NCT06017141

Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer, VIVA Study

VIVA: Volatile or IV Anesthesia for Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial evaluates how inhalational anesthesia (drawn in through the lungs) and total intravenous anesthesia (TIVA) (through a needle in a vein in the arm) change the body's ability to recover from surgery or whether they impact the immune system immediately after surgery in patients with colon cancer. It is unknown whether these types of anesthesia change recovery from surgery or change the chances cancer comes back following surgery. This study may help researchers learn how different types of anesthesia affect recovery from colon cancer surgery.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the differential impact of TIVA versus inhaled anesthesia on neutrophil extracellular traps (NET) inflammation and immunosuppression among patients undergoing cancer surgery. SECONDARY OBJECTIVES: I. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on patient reported post-operative recovery: Ia. Overall, and domain-specific post-operative recovery (as measured by the Quality of Recovery Score \[QoR\]-40) on the day of discharge and other post-operative timepoints; Ib. Changes in overall and domain-specific post-operative recovery over time. II. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on peri-operative clinical and anesthetic outcomes, as recorded in the electronic medical record (EMR), including: IIa. Post-operative nausea and vomiting (from medical record); IIb. Post-operative pain (measured on a 1-10 scale) (from medical record); IIc. Return of gastrointestinal (GI) function (from medical record); IId. Post-operative cognitive impairment (from medical record); IIe. 30 and 90 days post-operative complications; IIf. Disease-free survival (from medical record); IIg. Overall survival (from medical record). III. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on circulating levels of inflammatory cytokines, immune cell populations, global inflammatory markers. IV. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on levels of circulating tumor DNA (ctDNA) at multiple post-operative timepoints according to standard of care practices of the University of Kansas Medical Center (KUMC) Division of Medical Oncology GI oncology practice. V. Correlation of peri-operative clinical and anesthetic outcomes to neutrophil extracellular traps (NET) levels, measures of immune suppression, ctDNA. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive standard of care (SOC) sedation with sevoflurane via inhalation and fentanyl intravenously (IV) on study prior to SOC surgery. Some patients may also receive sedation with propofol IV prior to surgery. All patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery. ARM II: Patients receive SOC sedation with fentanyl IV and propofol IV on study prior to SOC surgery. Patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery. After completion of study treatment, patients are followed up at 1 and 3 days, 3 and 6 weeks, 3 and 6 months, and then yearly for 5 years from SOC surgery.

Conditions

• Colon Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood and tissue sample collection
OTHER	Electronic Health Record Review	Ancillary studies
DRUG	Fentanyl Citrate	Given via injection
DRUG	Propofol	Given IV
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Sevoflurane	Given via inhalation
PROCEDURE	Surgical Procedure	Undergo SOC surgery

Timeline

• Start date: 2023-05-22
• Primary completion: 2025-05-22
• Completion: 2026-05-22
• First posted: 2023-08-30
• Last updated: 2023-08-30

Locations

1 site across 1 country: United States