VIVA: Volatile or IV Anesthesia for Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Neutrophil extracellular traps (NET) formation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and statisticians are blinded to the type of anesthesia.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Biospecimen Collection (Procedure)
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.
干预措施: Electronic Health Record Review (Other)
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.
干预措施: Fentanyl Citrate (Drug)
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.
干预措施: Propofol (Drug)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Sevoflurane (Drug)
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.
干预措施: Surgical Procedure (Procedure)
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.
干预措施: Biospecimen Collection (Procedure)
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.
干预措施: Electronic Health Record Review (Other)
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.
干预措施: Fentanyl Citrate (Drug)
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.
干预措施: Propofol (Drug)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Surgical Procedure (Procedure)
结局指标
主要结局
Neutrophil extracellular traps (NET) formation
时间窗: Post-operative day (POD) 1 to POD 6 months
The Neutrophil extracellular traps (NET) formation will be assessed by DNA complexes in myeloperoxidase (MPO). MPO are enzymes that come from white blood cells. The level of these enzymes will be compared by study group using statistical models. The time you are under anesthesia, the amount of anesthesia you are given, the type of surgery you have are all variables that will be considered when evaluating the two types of anesthesia.
次要结局
- Post-operative nausea scores(Post-Operative Day 0 to post-operative discharge, approximately 2-4 days)
- Number of times a pro re nata (PRN) medication administered(Post-Operative Day 0 to post-operative discharge, approximately 2-4 days)
- Changes in gene expression(Immediately post-operatively)
- Early post-operative recovery(Post-Operative Day 0 to post-operative discharge, approximately 2-4 days)
- Global and post-operative recovery(Post-Operative Day 0 to 6 months post-operatively)
- Number and cumulative amount of doses of anti-emetics(Post-Operative Day 0 to post-operative discharge, approximately 2-4 days)
- Patient-reported pain scores(Post-Operative Day 0 to post-operative discharge, approximately 2-4 days)
- Post-operative complications(Post-Operative Day 0 to Three Months Post-Operatively)
- Total hospital opioid use(Post-Operative Day 0 to post-operative discharge, approximately 2-4 days)
- First post-op day when participant tolerates a regular diet (at the discretion of the surgical team)(Post-Operative Day 0 to post-operative discharge, approximately 2-4 days)
- Post-operative immune suppression(Post-Operative Day 1 to 6 months Post-Operatively)
- Circulating tumor deoxyribonucleic acid (ctDNA)(Post-Operative Day 0 up to 5 years)
- Time from study entry and from surgery to disease recurrence, death, or loss to follow up(Post-Operative Day 0 up to Five Years Post-Operation)
研究者
Luke Selby
Principal Investigator
University of Kansas Medical Center