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Impact of Total Intravenous Anesthesia Following Cancer Surgery, TIVACS Study

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04992507
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
39
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase II trials studies the impact of total intravenous anesthesia (TIVA) following cancer surgery. Surgery and the anesthesia delivered causes physiologic stress and trauma resulting in immune suppression. TIVA is an alternative method of general anesthesia that has several benefits over volatile inhalation agents such as reducing nausea, vomiting, and opioid consumption, and promotes earlier return of bowel function following surgery. In addition, TIVA is less immunosuppressive than inhalational agents and has been shown to decrease cancer cell proliferation, migration, and metastasis formation. Giving TIVA during cancer-directed abdominal surgery may decrease the immunosuppressive state in the peri-surgical period.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Anesthesia Procedure
  • Drug: General Anesthesia Procedure
  • Procedure: Resection
 Phase 2

Detailed Description

PRIMARY OBJECTIVE:
  1. To evaluate the impact of anesthetic agent on inflammation and immunosuppression among patients undergoing abdominal cancer surgery.
SECONDARY OBJECTIVE:
  1. To determine the impact of anesthetic choice on short-term anesthetic and surgical outcomes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo surgical resection with TIVA.

ARM II: Patients undergo surgical resection with inhaled volatile anesthetics.

After completion of study treatment, patients are followed up for up to 5 years.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Impact of Total Intravenous Anesthesia Following Cancer Surgery (TIVACS) Study
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (surgical resection with TIVA)

Patients undergo surgical resection with TIVA.

Procedure: Anesthesia Procedure
Given TIVA
Other Names:
  • Anesthesia

    • Procedure: Resection
    Undergo surgical resection
    Other Names:
  • Surgical Resection

    		•
    Active Comparator: Arm II (surgical resection with inhaled volatile anesthetics)

    Patients undergo surgical resection with inhaled volatile anesthetics.

    Drug: General Anesthesia Procedure
    Given inhaled volatile anesthetics
    Other Names:
  • General Anesthesia

    • Procedure: Resection
    Undergo surgical resection
    Other Names:
  • Surgical Resection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Impact of anesthetic agent on inflammation and immunosuppression [Up to 5 years]

      All data analysis will use Student's t-test, Chi2 test and multivariable regression analysis using linear mixed model. The incidence of these outcomes will also be associated with NET levels.

    Secondary Outcome Measures

    1. Impact of anesthetic choice on short-term anesthetic and surgical outcomes [Up to 5 years]

      All data analysis will use Student's t-test, Chi2 test and multivariable regression analysis using linear mixed model. The incidence of these outcomes will also be associated with NET levels.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adults: >= 18 years

    • Diagnosed with pancreatic adenocarcinoma

    • Presented for surgery between January 1, 2021 and December 31, 2023

    • Able to provide consent

    Exclusion Criteria:

    • Allergies to study anesthetic - intravenous Propofol, or a history of malignant hyperthermia to volatile inhaled anesthetics

    • Prisoner status

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University Comprehensive Cancer Center

    Investigators

    • Principal Investigator: Aslam Ejaz, MD, Ohio State University Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Aslam Ejaz, Principal Investigator, Ohio State University Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04992507
    Other Study ID Numbers:
    • OSU-20306
    • NCI-2021-05849
    First Posted:
    Aug 5, 2021
    Last Update Posted:
    Aug 5, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adenocarcinoma
    Anesthetics

    Study Results

    No Results Posted as of Aug 5, 2021