A Double-blinded, Randomized Control Trial of Prophylactic Ondansetron in a Post-operative Cardiac Surgery Population for Post-operative Nausea and Vomiting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Occurrence of Post-operative Nausea and Vomiting (PONV)
研究概览
简要总结
To evaluate the effectiveness of a prophylactic dose of ondansetron in decreasing the incidence of post-operative nausea and vomiting in cardiac surgery patients after cessation of post-operative sedation. In patients who have undergone open heart surgery, a single prophylactic dose of ondansetron 4 mg IV given at the time of discontinuing propofol sedation will result in a 50% reduction of the rate of post-operative nausea and vomiting in the first 24 post-operative hours compared to placebo.
详细描述
Post-operative nausea and vomiting (PONV) is a significant source of morbidity for patients undergoing general anesthesia, and in particular, patients undergoing cardiac anesthesia. Despite its common occurrence, literature on PONV prophylaxis in the cardiac surgical population is limited relative to other surgical populations.
A rational approach to preventing PONV would be to administer prophylaxis prior to extubation once post-operative sedation has ceased. This timing of administration would be more standardized across patients, as duration of surgery and time of extubation after surgery can vary considerably, rendering plasma levels of PONV prophylaxis agents highly variable across patients.
At St. Paul's Hospital, PONV prophylaxis has not been a routine part of cardiac anesthesia care. Furthermore, there are no standardized guidelines, and practice varies between care providers. Following surgery, patients recover from anesthesia and are extubated in the cardiac surgery ICU (CSICU). They are usually sedated on a propofol infusion for one to four hours after surgery until they are ready for extubation. When PONV occurs, the first line drug for treatment is ondansetron 4 mg. The investigators therefore propose the use of a single, prophylactic dose of ondansetron (4 mg IV), given at the time of propofol cessation. A randomized, double blinded placebo controlled model will be utilized
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective (outpatient) and urgent (inpatient) cardiac surgery procedures requiring cardiopulmonary bypass, including:
- •Coronary artery bypass grafting (CABG)
- •Valve surgery (ie. repair and/or replacement)
- •CABG and valve surgery
排除标准
- •Undergoing 'off-pump' CABG (not involving the cardiopulmonary bypass machine)
- •With a contraindication to the study drug - including but not limited to congenital Long QT Syndrome, allergy to ondansetron, or a history of migraines
- •Unable to understand the consent process, either due to language limitations or cognitive limitations if a translator or substitute decision maker is not available
- •Receiving heart transplants, ventricular assist devices or on extra-corporeal membrane oxygenation (ECMO)
- •Intubated for more than 12 hours post-operatively
- •With a known history of PONV
- •Sedated with dexmedatomine instead of propofol
研究组 & 干预措施
Ondansetron
Ondansetron 4mg IV at time of discontinuation of Propofol Infusion
干预措施: Ondansetron (Drug)
Saline
2 mL IV Normal Saline at time of discontinuation of Propofol Infusion
干预措施: Saline (Drug)
结局指标
主要结局
Occurrence of Post-operative Nausea and Vomiting (PONV)
时间窗: First 24 hours post-extubation
Measured by asking the patient hourly to assess their post operative nausea and vomiting using a 10-point verbal Likert rating scale.
次要结局
- Dose of any Rescue PONV medication(First 24 hours post-extubation)
- Time to first report of nausea or first vomit post-operatively(First 24 hours post-extubation)
- Incidence of Rescue PONV medication administration(First 24 hours post-extubation)
- Incidence of Post-operative nausea without vomiting(First 24 hours post-extubation)
- Severity Post-operative nausea without vomiting(First 24 hours post-extubation)
- Time to first dose of rescue PONV medication(First 24 hours post-extubation)
- Incidence of ventricular arrhythmias(first 24 hours post-extubation)
研究者
Matthew Coley
Clinical Assistant Professor
University of British Columbia