Impact of Total Intravenous Anesthesia Following Cancer Surgery, TIVACS Study

NCT04992507 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: OSU-20306NCI-2021-05849
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Impact of Anesthetic Choice on Short-term Anesthetic and Surgical Outcomes

  Up to 2 years

Study Arms (2)

Arm I (surgical resection with TIVA)

EXPERIMENTAL

Patients undergo surgical resection with TIVA.

Procedure: Anesthesia Procedure; Procedure: Resection

Arm II (surgical resection with inhaled volatile anesthetics)

ACTIVE COMPARATOR

Patients undergo surgical resection with inhaled volatile anesthetics.

Drug: General Anesthesia Procedure; Procedure: Resection

Interventions

Anesthesia Procedure PROCEDURE

Given TIVA

Also known as: Anesthesia

Arm I (surgical resection with TIVA)

General Anesthesia Procedure DRUG

Given inhaled volatile anesthetics

Also known as: General Anesthesia

Arm II (surgical resection with inhaled volatile anesthetics)

Resection PROCEDURE

Undergo surgical resection

Also known as: Surgical Resection

Arm I (surgical resection with TIVA); Arm II (surgical resection with inhaled volatile anesthetics)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Interventions

Anesthesia; Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Results Point of Contact

• Title: Dr. Aslam Ejaz
• Organization: The Ohio State University Comprehensive Cancer Center

aejaz@uic.edu

614-293-7171

Study Officials

• Aslam Ejaz, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 5, 2021
• Study Start: June 2, 2023
• Primary Completion: January 26, 2024
• Study Completion: January 26, 2024
• Last Updated: July 10, 2025
• Results First Posted: July 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)