>
    <nct_id>NCT04434651</nct_id>
  </id_info>
  <brief_title>Effect of SPGB on ICP and Oxygenation of Cerebral Venous Outflow in Craniotomy for Cerebral Tumors.</brief_title>
  <official_title>Effect of Sphenopalatine Ganglion Block on Intracranial Pressure and Cerebral Venous Outflow Oxygenation During Craniotomy for Supratentorial Brain Tumors.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to investigate the effect of Sphenopalatine Ganglion Block on ICP and&#xD;
      arterio- jugular venous oxygen difference (AJVDO2) and jugular bulb oxygen saturation&#xD;
      (SjVO2). Throughout this study, the efficacy of Sphenopalatine Ganglion Block as scalp block&#xD;
      in craniotomy operation will be assessed, and the effect of SPGB on cerebral hemostasis&#xD;
      during craniotomy will be evaluated by monitoring of both ICP, AJVDO2 and SjVO2.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was performed in the Neurosurgical operating room and included 52 patients&#xD;
      allocated into two groups: the treatment group (block group) and the control group (non-block&#xD;
      group). 26 patients enrolled in block group and 26 patients in non-block group.&#xD;
&#xD;
      Intraoperative ICP monitoring by subdural ICP monitors will be done every 20 minutes in both&#xD;
      block and non- block groups until craniotomy has been occurred, then at the time of closure&#xD;
      of the dura . Arterio- jugular venous oxygen difference and Jugular venous bulb oxygen&#xD;
      saturation changes will be recorded every 20 minutes in block and non- block groups&#xD;
      throughout time of the surgery till closure of the dura.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Actual">February 15, 2021</completion_date>
  <primary_completion_date type="Actual">December 29, 2020</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>
    <intervention_model_description>This study will be performed in the Neurosurgical operating room and included 52 patients allocated into two groups: the treatment group (block group) and the control group (non-block group). 26 patients enrolled in block group and 26 patients in non-block group.&#xD;
Intraoperative ICP monitoring by subdural ICP monitors will be done every 20 minutes in both block and non- block group.&#xD;
Jugular venous bulb oxygen saturation changes will be recorded every 20 minutes in block and non- block.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intracranial Pressure</measure>
    <time_frame>Every 20 minutes until time of initial craniotomy, then again after the dura was sutured.</time_frame>
    <description>ICP changes checked by a subdural ICP monitor that positioned after the first burr hole at the opposite side of the tumor immediately after induction of anesthesia. ICP monitoring will be conducted every 20 minutes until time of initial craniotomy and at time of closure of the dura.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Jugular venous bulb oxygen saturation and cerebral arteriovenous oxygen content difference.</measure>
    <time_frame>Every 20 minutes throughout the operation period.</time_frame>
    <description>Jugular venous bulb oxygen saturation will be measured then AVDO2 will be calculated.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Cerebral Tumor</condition>
  <arm_group>
    <arm_group_label>Block group (A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>26 patients who will be subjected to a neurosurgical intervention for removal of supratentorial brain tumor. Supratentorial brain tumors with shift of the mid-line &lt;10 mm evaluated by CT scan [computerized tomography] . SPGB will be performed using 2 % lidocaine before induction of anesthesia.&#xD;
The anesthesia induced by IV anesthetics and maintained by Isoflurane. ICP, Jugular venous bulb oxygen saturation, and AVDO2 will be assessed every 20 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control sham group (B)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>26 patients who will be subjected to a neurosurgical intervention for removal of supratentorial brain tumor. Supratentorial brain tumors with shift of the mid-line &lt;10 mm evaluated by CT scan [computerized tomography] . SPGB will be performed using normal saline.The anesthesia induced by IV anesthetics and maintained by Isoflurane. ICP, Jugular venous bulb oxygen saturation, and AVDO2 will be assessed every 20 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SPGB</intervention_name>
    <description>Sphenopalatine Ganglion Block using 2% lidocaine in block group. Sphenopalatine Ganglion Block is performed by a hollow culture swab that is connected with a 21-gauge a syringe filled with three ml 2% lidocaine, inserted parallel to the floor of the nose until resistance is felt. The swab is at the posterior pharyngeal wall superior to the middle turbinate. The applicator was kept in the nostril for five to ten mins. The same procedure is done also in the second nostril SPGB using normal saline is performed in the control group</description>
    <arm_group_label>Block group (A)</arm_group_label>
    <arm_group_label>control sham group (B)</arm_group_label>
    <other_name>Sphenopalatine ganglion block</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who prepared for a neurosurgical intervention for elective supratentorial&#xD;
             tumor removal&#xD;
&#xD;
          -  ASA 1 and 2&#xD;
&#xD;
          -  Age above 18 years and below 65 years&#xD;
&#xD;
          -  Fully conscious patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cardiovascular and respiratory diseases&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patient refusal&#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>Naglaa Abdelhaleem, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Medicine, Zagazig University, Zagazig, Egypt.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine, Zagazig University</name>
      <address>
        <city>Zagazig</city>
        <zip>44519</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Kaye A, Kucera IJ, Heavner J, Gelb A, Anwar M, Duban M, Arif AS, Craen R, Chang CT, Trillo R, Hoffman M. The comparative effects of desflurane and isoflurane on lumbar cerebrospinal fluid pressure in patients undergoing craniotomy for supratentorial tumors. Anesth Analg. 2004 Apr;98(4):1127-1132. doi: 10.1213/01.ANE.0000105862.78906.3D. Erratum In: Anesth Analg. 2016 Mar;122(3):922. Kaye, Alan [corrected to Kaye, Alan David].</citation>
    <PMID>15041612</PMID>
  </reference>
  <reference>
    <citation>Feldman Z, Robertson CS. Monitoring of cerebral hemodynamics with jugular bulb catheters. Crit Care Clin. 1997 Jan;13(1):51-77. doi: 10.1016/s0749-0704(05)70296-7.</citation>
    <PMID>9012576</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>August 4, 2021</last_update_submitted>
  <last_update_submitted_qc>August 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>Naglaa Fathy Abdelhaleem Abdelhaleem</investigator_full_name>
    <investigator_title>Lecturer, Anesthesia and Surgical Intensive Care Department, Faculty of Medicine</investigator_title>
  </responsible_party>
  <keyword>SPGB</keyword>
  <keyword>ICP</keyword>
  <keyword>CBF</keyword>
  <keyword>AVDO2</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>it will be available after completion of study and publication</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_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>The data will be available 3 months after publication of study</ipd_time_frame>
    <ipd_access_criteria>By contacting the principal investigator</ipd_access_criteria>
    <ipd_url>https://register.clinicaltrials.gov/prs/app</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/NCT04434651
org study id: 6180
nct id: NCT04434651
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study aims to investigate the effect of Sphenopalatine Ganglion Block on ICP and
      arterio- jugular venous oxygen difference (AJVDO2) and jugular bulb oxygen saturation
      (SjVO2). Throughout this study, the efficacy of Sphenopalatine Ganglion Block as scalp block
      in craniotomy operation will be assessed, and the effect of SPGB on cerebral hemostasis
      during craniotomy will be evaluated by monitoring of both ICP, AJVDO2 and SjVO2.
This study was performed in the Neurosurgical operating room and included 52 patients
      allocated into two groups: the treatment group (block group) and the control group (non-block
      group). 26 patients enrolled in block group and 26 patients in non-block group.

      Intraoperative ICP monitoring by subdural ICP monitors will be done every 20 minutes in both
      block and non- block groups until craniotomy has been occurred, then at the time of closure
      of the dura . Arterio- jugular venous oxygen difference and Jugular venous bulb oxygen
      saturation changes will be recorded every 20 minutes in block and non- block groups
      throughout time of the surgery till closure of the dura.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study will be performed in the Neurosurgical operating room and included 52 patients allocated into two groups: the treatment group (block group) and the control group (non-block group). 26 patients enrolled in block group and 26 patients in non-block group.
Intraoperative ICP monitoring by subdural ICP monitors will be done every 20 minutes in both block and non- block group.
Jugular venous bulb oxygen saturation changes will be recorded every 20 minutes in block and non- block.
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Intracranial Pressure
time frame: Every 20 minutes until time of initial craniotomy, then again after the dura was sutured.
description: ICP changes checked by a subdural ICP monitor that positioned after the first burr hole at the opposite side of the tumor immediately after induction of anesthesia. ICP monitoring will be conducted every 20 minutes until time of initial craniotomy and at time of closure of the dura.
measure: Jugular venous bulb oxygen saturation and cerebral arteriovenous oxygen content difference.
time frame: Every 20 minutes throughout the operation period.
description: Jugular venous bulb oxygen saturation will be measured then AVDO2 will be calculated.
arm group label: Block group (A)
arm group type: Experimental
description: 26 patients who will be subjected to a neurosurgical intervention for removal of supratentorial brain tumor. Supratentorial brain tumors with shift of the mid-line <10 mm evaluated by CT scan [computerized tomography] . SPGB will be performed using 2 % lidocaine before induction of anesthesia.
The anesthesia induced by IV anesthetics and maintained by Isoflurane. ICP, Jugular venous bulb oxygen saturation, and AVDO2 will be assessed every 20 minutes.
arm group label: control sham group (B)
arm group type: Sham Comparator
description: 26 patients who will be subjected to a neurosurgical intervention for removal of supratentorial brain tumor. Supratentorial brain tumors with shift of the mid-line <10 mm evaluated by CT scan [computerized tomography] . SPGB will be performed using normal saline.The anesthesia induced by IV anesthetics and maintained by Isoflurane. ICP, Jugular venous bulb oxygen saturation, and AVDO2 will be assessed every 20 minutes
intervention type: Procedure
intervention name: SPGB
description: Sphenopalatine Ganglion Block using 2% lidocaine in block group. Sphenopalatine Ganglion Block is performed by a hollow culture swab that is connected with a 21-gauge a syringe filled with three ml 2% lidocaine, inserted parallel to the floor of the nose until resistance is felt. The swab is at the posterior pharyngeal wall superior to the middle turbinate. The applicator was kept in the nostril for five to ten mins. The same procedure is done also in the second nostril SPGB using normal saline is performed in the control group
arm group label: Block group (A)
arm group label: control sham group (B)
other name: Sphenopalatine ganglion block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Naglaa Abdelhaleem, MD
role: Principal Investigator
affiliation: Faculty of Medicine, Zagazig University, Zagazig, Egypt.
facility: 
country: Egypt
citation: Kaye A, Kucera IJ, Heavner J, Gelb A, Anwar M, Duban M, Arif AS, Craen R, Chang CT, Trillo R, Hoffman M. The comparative effects of desflurane and isoflurane on lumbar cerebrospinal fluid pressure in patients undergoing craniotomy for supratentorial tumors. Anesth Analg. 2004 Apr;98(4):1127-1132. doi: 10.1213/01.ANE.0000105862.78906.3D. Erratum In: Anesth Analg. 2016 Mar;122(3):922. Kaye, Alan [corrected to Kaye, Alan David].
PMID: 15041612
citation: Feldman Z, Robertson CS. Monitoring of cerebral hemodynamics with jugular bulb catheters. Crit Care Clin. 1997 Jan;13(1):51-77. doi: 10.1016/s0749-0704(05)70296-7.
PMID: 9012576
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: Naglaa Fathy Abdelhaleem Abdelhaleem
investigator title: Lecturer, Anesthesia and Surgical Intensive Care Department, Faculty of Medicine
sharing ipd: Yes
ipd description: it will be available after completion of study and publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: The data will be available 3 months after publication of study
ipd access criteria: By contacting the principal investigator
ipd url: https://register.clinicaltrials.gov/prs/app