Impact of Total Intravenous Anesthesia Following Cancer Surgery, TIVACS Study

Pancreatic Adenocarcinoma Clinical Trial

Official title:

The Impact of Total Intravenous Anesthesia Following Cancer Surgery (TIVACS) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04992507
• Other study ID #: OSU-20306
• Secondary ID: NCI-2021-05849
• Status: Completed
• Phase: Phase 2
• Start date: June 2, 2023
• Est. completion date: January 26, 2024

Study information

• Verified date: April 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 26, 2024
• Est. primary completion date: January 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

Intervention

Procedure:
• Anesthesia Procedure
Given TIVA

Drug:
• General Anesthesia Procedure
Given inhaled volatile anesthetics

Procedure:
• Resection
Undergo surgical resection

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Impact of anesthetic choice on short-term anesthetic and surgical outcomes	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

External Links

•   The Jamesline