Comparison of endtidal sevoflurane concentration required for optimal depth of anaesthesia during opioid free general anesthesia using intravenous lignocaine versus standard care.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary objective is to compare the endtidal sevoflurane concentration required to maintain intraoperative bispectoral index (BIS) values between 40 to 60 au in patients receiving opioid free anesthesia (OFA) using intravenous lignocaine versus standard regimen using morphine during tumor resection in patients with head and neck malignancies undergoing wide excision and reconstruction surgeries.
研究概览
简要总结
This is a prospective randomized single blinded study.There will be 2 group of patients . Groupl L will receive lignocaine at a bolus dose of 1.5mg/kg followed by a infusion dose of 1mg/kg/hour and group b will receive morphine at dose of 0.2mg/kg followed by an infusion dose of 2mg/hr .The primary objective is to compare the end tidal sevoflurance concentration required for optimal depth of anaesthesia in patients receiving lignocaine and standard morphine in patients with head and neck malignancies undergoing tumour resection and reconstructive surgeries to maintain an intraoperative BIS between 40 to 60 . The secondary objectives include comparison of BIS during induction, nasal intubation and anastomosis of flap, intraoperative changes in heart rate, mean arterial pressure ,consumption of sevoflurane,need for additional analgesics , incidence of hypertension/bradycardia/hypotension/arrhthymia,recall of events on 2nd post operative day and need to stop opioid free analgesics. Data from both groups will be compared.
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, Carcinoma tongue and alveolus undergoing tumor resection surgeries requiring nasal intubation.
排除标准
- •i.Patients with basal HR <60/min, ii.on beta blockers, iii.having cardiac arrhythmias, heart blocks, congestive heart failure, iv.liver disorders with aspartate aminotransferase /alanine transaminase >2-3 times normal v.renal diseases with estimated glomerular filtration rate <60ml/min/1.73m2 vi.hypersensitivity to lignocaine vii.awake fiberoptic bronchoscope assisted intubation, viii.carcinoma maxilla, craniofacial resection, exenteration, scalp, mastoid and surgeries requiring neuro assistance ix.supplemental regional anaesthesia.
结局指标
主要结局
The primary objective is to compare the endtidal sevoflurane concentration required to maintain intraoperative bispectoral index (BIS) values between 40 to 60 au in patients receiving opioid free anesthesia (OFA) using intravenous lignocaine versus standard regimen using morphine during tumor resection in patients with head and neck malignancies undergoing wide excision and reconstruction surgeries.
时间窗: at start to end of surgery
次要结局
- 1)comparison of BIS during induction, nasal intubation and anastomosis of free flap, 2)intraoperative changes in heart rate and mean arterial pressure,(3)consumption of sevoflurane, need for additional analgesic like low dose ketamine or dexmedetomidine,)
研究者
Dr Sunil Rajan
AMRITA INSTITUTE OF MEDICAL SCIENCES