xml: <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/NCT06024733</url>
    </required_header>
    <id_info>
      <org_study_id>525</org_study_id>
      <nct_id>NCT06024733</nct_id>
    </id_info>
    <brief_title>Intravenous Anesthesia by Targeted Controlled Infusion Versus Inhalational Anesthesia on the Surgical Stress Response</brief_title>
    <official_title>Effect of Total Intravenous Anesthesia by Targeted Controlled Infusion on Surgical Stress Response Compared to Inhalational Anesthesia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <has_dmc>No</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>
        This study aims to compare the effect of total Intravenous anesthesia Target-controlled&#xD;
        infusion (TIVA-TCI) with inhalational anesthesia on stress response.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Target-controlled infusion (TCI) techniques have been used to induce and maintain general&#xD;
        anesthesia or to provide computer-assisted personalized sedation. Target-controlled infusion&#xD;
        (TCI) systems are computer-assisted IV infusion pumps that use pharmacokinetic and&#xD;
        pharmacodynamic mathematical modeling to maintain a user-designated target concentration at&#xD;
        an effect site (typically the brain).&#xD;
  &#xD;
        The clinician enters a desired target concentration for an anesthetic or another agent. The&#xD;
        computer calculates the amount of the agent required to achieve the target concentration at&#xD;
        the effect site and directs an infusion pump to deliver the calculated boluses or infusions.&#xD;
        Therefore, TIVA-TCI allows a more stable hemodynamic profile during surgery, prevents&#xD;
        long-acting opioid-induced accumulation and allows rapid recovery from general anesthesia.&#xD;
  &#xD;
        Total intravenous anaesthesia (TIVA) regimen with Propofol is a useful anaesthetic technique,&#xD;
        effectively controlling responses to tracheal intubation and intense surgical stimulation,&#xD;
        while avoiding Inhalational anaesthetics and allowing rapid emergence from anaesthesia .&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2024</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>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The level of the stress response by serum level of insulin-like growth factors</measure>
      <time_frame>Intraoperative and 2hours after surgery</time_frame>
      <description>The serum level of insulin-like growth factors will be measured at preoperative, intraoperative after one hour of intubation, at the end of surgery and after extubation, and transfer to the intensive care unit.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The Intensity of pain</measure>
      <time_frame>24 hours after surgery</time_frame>
      <description>The intensity of pain at rest and during pain-provoking movements, deep breathing coughing, mobilization measured by visual analog scale (VAS) pain score immediately postoperative and then at 2, 4, 6,12, and 24 hours after surgery.&#xD;
  VAS is from zero to 10. 0: no pain. 10: The worst pain.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Total Intravenous Anesthesia</condition>
    <condition>Inhalational Anesthesia</condition>
    <condition>Surgical Stress Response</condition>
    <condition>Target-controlled Infusion</condition>
    <arm_group>
      <arm_group_label>Target Controlled Infusion</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patient's age and weight will be entered into the Target Controlled Infusion unit, enabling target propofol concentrations to be set and the infusion to be started. Target induction concentrations will be 4-6 mcg/ ml. and anesthesia will be maintained with Target Controlled Infusion propofol at 3 - 6 mcg/ml as effect site concentration to maintain BIS 40-60</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Target Controlled Infusion and maintenance by sevoflurane</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will be induced with intravenous propofol 1.5 mg/kg and fentanyl 1- 2 μg/kg. Tracheal intubation after adequate neuromuscular blockade with rocuronium 0.6 mg/kg will be performed. Anesthesia will be maintained with sevoflurane 2-2.2 % to maintain a target MAC value between 0.8 &amp; 1.0.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Target Controlled Infusion and lidocaine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patients will receive total intravenous anesthesia with propofol Target Controlled Infusion. At the induction of anesthesia, the patients will receive a bolus of lidocaine 1% 1.5 mg/kg and a continuous infusion of lidocaine 1% 2 mg/kg/h will be associated throughout the procedure and 1mg/kg/h for 24 h postoperative.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Target Controlled Infusion</intervention_name>
      <description>the patient's age and weight will be entered into the Target Controlled Infusion unit enabling target propofol concentrations to be set and the infusion to be started. Target induction concentrations will be 4-6 mcg/ ml. and anesthesia will be maintained with Target Controlled Infusion propofol at 3 - 6 mcg/ml as effect site concentration to maintain BIS 40-60.</description>
      <arm_group_label>Target Controlled Infusion</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Target Controlled Infusion and maintenance by sevoflurane</intervention_name>
      <description>patients will be induced with intravenous propofol 1.5 mg/kg and fentanyl 1- 2 μg/kg. Tracheal intubation will be performed after adequate neuromuscular blockade with rocuronium 0.6 mg/kg. Anesthesia will be maintained with sevoflurane 2-2.2 % to maintain a target MAC value between 0.8 &amp; 1.0.</description>
      <arm_group_label>Target Controlled Infusion and maintenance by sevoflurane</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Target Controlled Infusion and lidocaine</intervention_name>
      <description>patients will receive total intravenous anesthesia with propofol Target Controlled Infusion. At the induction of anesthesia, the patients will receive a bolus of lidocaine 1% 1.5 mg/kg and a continuous infusion of lidocaine 1% 2 mg/kg/h will be associated throughout the procedure and 1mg/kg/h for 24 h postoperative.</description>
      <arm_group_label>Target Controlled Infusion and lidocaine</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients subjected to lower abdominal cancer surgery.&#xD;
  &#xD;
            2. Patients of both sexes&#xD;
  &#xD;
            3. body mass index &lt; 35 kg/m2.&#xD;
  &#xD;
            4. Age from 18 to 60 years.&#xD;
  &#xD;
            5. ASA, I-III and NYHA, I-III.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with a history of severe cardiovascular or respiratory disease.&#xD;
  &#xD;
            2. Severe hepatic, renal, or neurological diseases.&#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_contact>
      <last_name>Noha A Galal, MD</last_name>
      <phone>00201091007572</phone>
      <email>nohaali153@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Assiut University</name>
        <address>
          <city>Assiut</city>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>Noha A Galal, MD</last_name>
        <phone>00201091007572</phone>
        <email>nohaali153@yahoo.com</email>
      </contact>
      <investigator>
        <last_name>Sahar A Mohamed, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ahmed H Othman, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Fatma A Diab, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Noha Ali Galal</investigator_full_name>
      <investigator_title>Assistant lecturer of Anesthesia, ICU and pain Relief South Egypt Cancer Institute- Assiut University</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lidocaine</mesh_term>
      <mesh_term>Sevoflurane</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The data will be available upon a reasonable request from the corresponding author after the end of study for one year.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>for one year after the end of study</ipd_time_frame>
      <ipd_access_criteria>The data will be available upon a reasonable request from the corresponding author</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024733
  org study id: 525
  nct id: NCT06024733
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to compare the effect of total Intravenous anesthesia Target-controlled
        infusion (TIVA-TCI) with inhalational anesthesia on stress response.
  Target-controlled infusion (TCI) techniques have been used to induce and maintain general
        anesthesia or to provide computer-assisted personalized sedation. Target-controlled infusion
        (TCI) systems are computer-assisted IV infusion pumps that use pharmacokinetic and
        pharmacodynamic mathematical modeling to maintain a user-designated target concentration at
        an effect site (typically the brain).
  
        The clinician enters a desired target concentration for an anesthetic or another agent. The
        computer calculates the amount of the agent required to achieve the target concentration at
        the effect site and directs an infusion pump to deliver the calculated boluses or infusions.
        Therefore, TIVA-TCI allows a more stable hemodynamic profile during surgery, prevents
        long-acting opioid-induced accumulation and allows rapid recovery from general anesthesia.
  
        Total intravenous anaesthesia (TIVA) regimen with Propofol is a useful anaesthetic technique,
        effectively controlling responses to tracheal intubation and intense surgical stimulation,
        while avoiding Inhalational anaesthetics and allowing rapid emergence from anaesthesia .
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: The level of the stress response by serum level of insulin-like growth factors
  time frame: Intraoperative and 2hours after surgery
  description: The serum level of insulin-like growth factors will be measured at preoperative, intraoperative after one hour of intubation, at the end of surgery and after extubation, and transfer to the intensive care unit.
  measure: The Intensity of pain
  time frame: 24 hours after surgery
  description: The intensity of pain at rest and during pain-provoking movements, deep breathing coughing, mobilization measured by visual analog scale (VAS) pain score immediately postoperative and then at 2, 4, 6,12, and 24 hours after surgery.
  VAS is from zero to 10. 0: no pain. 10: The worst pain.
  arm group label: Target Controlled Infusion
  arm group type: Experimental
  description: Patient's age and weight will be entered into the Target Controlled Infusion unit, enabling target propofol concentrations to be set and the infusion to be started. Target induction concentrations will be 4-6 mcg/ ml. and anesthesia will be maintained with Target Controlled Infusion propofol at 3 - 6 mcg/ml as effect site concentration to maintain BIS 40-60
  arm group label: Target Controlled Infusion and maintenance by sevoflurane
  arm group type: Experimental
  description: Patients will be induced with intravenous propofol 1.5 mg/kg and fentanyl 1- 2 μg/kg. Tracheal intubation after adequate neuromuscular blockade with rocuronium 0.6 mg/kg will be performed. Anesthesia will be maintained with sevoflurane 2-2.2 % to maintain a target MAC value between 0.8 & 1.0.
  arm group label: Target Controlled Infusion and lidocaine
  arm group type: Experimental
  description: patients will receive total intravenous anesthesia with propofol Target Controlled Infusion. At the induction of anesthesia, the patients will receive a bolus of lidocaine 1% 1.5 mg/kg and a continuous infusion of lidocaine 1% 2 mg/kg/h will be associated throughout the procedure and 1mg/kg/h for 24 h postoperative.
  intervention type: Drug
  intervention name: Target Controlled Infusion
  description: the patient's age and weight will be entered into the Target Controlled Infusion unit enabling target propofol concentrations to be set and the infusion to be started. Target induction concentrations will be 4-6 mcg/ ml. and anesthesia will be maintained with Target Controlled Infusion propofol at 3 - 6 mcg/ml as effect site concentration to maintain BIS 40-60.
  arm group label: Target Controlled Infusion
  intervention type: Drug
  intervention name: Target Controlled Infusion and maintenance by sevoflurane
  description: patients will be induced with intravenous propofol 1.5 mg/kg and fentanyl 1- 2 μg/kg. Tracheal intubation will be performed after adequate neuromuscular blockade with rocuronium 0.6 mg/kg. Anesthesia will be maintained with sevoflurane 2-2.2 % to maintain a target MAC value between 0.8 & 1.0.
  arm group label: Target Controlled Infusion and maintenance by sevoflurane
  intervention type: Drug
  intervention name: Target Controlled Infusion and lidocaine
  description: patients will receive total intravenous anesthesia with propofol Target Controlled Infusion. At the induction of anesthesia, the patients will receive a bolus of lidocaine 1% 1.5 mg/kg and a continuous infusion of lidocaine 1% 2 mg/kg/h will be associated throughout the procedure and 1mg/kg/h for 24 h postoperative.
  arm group label: Target Controlled Infusion and lidocaine
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Noha A Galal, MD
  phone: 00201091007572
  email: nohaali153@yahoo.com
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Noha Ali Galal
  investigator title: Assistant lecturer of Anesthesia, ICU and pain Relief South Egypt Cancer Institute- Assiut University
  mesh term: Lidocaine
  mesh term: Sevoflurane
  sharing ipd: Yes
  ipd description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: for one year after the end of study
  ipd access criteria: The data will be available upon a reasonable request from the corresponding author