Impact of Total Intravenous Anesthesia following Cancer Surgery, TIVACS Study

Status: administratively complete

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.

Inclusion Criteria

Adults: >= 18 years
Non-metastatic pancreatic adenocarcinoma
Able to provide consent
Eastern Cooperative Oncology Group (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

Exclusion Criteria

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

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. Patients also undergo blood sample collection throughout study.

ARM II: Patients undergo surgical resection with inhaled volatile anesthetics. Patients also undergo blood sample collection throughout study.

After completion of study treatment, patients are followed up every 3 months for up to 2 years postoperatively.

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Impact of Total Intravenous Anesthesia following Cancer Surgery, TIVACS Study

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