Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06017141
Status:
RECRUITING
Last Update Posted:
2023-08-30
First Post:
2023-07-31
Brief Title:
Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer VIVA Study
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
VIVA Volatile or IV Anesthesia for Cancer
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 bodys 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-05587 | OTHER | None | None |
| IIT-2022-VIVA | OTHER | None | None |
| STUDY00149314 | OTHER | None | None |
| P30CA168524 | NIH | University of Kansas Cancer Center | httpsreporternihgovquickSearchP30CA168524 |