Dexmedetomedine as a perioperative adjunct in patients undergoing cardiac surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- To assess the effects of Dexmedetomidine on hemodynamics and depth of anesthesia in patients undergoing valvular heart replacement surgeries
研究概览
简要总结
Dexmedetomidine is a potent, highly selective alpha-2 adrenoceptor agonist with sedative, analgesic, anxiolytic, anti-sympathetic and opioid-sparing properties. It is known to act as a useful adjunct by reducing the needs for opioids, inhalational agents as well as intravenous agents. It has been shown to reduce the anaesthetic and opioid requirement in patients undergoing cardiac surgeries. It has also proven to provide hemodynamic stability,owing to its effect in controlling the adrenocortical as well as cardiac function in patients undergoing vascular surgery, a patient population, who have a high incidence of coronary artery diseases. In addition, it leads to a decrease in plasma levels of cortisol, epinephrine, norepinephrine and serotonin and provides cardioprotective effects. It, thus, appears to be a useful agent during cardiac surgery. The present study is conducted to assess the efficacy of Dexmedetomidine when used as an adjunct in Cardiac surgeries on hemodynamic stability, maintenance of depth of anesthesia and post-operative outcomes. The data obtained from patient records would include
1. Patient demographics including diagnosis, surgery and ASA grading.
2. Premedications given.
3. Baseline hemodynamics like Heart rate, Mean Arterial Pressure, Central Venous Pressure, Near Infrared Spectroscopy and Entropy (SE, RE) values.
4. Heart rate, Mean Arterial Pressure, Central Venous Pressure, Near Infrared Spectroscopy and Entropy (SE, RE) values post induction.
5. Heart rate, Mean Arterial Pressure, Central Venous Pressure, Near Infrared Spectroscopy and Entropy (SE, RE) values after Sternotomy.
6. Heart rate, Mean Arterial Pressure, Central Venous Pressure, Near Infrared Spectroscopy and Entropy (SE, RE) values after pericardiotomy.
7. Heart rate, Mean Arterial Pressure, Central Venous Pressure, Near Infrared Spectroscopy and Entropy (SE, RE) values 5 minutes after protamine administration.
8. Heart rate, Mean Arterial Pressure, Central Venous Pressure, Near Infrared Spectroscopy and Entropy (SE, RE) values at the end of surgery.
9. Post operative time of extubation.
10. Post Operative events with their cause and time would be noted namely reintubation, reoperation, Atrial fibrillation, acute kidney injury, Type 1 neurological injury(defined as new episode of motor deficit, coma, seizure or encephalic lesion documented by cranial computed tomography or magnetic resonance imaging), ICU readmission, ICU length of stay, 30- day mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing valvular cardiac surgery.
排除标准
- •Preoperative treatment with morphine or its derivatives including tramadol in the 15 days preceding the inclusion visit Pre-existing high-degree conduction disorder Oxygen therapy prior to inclusion Heart failure with LVEF less than 40 percent BMI more than 35 Myocardial suffering in the 5 days preceding surgery Patient in shock Known adrenal insufficiency and or long-term systemic corticosteroid treatment equivalent to hydrocortisone hemisuccinate more than 20 mg per day Long-term non-invasive ventilation including for obstructive sleep apnea syndrome Any antecedent or active practices of drug addiction Contraindication to one of the experimental and or nonexperimental treatment like dexmedetomidine lidocaine dexamethasone ketamine remifentanil or morphine Acute cerebrovascular pathology Severe hepatic insufficiency with factor V level less than 50 percent Pre-existing cognitive disorders Pregnant or parturient or breastfeeding woman Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection under guardianship or guardianship Patient participating in another drug trial or having participated in another drug trial within 1 month before randomization.
结局指标
主要结局
To assess the effects of Dexmedetomidine on hemodynamics and depth of anesthesia in patients undergoing valvular heart replacement surgeries
时间窗: Baseline | post induction | after Sternotomy | after pericardiotomy | 5 minutes after protamine | administration | end of surgery
次要结局
- To assess duration of ICU stay & incidences of postoperative complications which received Dexmedetomidine perioperatively(Admission to ICU after surgery)
研究者
Dr Sanjeeta Umbarkar
Seth GS Medical collage and KEM Hospital