To evaluate the effect of combination of lidocaine and ketamine infusion on attenuation of hemodynamic response to intubation,skin incision and sternotomy in open adult valvular heart surgeries.A double blinded randomized controlled study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in heart rate, blood pressure, during intubation, skin incision, and sternotomy
研究概览
简要总结
Hemodynamic stability is crucial during cardiac surgery to ensure adequate organ perfusion and improve outcomes. Surgical stimuli such as laryngoscopy, intubation, skin incision, and sternotomy can provoke significant sympathetic responses, leading to increased heart rate and blood pressure—potentially harmful in patients with heart disease. Conventional drugs have limited success in attenuating these responses. Lidocaine and ketamine, due to their analgesic, anti-inflammatory, and cardiovascular properties, may help stabilize intraoperative hemodynamics and reduce anesthetic requirements. However, limited data exist on their effects during open valvular heart surgeries. This study aims to evaluate their efficacy in blunting hemodynamic responses during such procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Adult patients aged between 18 to 75 years, scheduled for elective open valvular heart surgery Both male and female patients will be included Patients with left ventricular ejection fraction (LVEF) greater than 40%, assessed by echocardiography within 1 week prior to surgery Patients undergoing elective open valvular heart surgery via median sternotomy American Society of Anesthesiologists (ASA) physical status classification Grade II or III Patients who provide written informed consent.
排除标准
- •Patient refusal Allergy to the study drug History of opioid abuse History of any addiction Cognitive dysfunction Raised intracranial pressure.
结局指标
主要结局
Changes in heart rate, blood pressure, during intubation, skin incision, and sternotomy
时间窗: At the time of intubation, 5 minutes after intubation, at the time of skin incision,sternotomy,5minutes after sternotomy
次要结局
- Total dose of Propofol and Fentanyl required(Intubation, skin incision , and sternotomy)
研究者
M Mahendra Naik
AIIMS RAIPUR
