NCT04992507

Impact of Total Intravenous Anesthesia Following Cancer Surgery, TIVACS Study

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Anesthesia Procedure	Given TIVA
DRUG	General Anesthesia Procedure	Given inhaled volatile anesthetics
PROCEDURE	Resection	Undergo surgical resection

Timeline

• Start date: 2023-06-02
• Primary completion: 2024-01-26
• Completion: 2024-01-26
• First posted: 2021-08-05
• Last updated: 2025-07-10
• Results posted: 2025-07-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study