A randomized comparative study to compare intubation conditions using dexmedetomidine alone versus combination of dexmedetomidine and fentanyl during awake fibre optic intubation in patients undergoing elective Head and Neck cancer surgeries in department of Anaesthesia SMS Medical College and Attached Hospitals Jaipur
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean Ramsay sedation score, percentage of intubation score, percentage of airway obstruction score, mean intubation Comfort score, percentage post intubation score
研究概览
简要总结
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Awake fibreâ€optic intubation (AFOI) is an integral part of anaesthetic management of difficult airways. Conscious sedation is essential to assist AFOI.
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Dexmedetomidine, a selective alpha-2 adrenoreceptor agonist, is the agent of choice for many practitioners to achieve sedation in AFOI because of its advantages over the other drugs. It produces profound sedation with easy arousability, without respiratory depression. Furthermore, it has the added advantage of having anxiolytic and analgesic properties. It decreases the salivary secretions, thereby allowing better visualization through the fiberscope.
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However, at higher doses it can result in cardiovascular depression causing bradycardia and hypotension. These effects are generally temporary and can be successfully treated with atropine or ephedrine and volume infusions
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Therefore, we plan to conduct this study to find the optimal and effective lower possible dose of dexmedetomidine in combination with topical spray and local blocks of airway for awake orotracheal fibre-optic intubation
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing elective head and neck cancer surgeries where difficult intubation is anticipated due to limited mouth opening (less than two fingers), restriction of neck mobility, lack of space for laryngoscopy, Patients willing to give consent , ASA group I and II.
排除标准
- •Patient included in other studies, non cooperative patient, history of allergy to any study medication, pre existing bleeding and coagulation disorder, patients having bradycardia and heart block, pregnancy, alcohol/drug abuse.
结局指标
主要结局
Mean Ramsay sedation score, percentage of intubation score, percentage of airway obstruction score, mean intubation Comfort score, percentage post intubation score
时间窗: Baseline, at end of drug infusion, before starting fibrescopy
次要结局
- Mean of Haemodynamic parameters (HR,MAP,SpO2), percentage of episodes of desaturation,hypotension,bradycardia. Percentage of ability to recall memory of endoscopy and intubation.(Baseline,at end of drug infusion, before fibrescopy, 1min after intubation, 3 min after intubation.)
研究者
Dr Saloni Jain
SMS Medical College and attached hospitals