Impact Of Total Intravenous Anesthesia Following Cancer Surgery, TIVACS Study

Study Overview

Impact of Total Intravenous Anesthesia Following Cancer Surgery, TIVACS Study

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.

PRIMARY OBJECTIVE: I. To evaluate the impact of anesthetic agent on inflammation and immunosuppression among patients undergoing abdominal cancer surgery. SECONDARY OBJECTIVE: I. 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 2 years.

Pancreatic Adenocarcinoma

PROCEDURE: Anesthesia Procedure
DRUG: General Anesthesia Procedure
PROCEDURE: Resection

OSU-20306
NCI-2021-05849 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program))

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-07-28	Results First Submitted 2025-03-27	Last Update Submitted that met QC Criteria 2025-06-24
First Submitted that Met QC Criteria 2021-07-28	Results First Submitted that Met QC Criteria 2025-06-24	Last Update Posted (ACTUAL) 2025-07-10
First Posted (ACTUAL) 2021-08-05	Results First Posted 2025-07-10	Last Verified 2025-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm I (surgical resection with TIVA) Patients undergo surgical resection with TIVA.	PROCEDURE: Anesthesia Procedure Given TIVA PROCEDURE: Resection Undergo 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 PROCEDURE: Resection Undergo surgical resection

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm I (surgical resection with TIVA)

Patients undergo surgical resection with TIVA.

PROCEDURE: Anesthesia Procedure

Given TIVA

PROCEDURE: Resection

Undergo 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

PROCEDURE: Resection

Undergo surgical resection

Primary Outcome Measures	Measure Description	Time Frame
Impact of Anesthetic Agent on Inflammation and Immunosuppression	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.	Up to 2 years

Secondary Outcome Measures	Measure Description	Time Frame
Impact of Anesthetic Choice on Short-term Anesthetic and Surgical Outcomes	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.	Up to 2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Adults: ≥18 years old on the day of consent
Non-metastatic pancreatic adenocarcinoma
Able to provide consent
ECOG performance status of 0 or 1
Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test for the patient at the time of surgery.
Ability to understand and the willingness to sign a written informed consent document.

Previous identified allergy or hypersensitivity to any component of the study treatment
Allergies to eggs, egg products, soybeans, or soy products
Personal or first degree relative with a history of malignant hyperthermia
Has a known additional malignancy that is expected to require active treatment within two years, or is likely to be life-limiting in the opinion of the treating investigator. Superficial bladder cancer, non-melanoma skin cancers, or low-grade prostate cancer not requiring therapy would not exclude participation in this trial.
Uncontrolled intercurrent illness including, but not limited to: Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant or lactating females
Major surgery within 2 months before enrollment. Complete healing from major surgery must have occurred 1 month before enrollment. Complete healing from minor surgery (eg, simple excision, tooth extraction) must have occurred at least 7 days before enrollment. Subjects with clinically relevant complications from prior surgery are not eligible.

Patients who undergo reoperation during their initial hospitalization will be censored at the time of reoperation.
Prisoner status

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Aslam Ejaz, MD, Ohio State University Comprehensive Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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