A randomized clinical comparative study to observe intravenous fentanyl versus Topical lignocaine for Prosealâ„¢ laryngeal mask airway insertion with propofol induction.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proseal LMA insertion conditions.
研究概览
简要总结
To compare the effect of topical lignocaine versus intravenous Fentanyl for proseal LMA insution, took sample size of 60 prients, with 30 patients in each group.
Group A patients will recieve Normal saline spray in Posterior Pharyngeal wall & injection fentanyl 2mcg/kg intravenously.
Group B patients will recieve Topical lignocaine spray in posterior pharyngeal & Normal saline intravenously.
Then patients will be induced by Inj Propofol 2mg/kg. & PLMA will be inserted.
Occurrence of coughing, gagging , laryngospasm or body movement will be recorded. If these phenomenon are absent it will be optimal proseal LMA insertion . If these are present and proseal LMA could not be inserted in its first attempt it is not optimal proseal LMA insertion.
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
- •1 Able to give consent for procedure 2 ASA Grade first & second 3 Age group 18- 60 yrs.
- •4 Mallampati grade first & second 5 Undergoing general anaesthesia for elective surgeries which were less then 90 mins duration.
- •6 Fasting more then 8 hours 7 BMI less then 30.
排除标准
- •1 Patient refusals 2 ASA grade 3,4,5 3 Mouth opening less then 2.5 centimeter 4 Thyromental distance less then 4cm 5 Patients with poor lung compliance 6 Patients with cardiac disease, renal disease and hepatic disease 7 Known anatomical laryngotracheal anomaly 8 Undergoing emergency surgery 9 Fasting status doubtful 10 BMI more then 30 11 H/O of GERD.
结局指标
主要结局
Proseal LMA insertion conditions.
时间窗: Baseline to 5 minute
次要结局
- -Incidents of side effects (such as coughing, gagging, laryngospasm,(body movement, and apnea).)
研究者
Dr Maina Singh
JLN medical college and hospital, Ajmer