The Impact of Total Intravenous Anesthesia Following Cancer Surgery (TIVACS) Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Impact of Anesthetic Agent on Inflammation and Immunosuppression
研究概览
简要总结
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.
详细描述
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.
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
- None
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
- •Adults: ≥18 years old on the day of consent
- •Non-metastatic pancreatic adenocarcinoma
- •Able to provide consent
- •ECOG performance status of 0 or 1
- •Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test for the patient at the time of surgery.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Previous identified allergy or hypersensitivity to any component of the study treatment
- •Allergies to eggs, egg products, soybeans, or soy products
- •Personal or first degree relative with a history of malignant hyperthermia
- •Has a known additional malignancy that is expected to require active treatment within two years, or is likely to be life-limiting in the opinion of the treating investigator. Superficial bladder cancer, non-melanoma skin cancers, or low-grade prostate cancer not requiring therapy would not exclude participation in this trial.
- •Uncontrolled intercurrent illness including, but not limited to: Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant or lactating females
- •Major surgery within 2 months before enrollment. Complete healing from major surgery must have occurred 1 month before enrollment. Complete healing from minor surgery (eg, simple excision, tooth extraction) must have occurred at least 7 days before enrollment. Subjects with clinically relevant complications from prior surgery are not eligible.
- •Patients who undergo reoperation during their initial hospitalization will be censored at the time of reoperation.
- •Prisoner status
研究组 & 干预措施
Arm I (surgical resection with TIVA)
Patients undergo surgical resection with TIVA.
干预措施: Anesthesia Procedure (Procedure)
Arm I (surgical resection with TIVA)
Patients undergo surgical resection with TIVA.
干预措施: Resection (Procedure)
Arm II (surgical resection with inhaled volatile anesthetics)
Patients undergo surgical resection with inhaled volatile anesthetics.
干预措施: General Anesthesia Procedure (Drug)
Arm II (surgical resection with inhaled volatile anesthetics)
Patients undergo surgical resection with inhaled volatile anesthetics.
干预措施: Resection (Procedure)
结局指标
主要结局
Impact of Anesthetic Agent on Inflammation and Immunosuppression
时间窗: Up to 2 years
All data analysis will use Student's t-test, Chi2 test and multivariable regression analysis using linear mixed model. The incidence of these outcomes will also be associated with NET levels.
次要结局
- Impact of Anesthetic Choice on Short-term Anesthetic and Surgical Outcomes(Up to 2 years)