Impact of bispectral index monitoring on dose requirement of dexmedetomidine during total parotidectomy under general anesthesia without use of muscle relaxants.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To compare the intraoperative dexmedetomidine infusion dose requirement with and without bispectral index (BIS) monitoring in patients undergoing total parotidectomy under general anesthesia without use of muscle relaxants.
研究概览
简要总结
It is a Randomised prospective single blinded study, in which we assess the effect of Bispectral Index Monitoring (BIS) in the amount of dexmedetomidine infusion dose required in a case of Parotidectomy surgery without the use of muscle relaxants. In this study we recruit two groups; in one group we use BIS to titrate the infusion dose of Dexmedetomidine intraoperatively; while in the other group we use standard prescribed infusion dose of dexmedetomidine i.e. 0.5mcg/kg/hr and then titrate it according to Hemodynamic Parameters and Patient movements. At the end of the study the collected data will be analysed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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
- •American Society of Anesthesiologists physical status (ASA PS) 2 to 3, -Patients undergoing total parotidectomy with nerve conduction studies.
排除标准
- •Patients with basal HR less than sixty per min, -beta blockers, -heart blocks, -hypersensitivity to dexmedetomidine -nasal intubation or fibreoptic intubation.
结局指标
主要结局
To compare the intraoperative dexmedetomidine infusion dose requirement with and without bispectral index (BIS) monitoring in patients undergoing total parotidectomy under general anesthesia without use of muscle relaxants.
时间窗: End of surgery
次要结局
- To compare intraoperative patient immobility, hemodynamic responses, sevoflurane & propofol consumption, need for intervention if patient moves, incidence of hypotension, use of vasopressors & time taken for extubation in both groups.(patient immobility will be assessed at end of surgery, hemodynamic responses will be assessed every half hourly during surgery, sevoflurane & propofol consumption will be noted at the end of surgery, & the time taken for extubation will be documented at the end of surgery.)
研究者
Dr Sunil Rajan
Amrita Institute of Medical Sciences, Kochi