Volatile Anaesthesia and Perioperative Outcomes Related to Cancer (VAPOR-C): A Feasibility Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- To measure the ability to successfully deliver each of the two anaesthetic techniques (volatile-based general anaesthesia and propofol-based anaesthesia) according to the research protocol.
研究概览
简要总结
A multicentre, prospective randomized, active-controlled feasibility trial of volatile-based anaesthesia vs. propofol-based total intravenous anaesthesia to investigate the impact of anaesthesia on long-term (i.e. 5-years) patient cancer outcomes in patients undergoing elective major cancer surgery.
详细描述
This study aims to assess the feasibility of conducting a phase IV, multi-centre, single-blinded, randomized control trial (VAPOR-C (Main)).
Primary aims To measure the ability to recruit eligible patients into the study.
To measure the ability to successfully deliver each of the two anaesthetic techniques (volatile-based general anaesthesia and propofol-based anaesthesia) according to the research protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients are blinded to the anaesthetic type given. Statistician also blinded.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Age 18-80 years
- •Elective surgery
- •Major cancer surgery expecting to last two or more hours, for:
- •Breast (mastectomy or segmentectomy plus sentinel node dissection)
- •Colorectal
- •Melanoma (excision of melanoma plus lymph node dissection AND/OR skin flap construction
- •Other major cancer surgeries (e.g. oesophagectomy, head and neck cancer, etc.)
- •Exclusion Criteria
- •Palliative surgery for end-stage disease with no curative intent
- •Emergency surgery
- •Extensive comorbid disease, i.e. American Society of Anesthesiologists (ASA) Score > 4
- •Age <18 or >80 years old
- •Refusal or inability to provide valid informed consent
- •Risk of severe postoperative nausea and vomiting (PONV risk score >3)
- •Previous allergy or contraindication to either anaesthetic medication
- •Indication for gas induction of anaesthesia
- •Currently enrolled in another clinical trial unless agreed by the coordinating principal investigator and site principal investigator that co-enrolment can occur.
排除标准
- 未提供
研究组 & 干预措施
Propofol (TIVA)
Propofol-based total intravenous anaesthesia
干预措施: Propofol (Drug)
Volatile
Volatile-based (isoflurane, sevoflurane or desflurane) general anaesthesia
干预措施: isoflurane, sevoflurane or desflurane (Drug)
结局指标
主要结局
To measure the ability to successfully deliver each of the two anaesthetic techniques (volatile-based general anaesthesia and propofol-based anaesthesia) according to the research protocol.
时间窗: 18 months
The study protocol will be assessed as feasible if a successful delivery rate of at least 90% is achieved.
To measure the ability to recruit eligible patients into the study.
时间窗: 18 months
The study protocol will be assessed as feasible if a recruitment rate of at least 75% is achieved.
次要结局
- To identify that all sites can capture data within the electronic case report form (eCRF) and utilize the electronic data capturing system (REDCap).(18 months)
- To test the efficiency of the centralized patient enrolment and computer randomization system.(18 months)