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