Randomized Double Blind Study To Evaluate The Comparison Of Ease Of Insertion Of Laryngeal Mask Airway In Children With Ketamine - Propofol And Fentanyl – Propofol.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1 TO compare and evaluate the ease of insertion for laryngeal mask airway with injection ketamine propofol and fentanyl propofol
研究概览
简要总结
LMA has become increasingly popular as an alternative for both endotracheal intubation and face mask ventilation as it induces fewer hemodynamic fluctuations.
the present study aims to compare the ease of LMA insertion and hemodynamic stability in KETAMINE - PROPOFOL versus FENTANYL - PROPOFOL IN CHILDREN
80 patients of age between 3 - 12 years of either sex and ASA grade 1 & 2 will be randmoly divided into two groups of 40 patients each . group PK will receive inj ketamine followed by induction with Inj propofol .
Group PF will receive Inj Fentanyl followed by Inj Propofol. Both the group will be compared for the ease of LMA insertion on the basis of 6 variables like head/limb movement, coughing / gagging, swallowing, resistance to mouth opening, resistance to insertion, laryngospasm . Number of attempts of LMA insertion will be noted. Hemodynamic parameters like BP, MAP.HR, RR , SpO2 will be noted at baseline, pre induction, pre LMA INSERTION, 1 MINUTE, 3 MINUTES, 5 MINUTES POST INSERTION. Any complications if any like sore throat, coughing, laryngospasm, hoarsness of voice, lacrimation, blood stain on LMA device will be noted during removal and during recovery
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
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1 ASA grade 1 & 2 2 age 3 to 12 yrs 3 elective surgery of duration less than one hour.
排除标准
- •1 ASA 3 &4 2 patients at risk of aspiration 3 patient with airway abnormalities, anticipated difficult airway, pharyngeal pathology like abscesses, hematoma , tissue disruption 4 patient suffering from upper airway tract infection, reactive airway disease, asthmatic 5 seizure disorder , neuromuscular diseases 6 known egg allergy 7 patients giving refusal to participate in study 8 patients allergic to study drug 9 more than 3 failed attempts of LMA insertion in the study.
结局指标
主要结局
1 TO compare and evaluate the ease of insertion for laryngeal mask airway with injection ketamine propofol and fentanyl propofol
时间窗: LMA insertion ease NOTED AT TIME OF insertion of LMA | hEMODYNAMIC PARAMETERS will be observed at baseline, pre induction, pre LMA, 1 minute , 3minute and 5 minutes post LMA insertion
2 Number of attempts of LMA insertion.
时间窗: LMA insertion ease NOTED AT TIME OF insertion of LMA | hEMODYNAMIC PARAMETERS will be observed at baseline, pre induction, pre LMA, 1 minute , 3minute and 5 minutes post LMA insertion
3 to compare the effect on hemodynamic parameters within the two groups
时间窗: LMA insertion ease NOTED AT TIME OF insertion of LMA | hEMODYNAMIC PARAMETERS will be observed at baseline, pre induction, pre LMA, 1 minute , 3minute and 5 minutes post LMA insertion
次要结局
- 1 to compare incidence of pharyngo laryngeal morbidity like cough vomiting laryngospasm blood stain on(LMA during removal)
研究者
DR KAMAL JYOTI KASHYAP
Government medical college amritsar