跳至主要内容
临床试验/CTRI/2024/11/076331
CTRI/2024/11/076331尚未招募4 期

Comparison of efficacy of Blockbuster laryngeal mask airway and Endotracheal tube in securing airway in women undergoing elective gynaecological laparoscopic surgeries- A randomized comparative study

Dr. S.N. Medical College Jodhpur1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年12月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Comparing the variability in hemodynamic parameters(BP,HR,MAP) during blockbuster LMA insertion with endotracheal tube insertion

研究概览

简要总结

The aim of the study is to compare the  efficacy of Blockbuster LMA with Endotracheal tube in securing airway in women undergoing elective gynaecological laparoscopic surgeries

Primary objective- To compare the variability in hemodynamic parameters(BP.HR,MAP) with insertion of blockbuster LMA and endotracheal tube.

secondary objectives - To compare the adequacy of ventilation(SPO2,ETCO2,RR,Peak airway pressure and tidal volume) , number of attempts and duration of insertion of blockbuster LMA with endotracheal tube and finding out incidence of post operative side effects(cough, hoarseness of voice, sore throat) asssociated while using blockbuster LMA and endotracheal tube.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
Female

入选标准

  • adult women whose age is more than 18 years with BMI less than 30kg/m2 of ASA class 1 and 2 and MPG grade 1 and 2.

排除标准

  • Severe cardiovascular disease (known case of Hypertension, CAD, MI, Angina, CVA), cervical spine disease, MPG grade 3 and 4, Mouth opening less than 3 finger width, loose teeth, oral pathology, risk of aspiration(known case of GERD, hiatus hernia).

结局指标

主要结局

Comparing the variability in hemodynamic parameters(BP,HR,MAP) during blockbuster LMA insertion with endotracheal tube insertion

时间窗: From before induction of anaesthesia till 5 min after extubation

次要结局

  • comparing the adequacy of ventilation (spo2, RR, ETCO2, Peak airway pressure, tidal volume), number of attempts & duration of insertion of two devices & finding out the post operative complications(cough,hoarseness of voice, sore throat) associated with use of blockbuster LMA & Endotracheal tube(From 1 minute after intubation till 5 min after extubation)

研究者

发起方
Dr. S.N. Medical College Jodhpur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Ananta Lagwal

Dr. S.N. Medical College Jodhpur

研究点 (1)

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