Comparison of efficacy of Intravenous Versus Nebulized Ketamine-Dexmedetomidine Combination (Ketodex) in Awake Fiberoptic Intubation
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- 1. Difference in time (sec) taken to intubate the patients during Awake Fiberoptic Intubation in both the groups
研究概览
简要总结
Awake fiber-optic intubation (AFOI) is considered as the standard option in dealing with the cases amongst anticipated difficult airway. Proper conscious sedation is paramount to increase the tolerability of the intubation and its success.
An ideal sedative agent should be the one that provides better comfort and compliance ie, patientcooperation while maintaining haemodynamic stability and spontaneous ventilation,when being awake during the procedure. It may be difficult to choose appropriate sedative drugs due to their depressant effects on respiration.
Intravenous is the most common route used for this purpose, However, the nebulized route is an attractive alternative as it can potentially avoid systemic side effects.
Dexmedetomidine, an α2-adrenoreceptor agonist, is a very useful drug for fiberoptic intubation as it can produce sedation, analgesia and anxiolysis without causing respiratory depression. In addition, it can also cause xerostomia( decreased salivation) which can be utilized to counter act excessive salivation caused by the Ketamine. These two effects make dexmedetomidine highly desirable for awake fiberoptic nasotracheal intubation.(4) Unlike patients sedated with propofol, patients receiving dexmedetomidine are easily arousable without expressing irritation(5). The relative sympatholysis achieved during dexmedetomidine infusions is an additional benefit in a procedure that may lead to elevations of heart rate (HR) and blood pressure(6)
Ketamine is a NMDA receptor antagonist,which provides sedation and analgesia along with its sympatho mimetic effects, at the same time causing excessive salivation or secretions.
Hence combination of these two( ketamine & dexmeditomidine) can counteract side effects of each other, which can be utilised in AFOB.
Low doses of ketamine added to dexmedetomidine provide an additional analgesic effect and assist avoid bradycardia and hypotension caused by dexmedetomidine,while dexmedetomidine attenuates the unfavourable rise in airway secretion brought by ketamine.
Combining Ketamine and Dexmedetomidine will result in more steady hemodynamic response, greater sedation and easier intubation because Ketamine and Dexmedetomidine have opposing effects on cardiac autonomic receptors and the central nervous system. Therefore, this study aims to compare the efficacy of Intravenous Versus Nebulized Ketamine-Dexmedetomidine Combination (Ketodex) in Awake Fiberoptic 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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with the ASA physical status I or II according to the American Society of Anesthesiologists (ASA).
排除标准
- •Patients who refuse or uncooperative such as those with mental retardation, lack of communication, blindness, and deafness were excluded from the study.
- •Patients who had coagulation disorders, respiratory or pulmonary disorders, pregnancy or full stomach, increased intracranial pressure or intraocular pressure, and emergency surgeries or allergy to the drug used in the study or with risk for regurgitation–aspiration were excluded from the study​.
结局指标
主要结局
1. Difference in time (sec) taken to intubate the patients during Awake Fiberoptic Intubation in both the groups
时间窗: At the time of intubation
2. Difference in the ease of intubation with the help of intubation score (vocal cord movement, limb movement, and cough) at the time of entry of tip of endotracheal tube through the glottis.​
时间窗: At the time of intubation
次要结局
- 1.Difference in hemodynamic variables (Heart rate (HR), mean arterial pressure (MAP), and peripheral oxygen saturation (SpO2) in both the groups after starting the infusion every two minutes for 10 minutes.(2. Difference in Post-operative Patient satisfaction score & adverse effects after 24 hours post extubation)
研究者
Dr Nabeeh N
AIIMS Bhopal