Opioid-free Anesthesia for Open Cardiac Surgery: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Mean arterial blood pressure-time integral
研究概览
简要总结
This study will compare an opioid free anesthetic, using dexmedetomidine, to a traditional opioid based anesthetic, using fentanyl, for patients undergoing cardiac surgery with regards to hemodynamic stability in the first 10 minutes after induction.
详细描述
This is a single center, blinded, prospective, randomized controlled trial. A total of 158 subjects (79 subjects in each arm) are planned. The control group will receive a traditional cardiac anesthetic using opioids, for which induction will include fentanyl and propofol. The experimental arm will receive an opioid free anesthetic with an induction bolus of dexmedetomidine and propofol. The investigators hypothesize that using the opioid free technique will be more hemodynamically stable within the first 10 minutes of induction.
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
- Single (Participant)
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
- •Male or female ≥ 18 years of age at the time of consent.
- •Undergoing non-emergent open cardiac procedures requiring cardiopulmonary bypass support, including: CABG, aortic aneurysm repair, valve repair/replacement, or CABG in combination with valve repair/replacement.
- •Ability and willingness to provide written informed consent.
排除标准
- •Chronic opioid use defined as preoperative MED >100 daily.
- •Hypersensitivity or contraindication to any of the study medications.
- •Pre-existing Alzheimer's/vascular dementia.
- •Pre-existing psychiatric disorder precluding ability to provide informed consent or use a visual analogue scale for pain.
- •Childs-Pugh Class C liver failure or acute liver failure.
- •Emergent open heart surgery, including type A aortic dissections, trauma, or conversion (bail out) from another procedure such as cardiac catheterization, ablation, transcatheter aortic valve replacement or any other general surgical procedure.
- •Pregnancy or lactating.
- •Inability to comply with the requirements of the study, per investigator judgment.
- •Patients determined to need an awake intubation.
研究组 & 干预措施
Opioid-based anesthetic
Premedication
-midazolam 2mg IV x 1 as need for anxiety, at the discretion of the anesthesiologist
Induction
- Fentanyl 2-4 mcg/kg IV bolus
- Propofol 1-3 mg/kg IV
- Paralytic and vasoactive medications at the discretion of the anesthesiologist
Maintenance
- Fentanyl 1-2 mcg/kg IV bolus immediately prior to sternotomy & aortic cannulation
- Fentanyl 1-2mcg/kg IV bolus immediately following removal of bypass cannula
- Dexmedetomidine 0.4 mcg/kg/hr IV infusion
- Isoflurane titrated at the discretion of the anesthesiologist
- Vasoactive medications at the discretion of the anesthesiologist for hemodynamic management
During chest closure:
- start Propofol 25-75mcg/kg/min IV infusion
- continue dexmedetomidine 0.4mcg/kg/hr IV infusion
- titrate off isoflurane
- Acetaminophen 1000mg IV
干预措施: Opioid Anesthetics (Drug)
Opioid-free anesthetic
Premedication
-midazolam 2mg IVx1 as needed for anxiety, at the discretion of the anesthesiologist
Induction
- Dexmedetomidine 1mcg/kg IV
- Propofol 1-3mg/kg IV
- Paralytic and vasoactive medications at the discretion of the anesthesiologist
Maintenance
- Dexmedetomidine 0.8-1.0 mcg/kg/hr IV infusion
- Isoflurane titrated at the discretion of the anesthesiologist
- May add propofol infusion if clinically indicated
- Vasoactive medications at the discretion of the anesthesiologist for hemodynamic management
During chest closure:
- start Propofol 25-75mcg/kg/min IV infusion
- continue dexmedetomidine 0.4 - 1.0 mcg/kg/hr IV infusion
- titrate off isoflurane
- Acetaminophen 1000mg IV
干预措施: Non Opioid Analgesics (Drug)
结局指标
主要结局
Mean arterial blood pressure-time integral
时间窗: 10 minutes
The primary endpoint is the area under the baseline mean arterial pressure (MAP) over the first 10 minutes after induction, called the MAP-time integral.
次要结局
- Blood pressure variability pre-cardiopulmonary bypass(2 hours)
- Heart rate variability pre-cardiopulmonary bypass(2 hours)
- Vasopressor usage intra- and post-operatively(18 hours)
- Arrhythmias or EKG changes(14 days)
- Delirium medications(24 hours)
- Delirium(24 hours)
- Postoperative pain scores(24 hours)
- Opioid consumption(24 hours)
- Postoperative nausea/vomiting(24 hours)
- Time to extubation(1-36 hours)
- ICU length of stay(1-5 days)
- Hospital length of stay(3-14 days)
- Reintubation or readmission to ICU(0-14 days)
- major adverse cardiovascular event or mortality(30 days)
- Postoperative pain questionnaire(6 months)