EFFECT OF A SINGLE DOSE OF DEXMEDETOMIDINE ON EXTUBATION STRESS RESPONSE DURING ANAESTHETIC EMERGENCE.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- To assess and grade the severity of cough response at the time of extubation.
研究概览
简要总结
Endotracheal intubation is acommonly used mode of securing and isolating the airway in patients receivinggeneral anaesthesia. This is well tolerated when the patient is under adequateanaesthetic depth. However during emergence from general anaesthesia, anextubation stress response involving cough and adverse hemodynamic changes liketachycardia and hypertension has been identified and studied by variousauthors. (1-5) It is a significant and alarming event to the patientundergoing extubation and may cause various distressing complications likesurgical site re-bleeding, laryngospasm, hypertension, myocardial ischemia,oxygen desaturation, and violent behavior leading to injury to the patient,healthcare personnel and support staff. (1,2) It is desirable toavoid these unfavourable changes in patients during the time of extubationafter surgery.
Many pharmacologic agents like lignocaine, opioids, calcium channelblockers, esmolol, magnesium sulphate, propofol, etc. have been shown toattenuate these responses. (2,3,6) Dexmedetomidine is one such drug.It is an alpha-2 adrenergic receptor agonist. It finds use in the intensivecare setting for sedation of intubated patients and also in non-intubatedpatients for sedation in the perioperative period without depressing therespiratory drive. (2) It has been used in various doses rangingfrom 0.5mcg/kg to 1mcg/kg; with all doses providing adequate sedation but higherdoses increasing the risk of adverse hemodynamic outcomes. (4)It has also been found that a singlebolus administration of dexmedetomidine is associated with a lower incidence ofemergence delirium and pain scores as compared to a continuous infusion. (5)Thus, a single bolus dose of dexmedetomidine is an easy andstraightforward technique to reduce extubation stress response.
We intend to study the effect of asingle bolus dose of dexmedetomidine on the prevention of cough response at thetime of extubation. We also intend to study hemodynamic changes, adverse eventsand post-operative sedation over the course of emergence from generalanaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •ASA 1 and 2 patients aged between 18 and 60 years scheduled to undergo elective surgery under general anaesthesia with endotracheal intubation.
排除标准
- •1.Presence of an upper or lower respiratory tract infection.
- •2.Anticipated difficult airway.
- •3.Hepatic or renal dysfunction.
- •4.Poorly controlled hypertension.
- •5.Surgeries involving the upper airway.
结局指标
主要结局
To assess and grade the severity of cough response at the time of extubation.
时间窗: During anesthetic emergence from surgery. Half hour after administering the test and control agents on the day of intervention only. no long term follow up planned
次要结局
- To study: a) Hemodynamic response namely heart rate, systolic blood pressures, diastolic blood pressures and mean arterial pressures at the time of extubation. b) Adverse events i.e. desaturation (spo292%), breath holding spells (apnoea15 seconds), laryngospasm, postoperative nausea and vomiting (PONV) at the time of extubation. c) Post-operative sedation.(T0- basal parameters before anaesthetic induction; T1- before extubation; T2- after extubation; T3- 5 minutes after extubation. outcome is assessed on day of intervention only. no long term follow up is planned)