Recruiting
Phase 2

Inhalational & Intravenous Anesthesia

Sponsor:

University of Kansas Medical Center

Code:

NCT06017141

Conditions

Colon Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Electronic Health Record Review

Fentanyl Citrate

Propofol

Questionnaire Administration

Study Details

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 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.

Conditions

Colon Adenocarcinoma

Study ID

NCT06017141

Start date

May 22, 2023

Status verified date

Aug, 2023

Completion date

May 22, 2026

Anticipated

Primary completion date

May 22, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
  • Males and females age >= 18 years on day of consent
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
  • Patients undergoing resection for biopsy proven colon adenocarcinoma
  • Medically fit for colon resection
  • Ability to complete required study questionnaires
  • Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

  • Diagnosis of rectal adenocarcinoma
  • Simultaneously enrolled in any therapeutic clinical trial. Subsequent enrollment in an adjuvant therapy clinical trial is not automatically prohibited by this trial. Trial eligibility for subsequent studies will be determined by the VIVA principal investigator (PI) and the PI of the other clinical trial in question
  • Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
  • Active grade 3 (per the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment
  • Prisoner status
  • Allergies to eggs, egg products, soybeans, or soy products (relative or absolute contraindication to propofol)
  • Personal or first degree relative with a history of malignant hyperthermia (absolute contraindication to inhaled volatile anesthetics)
  • Diagnosis of inflammatory bowel disease
  • Planned multi-visceral resection (examples include: pelvic exenteration, combined liver and colon resection)
  • Patients undergoing resection for unresectable polyps, or incomplete polypectomies without biopsy proven adenocarcinoma are excluded

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm I (sevoflurane, fentanyl citrate, propofol)

Patients receive SOC sedation with sevoflurane via inhalation and fentanyl IV on study during to SOC surgery. All patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery.

experimental: Arm II (fentanyl citrate, propofol)

Patients receive SOC sedation with fentanyl IV and propofol IV on study during to SOC surgery. Patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery.

Interventions

Biospecimen Collection

Undergo blood and tissue sample collection

Electronic Health Record Review

Ancillary studies

Fentanyl Citrate

Given via injection

Propofol

Given IV

Questionnaire Administration

Ancillary studies

Sevoflurane

Given via inhalation

Surgical Procedure

Undergo SOC surgery

Primary outcome measure

  • Neutrophil extracellular traps (NET) formation [ Time Frame: Post-operative day (POD) 1 to POD 6 months ]

Central Contacts and Locations

Locations

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Luke V. Selby

913-588-7750lselby@kumc.edu

Principal Investigator:

Luke V. Selby

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Aug 30, 2023

Last verified

Aug, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2023-08-30.