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TerminatedPhase 2

Impact of Total Intravenous Anesthesia Following Cancer Surgery, TIVACS Study

Key facts

Who runs it
Ohio State University Comprehensive Cancer Center
Where
Columbus, United StatesSee the site
Trial code
Status
Terminated
Phase
Phase 2
People taking part
8 people enrolled
Started
2 Jun 2023
Ended
26 Jan 2024
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Anesthesia Procedure
  • General Anesthesia Procedure
  • Resection
Record updated
10 July 2025
Why it stopped
Principal investigator departed sponsoring organization

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Previous identified allergy or hypersensitivity to any component of the study treatment
  • 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
  • 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
  • Prisoner status

Where in United States

  • Ohio State University Comprehensive Cancer CenterColumbus, United States

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Arm I (surgical resection with TIVA)Treatment being tested

    Patients undergo surgical resection with TIVA.

    Treatment: Anesthesia Procedure and Resection

  • Arm II (surgical resection with inhaled volatile anesthetics)Existing treatment, for comparison

    Patients undergo surgical resection with inhaled volatile anesthetics.

    Treatment: General Anesthesia Procedure and Resection

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Impact of Total Intravenous Anesthesia Following Cancer Surgery (TIVACS) Study
Record updated
10 July 2025