Clinical comparison of nebulised versus intravenously administered dexmedetomidine for obtunding hemodynainic responses to laryngoscopy and intubation: a randomized double blind comparative study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome of the study will be to compare intravenous dexmedetomidine with nebulised dexmedetomidine as premedication for attenuation of laryngoscopic and intubation response.
研究概览
简要总结
Dexmedetomidine is well known to attenuate the laryngoscopic response when administered intravenous, however its adverse effects have limited its use. Various studies have been done to study effectiveness of intranasal dexmedetomidine. however there has been no mention of the comparison of side effects between the two routes. Studies with nebulization with dexmedetomidine are limited.
The proposed study intends to use a different route of administration(nebulization) to determine its efficacy in attenuation of laryngoscopic response with lesser incidence of adverse effects.
A human clinical study only can provide insight in to such issues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Elective surgeries under general anaesthesia Patients of either sex having age 18-55years Body weight 50 to 70 kgs American society of anaesthesiologists (ASA) physical status I – II Patient’s written and informed consent.
排除标准
- •Patient refusal for the anaesthetic technique.
- •Patients having mouth opening < 3 Cms or predicted difficult airway.
- •Any bleeding disorder or patient on anticoagulants History of allergy to study drug Patient belonging to ASA CLASS III, IV & V Patients on any sedatives, antipsychotics, antidepressants, anxiolytics or anticonvulsants and betablockers.
- •Patient with any nasal pathology like nasal ulcer, nasal polyp, nasal septum deviation.
- •Patients with difficult airway like cervical spine instability, facial fractures, partially obstructing laryngeal lesions (e.g., papilloma), craniofacial abnormalities, and temporo mandibular joint ankylosis.
- •Patient coming for emergency surgery Pregnant patients H/O Covid infection during last 3 months.
结局指标
主要结局
The primary outcome of the study will be to compare intravenous dexmedetomidine with nebulised dexmedetomidine as premedication for attenuation of laryngoscopic and intubation response.
时间窗: Vitals will be recorded on starting the study drugs and after every 5 minutes interval till the endotracheal tube is inserted. Also, vitals will be recorded immediately after intubation, 1,3 and 5 minutes after intubation thereafter every 5 minutes up to 30 minutes after insertion of endotracheal tube than at extubation.
次要结局
- The secondary outcome of the study will be to study and compare the sedation score and(to study and compare the complications encountered with the two routes)