The Role of Ketamine and Dexmedetomidine in Opioid-Sparing Analgesia and Sedation in Adult Patients After Cardiac Surgery. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The total postoperative fentanyl consumption (μg)
研究概览
简要总结
Optimal multimodal opioid-sparing analgesic technique is considered as one of the most important Enhanced recovery pathways (ERPs) or enhanced recovery after surgery (ERAS) interventions that mitigate the undesirable effects of surgical stress response. Implementation of ERP has been shown to reduce postoperative complications and shorten the hospital LOS.
详细描述
In this study, the investigator hypothesizes that by using continuous infusion of ketamine or dexmedetomidine in addition to NSAIDs, the investigator can reduce or completely eliminate opioid use in adult patients after cardiac surgery.
The anesthesia technique was composed of the following 10 steps:
- Premedication with oral Pregabalin 75 mg the night before surgery;
- For induction and maintenance of anesthesia: - Midazolam 0.02- 0.05 mg/kg bolus, -Fentanyl (cumulative dose 5-15 μg/kg), followed by continuousInfusion of Fentanyl; 2-3 μg/kg /h as a maintenance dose, Rocuronium: (0.6-1.0 mg/kg - intubation dose, followed by continuous Infusion of Rocuronium; 0.075-0.15 mg/kg/h as a maintenance dose, and Sevoflurane in a dose of 0.8-1.0 (MAC).
- Ventilation: Lung protective ventilation (Vt 6 ml/kg predicted body weight, + PEEP 5, + FiO2 60%), and we conducted a recruitment maneuver in order to prevent atelectasis.
- Monitoring: Routine monitors (ECG, SpO2, arterial line inserted using local anesthesia for pressure monitor and repeated ABG, Central line inserted after induction of anesthesia for monitoring CVP, ETCO2, core temperature through urinary catheter, and Activated Clotting Time (ACT) for monitoring of coagulation). Cerebral oximetry, and Bispectral Index (BIS) as an indicator of depth anesthesia was kept between 40 and 60. (5) Cardiopulmonary Bypass (CPB): Goal directed perfusion maintaining MAP ≥ 60, using Phenylephrine and Norepinephrine infusion. Additional propofol infusion (25 - 50µg/kg/min) was administered during CPB to maintain BIS between 40 and 60. Smooth conduct of CPB, with Mild hypothermia (28°C 32°C). Rewarming at the end of the procedure, Goal postop temperature >36 °C.
(6) Perioperative Glycemic Control: Insulin infusion, and the perioperative Goal glucose ≤ 150 - 180.
(7)Perioperative hemoglobin concentration: Goal hemoglobin transfusion trigger: 7.5 regardless of patient Age and Comorbidity. (8) Protamine: Post CPB protamine (heparin reversal) given up to the full dose (5 mg/kg after test dose) to return to baseline ACT.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 65 years
- •Ejection fraction (EF) > 35%
- •Elective isolated CABG
- •Valve surgery, Atrial septal defect (ASD) closure
- •Cross clamp time ≤ 90 min
- •Cardiopulmonary bypass time ≤ 120 min.
排除标准
- •Poor left ventricular function with intra-aortic balloon pump support
- •Recent myocardial infarction (last seven days)
- •Combined procedure (i.e., CABG + other heart/vascular procedure)
- •Emergency surgery, and Redo surgery,Hepatic or renal failure, creatinine >1.5 -History of neurological disorders or convulsions
研究组 & 干预措施
Group (K)
Group (K): (n=30) will receive ketamine infusion 1-2 μg/kg/min (0.12 mg/kg/h) titrated to desired level of sedation.
干预措施: Ketamine (Drug)
Group (D)
Group (D): (n=30) will receive Dexmedetomidine infusion 0.1- 0.2 μg/kg/hour titrated to desired level of sedation.
干预措施: Ketamine (Drug)
Group (C)
Group (C): (n=30) will receive fentanyl only.
干预措施: Ketamine (Drug)
结局指标
主要结局
The total postoperative fentanyl consumption (μg)
时间窗: the first 48 hours postoperative
the total doses of postoperative fentanyl consumption in (μg)
次要结局
- Duration of mechanical ventilation(the first 48 hours postoperative)
研究者
Mohamed Ahmed Hamed
ASSOCIATE PROFESSOR OF ANESTHESIA
Fayoum University Hospital
