Impact of Total Intravenous Anesthesia Following Cancer Surgery, TIVACS Study

Phase 2

Completed

• Conditions: Pancreatic Adenocarcinoma
• Interventions: Procedure: Anesthesia Procedure; Drug: General Anesthesia Procedure; Procedure: Resection

• Registration Number: NCT04992507
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-05
• Study Start: 2023-06-02
• Primary Completion: 2024-01-26
• Study Completion: 2024-01-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• 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.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (surgical resection with TIVA)	Resection	Patients undergo surgical resection with TIVA.
Arm I (surgical resection with TIVA)	Anesthesia Procedure	Patients undergo surgical resection with TIVA.
Arm II (surgical resection with inhaled volatile anesthetics)	General Anesthesia Procedure	Patients undergo surgical resection with inhaled volatile anesthetics.
Arm II (surgical resection with inhaled volatile anesthetics)	Resection	Patients undergo surgical resection with inhaled volatile anesthetics.

Primary Outcome Measures

Name	Time	Method
Impact of anesthetic agent on inflammation and immunosuppression	Up to 2 years	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.

Secondary Outcome Measures

Name	Time	Method
Impact of anesthetic choice on short-term anesthetic and surgical outcomes	Up to 2 years	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.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States