Sufentanil Infusion vs Sufentanil Bolus and Time to Extubation During Routine Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Time to Extubation
研究概览
简要总结
Randomized single blind controlled clinical trial to test the benefit of sufentanil infusion over bolus dosing to reduce time to extubation and reduced length of ICU stay.
详细描述
This study will compare Sufentanil bolus vs infusion and analyze which has a faster extubation time in participants who undergo routine cardiac surgery. The hypothesis is that routine cardiac surgery patients receiving sufentanil infusion will have a lower sufentanil concentration at the end of surgery and have a shorter time to extubation than participants receiving sufentanil bolus dosing even with similar total doses of sufentanil. The intervention will be Sufentanil infusion during surgery and evaluations will include Sufentanil blood concentrations, ICU and hospital length of stay and re-intubation rate. We will follow up with the participants through their ICU stay (primary objective) and hospital length of stay (secondary objective).
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Scheduled non-emergency cardiac surgical patients including those with planned procedures of CABG, AVR, and combined CABG and AVR
- •19 to 80 years old
- •Planned pre-operative anesthesia screening visit and/or preoperative surgical clinic visit.
- •Inpatient subject that is scheduled (greater than 24hrs in advance) for a non-emergency cardiac surgical case
排除标准
- •Sufentanil allergy
- •EF less than or equal to 30%
- •Moderate or severe right ventricular dysfunction,
- •Moderate pulmonary dysfunction, to include patients with at home 02 and/or daily bronchodilator therapy.
- •End Stage Renal Disease on Dialysis
- •Chronic Kidney Disease with GFR <30
- •Sternotomy Re-do
- •Emergency surgery
- •Greater than 4 units of RBCs or FFP combined
- •Mechanical circulatory support post-operatively such as ECMO, IABP, Impella
- •Not eligible for rapid wean extubation protocol
- •Requires infusion of sedative medication required during ICU admission
- •Greater than or equal to 15 minute ICU hold within PACU
研究组 & 干预措施
Sufentanil Bolus
medication in scheduled doses (bolus)
干预措施: Sufentanil Bolus (Drug)
Sufentanil Infusion
medication in a slow trickle (infusion)
干预措施: Sufentanil Infusion (Drug)
结局指标
主要结局
Time to Extubation
时间窗: Amount of time in minutes from procedure finish to time of extubation, up to 800 minutes.
We will determine if sufentanil infusion administration intra-operatively during routine cardiac surgery will decrease time to extubation from OR stop data collection time point by 60 minutes compared to sufentanil bolus administration.
次要结局
- Plasma Concentration(Lab concentration is drawn when patient arrives to ICU, an average of 1 hour after procedure.)