A Comparative Study To Evaluate The Effects Of Preoperative Dexmedetomidine Nebulization Vs Lignocaine and normal saline Nebulization On The Hemodynamic Response To Laryngoscopy And Intubation
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To prevent hemodynamic stress response to laryngoscopy and intubation
研究概览
简要总结
Patients undergoing elective surgery requiring laryngoscopy and tracheal intubation will be recruited in this study. Pre -anesthetic check-up will be carried out in all patients. On arrival to operation theatre, Standard intraoperative monitoring- electrocardiogram, pulse oximetry and non-invasive blood pressure will be attached and baseline vitals will be noted. Participants will be allotted in to two groups.Group A will receive pre-operative nebulization with Dexmedetomidine at a dose of 0.75 mcg/kg in 2 ml of 0.9% saline,20 min before induction of anesthesia and Group B will receive pre-operative nebulization with Lignocaine 2% 2ml in 2 ml of 0.9% saline, 20 min before induction of anesthesia .The drugs for nebulization (dexmedetomidine or lignocaine) will be prepared and administered by an independent investigator in the preoperative holding area. Hemodynamic parameters such as Heart Rate, Systolic & Diastolic BP, pulse oximetry will be recorded before nebulization. Nebulization will be carried out with an electrical compressor nebulizer, capable of creating a fine mist until the entire volume is dispersed–usually within 15–20 min. Pre-oxygenation will be done with 100% O2 for 3 minutes. Hemodynamic parameters such as Heart Rate, Systolic & Diastolic BP, pulse oximetry will be recorded before induction of general anesthesia. After which induction agent as per choice in concentration approved and Hemodynamic parameters will be then recorded every 1 minute till 10 minutes after laryngoscopy. Intubation will be confirmed by EtCO2 and bilaterally equal air entry and then connected to a ventilator for intermittent positive pressure ventilation until completion of surgery. Patients will be kept in the postoperative care unit for an additional 1 hour and discharged to the ward once they met the criteria for discharge (i.e., Aldrete recovery scale). The presence of postoperative sore throat will be noted as present or absent. As per literature, Nebulization Dexmedetomidine has less systemic bioavailability hence incidence of side effects should be reduced, if any side effects happened like clinically relevant hypotension will be defined as decrease in mean arterial pressure 20% or more from base line. In that case inj. crystalloids bolus will be given and if required vasopressor support may be given. Nebulized lidocaine also appears to be well tolerated by patients with minimal side effects including dysphonia, oropharyngeal numbness, and bitter taste
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient undergoing elective surgeries requiring general anesthesia and tracheal intubation and Belonging to ASA grade 1 2 and 3.
排除标准
- •Patients unwilling to participate Patients with renal hepatic cardiovascular or respiratory diseases belonging to ASA grade 4 or more Pregnant and lactating women Patient with history of allergy to dexmedetomidine and lignocaine Patient with sore throat dry cough local factors in nose and mouth pre operatively.
结局指标
主要结局
To prevent hemodynamic stress response to laryngoscopy and intubation
时间窗: At the time of incision at 0 minute and post extubation
次要结局
- To see if lesser amount of propofol is required(During laryngoscopy and intubation)
研究者
Dr Alpa Patel
Pramukh swami medical college
