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/NCT06017141</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00149314</org_study_id>
      <secondary_id>NCI-2023-05587</secondary_id>
      <secondary_id>IIT-2022-VIVA</secondary_id>
      <secondary_id>STUDY00149314</secondary_id>
      <secondary_id>P30CA168524</secondary_id>
      <nct_id>NCT06017141</nct_id>
    </id_info>
    <brief_title>Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer, VIVA Study</brief_title>
    <official_title>VIVA: Volatile or IV Anesthesia for Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Kansas Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Cancer Institute (NCI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Kansas Medical Center</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 trial evaluates how inhalational anesthesia (drawn in through the lungs) and total&#xD;
        intravenous anesthesia (TIVA) (through a needle in a vein in the arm) change the body's&#xD;
        ability to recover from surgery or whether they impact the immune system immediately after&#xD;
        surgery in patients with colon cancer. It is unknown whether these types of anesthesia change&#xD;
        recovery from surgery or change the chances cancer comes back following surgery. This study&#xD;
        may help researchers learn how different types of anesthesia affect recovery from colon&#xD;
        cancer surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVE:&#xD;
  &#xD;
        I. To evaluate the differential impact of TIVA versus inhaled anesthesia on neutrophil&#xD;
        extracellular traps (NET) inflammation and immunosuppression among patients undergoing cancer&#xD;
        surgery.&#xD;
  &#xD;
        SECONDARY OBJECTIVES:&#xD;
  &#xD;
        I. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on&#xD;
        patient reported post-operative recovery:&#xD;
  &#xD;
        Ia. Overall, and domain-specific post-operative recovery (as measured by the Quality of&#xD;
        Recovery Score [QoR]-40) on the day of discharge and other post-operative timepoints; Ib.&#xD;
        Changes in overall and domain-specific post-operative recovery over time.&#xD;
  &#xD;
        II. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on&#xD;
        peri-operative clinical and anesthetic outcomes, as recorded in the electronic medical record&#xD;
        (EMR), including:&#xD;
  &#xD;
        IIa. Post-operative nausea and vomiting (from medical record); IIb. Post-operative pain&#xD;
        (measured on a 1-10 scale) (from medical record); IIc. Return of gastrointestinal (GI)&#xD;
        function (from medical record); IId. Post-operative cognitive impairment (from medical&#xD;
        record); IIe. 30 and 90 days post-operative complications; IIf. Disease-free survival (from&#xD;
        medical record); IIg. Overall survival (from medical record). III. To evaluate the&#xD;
        differential impact of TIVA versus inhaled total anesthesia choice on circulating levels of&#xD;
        inflammatory cytokines, immune cell populations, global inflammatory markers.&#xD;
  &#xD;
        IV. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on&#xD;
        levels of circulating tumor DNA (ctDNA) at multiple post-operative timepoints according to&#xD;
        standard of care practices of the University of Kansas Medical Center (KUMC) Division of&#xD;
        Medical Oncology GI oncology practice.&#xD;
  &#xD;
        V. Correlation of peri-operative clinical and anesthetic outcomes to neutrophil extracellular&#xD;
        traps (NET) levels, measures of immune suppression, ctDNA.&#xD;
  &#xD;
        OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
  &#xD;
        ARM I: Patients receive standard of care (SOC) sedation with sevoflurane via inhalation and&#xD;
        fentanyl intravenously (IV) on study prior to SOC surgery. Some patients may also receive&#xD;
        sedation with propofol IV prior to surgery. All patients also undergo blood sample collection&#xD;
        throughout the study and collection of tissue sample during surgery.&#xD;
  &#xD;
        ARM II: Patients receive SOC sedation with fentanyl IV and propofol IV on study prior to SOC&#xD;
        surgery. Patients also undergo blood sample collection throughout the study and collection of&#xD;
        tissue sample during surgery.&#xD;
  &#xD;
        After completion of study treatment, patients are followed up at 1 and 3 days, 3 and 6 weeks,&#xD;
        3 and 6 months, and then yearly for 5 years from SOC surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 22, 2023</start_date>
    <completion_date type="Anticipated">May 22, 2026</completion_date>
    <primary_completion_date type="Anticipated">May 22, 2025</primary_completion_date>
    <phase>Phase 2</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>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Patients and statisticians are blinded to the type of anesthesia.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Neutrophil extracellular traps (NET) formation</measure>
      <time_frame>Post-operative day (POD) 1 to POD 6 months</time_frame>
      <description>The Neutrophil extracellular traps (NET) formation will be assessed by DNA complexes in myeloperoxidase (MPO). MPO are enzymes that come from white blood cells. The level of these enzymes will be compared by study group using statistical models. The time you are under anesthesia, the amount of anesthesia you are given, the type of surgery you have are all variables that will be considered when evaluating the two types of anesthesia.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Early post-operative recovery</measure>
      <time_frame>Post-Operative Day 0 to post-operative discharge, approximately 2-4 days</time_frame>
      <description>The QoR-40 is a recovery-specific and patient-rated questionnaire that contains 40 items measuring five dimensions: the physical comfort (12 items), emotional state (nine items), physical independence (five items), psychological support (seven items) and pain (seven items). Recovery will be assessed starting at Post-Operative Day Zero until the time you are discharged from the hospital.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Global and post-operative recovery</measure>
      <time_frame>Post-Operative Day 0 to 6 months post-operatively</time_frame>
      <description>The QoR-40 is a recovery-specific and patient-rated questionnaire that contains 40 items measuring five dimensions: the physical comfort (12 items), emotional state (nine items), physical independence (five items), psychological support (seven items) and pain (seven items). Recovery will be assessed starting at Post-Operative Day Zero, Day One Post-Operative, Day Three Post Operative, Week Three Post-Operative, Week Six Post-Operative, Month Three Post-Operative, and Month Six Post-Operative.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-operative nausea scores</measure>
      <time_frame>Post-Operative Day 0 to post-operative discharge, approximately 2-4 days</time_frame>
      <description>The post operative nausea scores will be assessed using standardized nursing assessments captured in the patient's medical record. These scores will be evaluated starting at Post-Operative Day Zero until patient discharge from the hospital.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number and cumulative amount of doses of anti-emetics</measure>
      <time_frame>Post-Operative Day 0 to post-operative discharge, approximately 2-4 days</time_frame>
      <description>The number and amount of doses of antiemetics will be assessed in the patient's medical record starting at Post-Operative Day Zero until the time they are discharged from the hospital.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total hospital opioid use</measure>
      <time_frame>Post-Operative Day 0 to post-operative discharge, approximately 2-4 days</time_frame>
      <description>The patient's total opioid use will be assessed in the patient's medical record starting at Post-Operative Day Zero until the time they are discharged from the hospital.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-reported pain scores</measure>
      <time_frame>Post-Operative Day 0 to post-operative discharge, approximately 2-4 days</time_frame>
      <description>The patient's total opioid use will be assessed in the patient's medical record starting at Post-Operative Day Zero until the time they are discharged from the hospital.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of times a pro re nata (PRN) medication administered</measure>
      <time_frame>Post-Operative Day 0 to post-operative discharge, approximately 2-4 days</time_frame>
      <description>The number of times a patient is administered medication PRN (as needed) will be assessed in the patient's medical record starting at Post-Operative Day Zero until the time they are discharged from the hospital.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>First post-op day when participant tolerates a regular diet (at the discretion of the surgical team)</measure>
      <time_frame>Post-Operative Day 0 to post-operative discharge, approximately 2-4 days</time_frame>
      <description>The first day when the patient is able to tolerate a regular diet. This will occur between Post-Operative Day Zero and the time they are discharged from the hospital.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time from study entry and from surgery to disease recurrence, death, or loss to follow up</measure>
      <time_frame>Post-Operative Day 0 up to Five Years Post-Operation</time_frame>
      <description>The length of time the patient is on the study and the time from surgery to either the cancer returning, the patient passing away, or the loss contact with the patient starting at Post-Operative Day Zero through the duration on the study (up to five years) unless the patient's disease returns, they pass away, or the study team loses contact with them.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-operative complications</measure>
      <time_frame>Post-Operative Day 0 to Three Months Post-Operatively</time_frame>
      <description>Complications will be assessed via the patients' medical record, and the Clavien-Dindo classification system which includes the comprehensive complication index. The Clavien-Dindo classification system consists of complication index consists of the of the following grades: I, II, IIIa, IIIb, IVa, IVb, V. Post-operative complications will be assessed Post-Operative Day Zero, Week Three Post-Operative, Week Six Post-Operative, Month Three Post-Operative.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-operative immune suppression</measure>
      <time_frame>Post-Operative Day 1 to 6 months Post-Operatively</time_frame>
      <description>Will be assessed by the notes in the patients' medical records and the biomarkers collected in the research blood tests. Post-operative immune suppression will be evaluated Post-Operative Day Zero, Week Three Post-Operative, Week Six Post-Operative, Month Three Post-Operative, and Month Six Post-Operative.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Circulating tumor deoxyribonucleic acid (ctDNA)</measure>
      <time_frame>Post-Operative Day 0 up to 5 years</time_frame>
      <description>Will be assessed by blood tests using commercially available, FDA approved, assays according to the standard practices of the University of Kansas Cancer Center (KUMC) Division of Medical Oncology GI Oncology Group. Differences between groups will be compared using regression based and/or non-parametric analyses as appropriate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in gene expression</measure>
      <time_frame>Immediately post-operatively</time_frame>
      <description>RNA sequencing of resected tumors will be used to investigate differences in gene expression by anesthesia type.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Colon Adenocarcinoma</condition>
    <arm_group>
      <arm_group_label>Arm I (sevoflurane, fentanyl citrate, propofol)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients receive SOC sedation with sevoflurane via inhalation and fentanyl IV on study during to SOC surgery. All patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm II (fentanyl citrate, propofol)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients receive SOC sedation with fentanyl IV and propofol IV on study during to SOC surgery. Patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Biospecimen Collection</intervention_name>
      <description>Undergo blood and tissue sample collection</description>
      <arm_group_label>Arm I (sevoflurane, fentanyl citrate, propofol)</arm_group_label>
      <arm_group_label>Arm II (fentanyl citrate, propofol)</arm_group_label>
      <other_name>Biological Sample Collection</other_name>
      <other_name>Biospecimen Collected</other_name>
      <other_name>Specimen Collection</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Electronic Health Record Review</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Arm I (sevoflurane, fentanyl citrate, propofol)</arm_group_label>
      <arm_group_label>Arm II (fentanyl citrate, propofol)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Fentanyl Citrate</intervention_name>
      <description>Given via injection</description>
      <arm_group_label>Arm I (sevoflurane, fentanyl citrate, propofol)</arm_group_label>
      <arm_group_label>Arm II (fentanyl citrate, propofol)</arm_group_label>
      <other_name>Actiq</other_name>
      <other_name>Fentanyl</other_name>
      <other_name>Fentyl</other_name>
      <other_name>Oralet</other_name>
      <other_name>Sublimaze</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Propofol</intervention_name>
      <description>Given IV</description>
      <arm_group_label>Arm I (sevoflurane, fentanyl citrate, propofol)</arm_group_label>
      <arm_group_label>Arm II (fentanyl citrate, propofol)</arm_group_label>
      <other_name>Diprivan</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire Administration</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Arm I (sevoflurane, fentanyl citrate, propofol)</arm_group_label>
      <arm_group_label>Arm II (fentanyl citrate, propofol)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sevoflurane</intervention_name>
      <description>Given via inhalation</description>
      <arm_group_label>Arm I (sevoflurane, fentanyl citrate, propofol)</arm_group_label>
      <other_name>Ultane</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Surgical Procedure</intervention_name>
      <description>Undergo SOC surgery</description>
      <arm_group_label>Arm I (sevoflurane, fentanyl citrate, propofol)</arm_group_label>
      <arm_group_label>Arm II (fentanyl citrate, propofol)</arm_group_label>
      <other_name>Operation</other_name>
      <other_name>Surgery</other_name>
      <other_name>Surgery Type</other_name>
      <other_name>Surgery, NOS</other_name>
      <other_name>Surgical</other_name>
      <other_name>Surgical Intervention</other_name>
      <other_name>Surgical Interventions</other_name>
      <other_name>Surgical Procedures</other_name>
      <other_name>Type of Surgery</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ability of participant OR Legally Authorized Representative (LAR) to understand this&#xD;
               study, and participant or LAR willingness to sign a written informed consent&#xD;
  &#xD;
            -  Males and females age &gt;= 18 years on day of consent&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2&#xD;
  &#xD;
            -  Patients undergoing resection for biopsy proven colon adenocarcinoma&#xD;
  &#xD;
            -  Medically fit for colon resection&#xD;
  &#xD;
            -  Ability to complete required study questionnaires&#xD;
  &#xD;
            -  Stated willingness to comply with all study procedures and availability for the&#xD;
               duration of the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of rectal adenocarcinoma&#xD;
  &#xD;
            -  Simultaneously enrolled in any therapeutic clinical trial. Subsequent enrollment in an&#xD;
               adjuvant therapy clinical trial is not automatically prohibited by this trial. Trial&#xD;
               eligibility for subsequent studies will be determined by the VIVA principal&#xD;
               investigator (PI) and the PI of the other clinical trial in question&#xD;
  &#xD;
            -  Diagnosed with a psychiatric illness or is in a social situation that would limit&#xD;
               compliance with study requirements&#xD;
  &#xD;
            -  Active grade 3 (per the National Cancer Institute Common Terminology Criteria for&#xD;
               Adverse Events [NCI CTCAE] version 5.0) or higher viral, bacterial, or fungal&#xD;
               infection within 2 weeks prior to the first dose of study treatment&#xD;
  &#xD;
            -  Prisoner status&#xD;
  &#xD;
            -  Allergies to eggs, egg products, soybeans, or soy products (relative or absolute&#xD;
               contraindication to propofol)&#xD;
  &#xD;
            -  Personal or first degree relative with a history of malignant hyperthermia (absolute&#xD;
               contraindication to inhaled volatile anesthetics)&#xD;
  &#xD;
            -  Diagnosis of inflammatory bowel disease&#xD;
  &#xD;
            -  Planned multi-visceral resection (examples include: pelvic exenteration, combined&#xD;
               liver and colon resection)&#xD;
  &#xD;
            -  Patients undergoing resection for unresectable polyps, or incomplete polypectomies&#xD;
               without biopsy proven adenocarcinoma are excluded&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Luke V Selby</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Kansas</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of Kansas Cancer Center</name>
        <address>
          <city>Kansas City</city>
          <state>Kansas</state>
          <zip>66160</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Luke V. Selby</last_name>
        <phone>913-588-7750</phone>
        <email>lselby@kumc.edu</email>
      </contact>
      <investigator>
        <last_name>Luke V. Selby</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Kansas Medical Center</investigator_affiliation>
      <investigator_full_name>Luke Selby</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colonic Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fentanyl</mesh_term>
      <mesh_term>Propofol</mesh_term>
      <mesh_term>Sevoflurane</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06017141
  org study id: STUDY00149314
  secondary id: NCI-2023-05587
  secondary id: IIT-2022-VIVA
  secondary id: STUDY00149314
  secondary id: P30CA168524
  nct id: NCT06017141
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This trial evaluates how inhalational anesthesia (drawn in through the lungs) and total
        intravenous anesthesia (TIVA) (through a needle in a vein in the arm) change the body's
        ability to recover from surgery or whether they impact the immune system immediately after
        surgery in patients with colon cancer. It is unknown whether these types of anesthesia change
        recovery from surgery or change the chances cancer comes back following surgery. This study
        may help researchers learn how different types of anesthesia affect recovery from colon
        cancer surgery.
  PRIMARY OBJECTIVE:
  
        I. To evaluate the differential impact of TIVA versus inhaled anesthesia on neutrophil
        extracellular traps (NET) inflammation and immunosuppression among patients undergoing cancer
        surgery.
  
        SECONDARY OBJECTIVES:
  
        I. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on
        patient reported post-operative recovery:
  
        Ia. Overall, and domain-specific post-operative recovery (as measured by the Quality of
        Recovery Score [QoR]-40) on the day of discharge and other post-operative timepoints; Ib.
        Changes in overall and domain-specific post-operative recovery over time.
  
        II. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on
        peri-operative clinical and anesthetic outcomes, as recorded in the electronic medical record
        (EMR), including:
  
        IIa. Post-operative nausea and vomiting (from medical record); IIb. Post-operative pain
        (measured on a 1-10 scale) (from medical record); IIc. Return of gastrointestinal (GI)
        function (from medical record); IId. Post-operative cognitive impairment (from medical
        record); IIe. 30 and 90 days post-operative complications; IIf. Disease-free survival (from
        medical record); IIg. Overall survival (from medical record). III. To evaluate the
        differential impact of TIVA versus inhaled total anesthesia choice on circulating levels of
        inflammatory cytokines, immune cell populations, global inflammatory markers.
  
        IV. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on
        levels of circulating tumor DNA (ctDNA) at multiple post-operative timepoints according to
        standard of care practices of the University of Kansas Medical Center (KUMC) Division of
        Medical Oncology GI oncology practice.
  
        V. Correlation of peri-operative clinical and anesthetic outcomes to neutrophil extracellular
        traps (NET) levels, measures of immune suppression, ctDNA.
  
        OUTLINE: Patients are randomized to 1 of 2 arms.
  
        ARM I: Patients receive standard of care (SOC) sedation with sevoflurane via inhalation and
        fentanyl intravenously (IV) on study prior to SOC surgery. Some patients may also receive
        sedation with propofol IV prior to surgery. All patients also undergo blood sample collection
        throughout the study and collection of tissue sample during surgery.
  
        ARM II: Patients receive SOC sedation with fentanyl IV and propofol IV on study prior to SOC
        surgery. Patients also undergo blood sample collection throughout the study and collection of
        tissue sample during surgery.
  
        After completion of study treatment, patients are followed up at 1 and 3 days, 3 and 6 weeks,
        3 and 6 months, and then yearly for 5 years from SOC surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: Patients and statisticians are blinded to the type of anesthesia.
  measure: Neutrophil extracellular traps (NET) formation
  time frame: Post-operative day (POD) 1 to POD 6 months
  description: The Neutrophil extracellular traps (NET) formation will be assessed by DNA complexes in myeloperoxidase (MPO). MPO are enzymes that come from white blood cells. The level of these enzymes will be compared by study group using statistical models. The time you are under anesthesia, the amount of anesthesia you are given, the type of surgery you have are all variables that will be considered when evaluating the two types of anesthesia.
  measure: Early post-operative recovery
  time frame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
  description: The QoR-40 is a recovery-specific and patient-rated questionnaire that contains 40 items measuring five dimensions: the physical comfort (12 items), emotional state (nine items), physical independence (five items), psychological support (seven items) and pain (seven items). Recovery will be assessed starting at Post-Operative Day Zero until the time you are discharged from the hospital.
  measure: Global and post-operative recovery
  time frame: Post-Operative Day 0 to 6 months post-operatively
  description: The QoR-40 is a recovery-specific and patient-rated questionnaire that contains 40 items measuring five dimensions: the physical comfort (12 items), emotional state (nine items), physical independence (five items), psychological support (seven items) and pain (seven items). Recovery will be assessed starting at Post-Operative Day Zero, Day One Post-Operative, Day Three Post Operative, Week Three Post-Operative, Week Six Post-Operative, Month Three Post-Operative, and Month Six Post-Operative.
  measure: Post-operative nausea scores
  time frame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
  description: The post operative nausea scores will be assessed using standardized nursing assessments captured in the patient's medical record. These scores will be evaluated starting at Post-Operative Day Zero until patient discharge from the hospital.
  measure: Number and cumulative amount of doses of anti-emetics
  time frame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
  description: The number and amount of doses of antiemetics will be assessed in the patient's medical record starting at Post-Operative Day Zero until the time they are discharged from the hospital.
  measure: Total hospital opioid use
  time frame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
  description: The patient's total opioid use will be assessed in the patient's medical record starting at Post-Operative Day Zero until the time they are discharged from the hospital.
  measure: Patient-reported pain scores
  time frame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
  description: The patient's total opioid use will be assessed in the patient's medical record starting at Post-Operative Day Zero until the time they are discharged from the hospital.
  measure: Number of times a pro re nata (PRN) medication administered
  time frame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
  description: The number of times a patient is administered medication PRN (as needed) will be assessed in the patient's medical record starting at Post-Operative Day Zero until the time they are discharged from the hospital.
  measure: First post-op day when participant tolerates a regular diet (at the discretion of the surgical team)
  time frame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
  description: The first day when the patient is able to tolerate a regular diet. This will occur between Post-Operative Day Zero and the time they are discharged from the hospital.
  measure: Time from study entry and from surgery to disease recurrence, death, or loss to follow up
  time frame: Post-Operative Day 0 up to Five Years Post-Operation
  description: The length of time the patient is on the study and the time from surgery to either the cancer returning, the patient passing away, or the loss contact with the patient starting at Post-Operative Day Zero through the duration on the study (up to five years) unless the patient's disease returns, they pass away, or the study team loses contact with them.
  measure: Post-operative complications
  time frame: Post-Operative Day 0 to Three Months Post-Operatively
  description: Complications will be assessed via the patients' medical record, and the Clavien-Dindo classification system which includes the comprehensive complication index. The Clavien-Dindo classification system consists of complication index consists of the of the following grades: I, II, IIIa, IIIb, IVa, IVb, V. Post-operative complications will be assessed Post-Operative Day Zero, Week Three Post-Operative, Week Six Post-Operative, Month Three Post-Operative.
  measure: Post-operative immune suppression
  time frame: Post-Operative Day 1 to 6 months Post-Operatively
  description: Will be assessed by the notes in the patients' medical records and the biomarkers collected in the research blood tests. Post-operative immune suppression will be evaluated Post-Operative Day Zero, Week Three Post-Operative, Week Six Post-Operative, Month Three Post-Operative, and Month Six Post-Operative.
  measure: Circulating tumor deoxyribonucleic acid (ctDNA)
  time frame: Post-Operative Day 0 up to 5 years
  description: Will be assessed by blood tests using commercially available, FDA approved, assays according to the standard practices of the University of Kansas Cancer Center (KUMC) Division of Medical Oncology GI Oncology Group. Differences between groups will be compared using regression based and/or non-parametric analyses as appropriate.
  measure: Changes in gene expression
  time frame: Immediately post-operatively
  description: RNA sequencing of resected tumors will be used to investigate differences in gene expression by anesthesia type.
  arm group label: Arm I (sevoflurane, fentanyl citrate, propofol)
  arm group type: Active Comparator
  description: Patients receive SOC sedation with sevoflurane via inhalation and fentanyl IV on study during to SOC surgery. All patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery.
  arm group label: Arm II (fentanyl citrate, propofol)
  arm group type: Experimental
  description: Patients receive SOC sedation with fentanyl IV and propofol IV on study during to SOC surgery. Patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery.
  intervention type: Procedure
  intervention name: Biospecimen Collection
  description: Undergo blood and tissue sample collection
  arm group label: Arm I (sevoflurane, fentanyl citrate, propofol)
  arm group label: Arm II (fentanyl citrate, propofol)
  other name: Biological Sample Collection
  other name: Biospecimen Collected
  other name: Specimen Collection
  intervention type: Other
  intervention name: Electronic Health Record Review
  description: Ancillary studies
  arm group label: Arm I (sevoflurane, fentanyl citrate, propofol)
  arm group label: Arm II (fentanyl citrate, propofol)
  intervention type: Drug
  intervention name: Fentanyl Citrate
  description: Given via injection
  arm group label: Arm I (sevoflurane, fentanyl citrate, propofol)
  arm group label: Arm II (fentanyl citrate, propofol)
  other name: Actiq
  other name: Fentanyl
  other name: Fentyl
  other name: Oralet
  other name: Sublimaze
  intervention type: Drug
  intervention name: Propofol
  description: Given IV
  arm group label: Arm I (sevoflurane, fentanyl citrate, propofol)
  arm group label: Arm II (fentanyl citrate, propofol)
  other name: Diprivan
  intervention type: Other
  intervention name: Questionnaire Administration
  description: Ancillary studies
  arm group label: Arm I (sevoflurane, fentanyl citrate, propofol)
  arm group label: Arm II (fentanyl citrate, propofol)
  intervention type: Drug
  intervention name: Sevoflurane
  description: Given via inhalation
  arm group label: Arm I (sevoflurane, fentanyl citrate, propofol)
  other name: Ultane
  intervention type: Procedure
  intervention name: Surgical Procedure
  description: Undergo SOC surgery
  arm group label: Arm I (sevoflurane, fentanyl citrate, propofol)
  arm group label: Arm II (fentanyl citrate, propofol)
  other name: Operation
  other name: Surgery
  other name: Surgery Type
  other name: Surgery, NOS
  other name: Surgical
  other name: Surgical Intervention
  other name: Surgical Interventions
  other name: Surgical Procedures
  other name: Type of Surgery
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Luke V Selby
  role: Principal Investigator
  affiliation: University of Kansas
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Kansas Medical Center
  investigator full name: Luke Selby
  investigator title: Principal Investigator
  mesh term: Colonic Neoplasms
  mesh term: Fentanyl
  mesh term: Propofol
  mesh term: Sevoflurane