Comparision of efficacy of Air Q laryngeal mask airway and Baska mask in patients undergoing laparoscopic cholecystectomy: A prospective randomized clinical study

Study title- Comparison of Efficacy of Air Q Laryngeal Mask Airway And Baska Mask In

Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomized Clinical

Study.

The study will be conducted in the Department of Anaesthesiology at JLN Medical college and

Associated Group of Hospitals, Ajmer. It is a hospital based Prospective, Randomized, Double

Blind, interventional study. To our knowledge, none of the study has compared the AIR Q

laryngeal mask airway & BASKA Mask till now so we. So, we decided to compare the safety

and efficacy of AIR Q laryngeal mask airway & BASKA Mask used in patients undergoing

elective laparoscopic cholecystectomy under general anaesthesia. Our primary objective will

be to compare the Oropharyngeal leak pressure of both devices and secondary objective will

be to compare number of attempts and time for successful insertion, ease of orogastric tube

(OGT) insertion, fibre optic visualization of glottis, haemodynamic, peak airway pressure

before and after pneumoperitoneum and complications at emergence and postoperatively.

A sample size of z=80 patients (n=40 in each group) will be estimated based on the previous

studies. This calculation will be deduced with an alpha error of 0.05 ,beta error of 0.20 and

power of 80% . The randomization will be done by opaque sealed envelope technique. After

obtaining the approval by ethical committee of the hospital and consent for general anaesthesia

will be taken from the patient Patients will be divided into two groups {Group A and Group B}

Preanesthetic evaluation will be done on previous day of surgery. Nil per oral status of at least

8 hours will be maintained. Premedication with tab Alprazolam 0.25 mg will be given on

previous night.

The frequency distribution of categorical data will be expressed as frequency count and

proportions. Continuous data will be expressed as mean +S.D. The significance of the

difference in proportion of cases will be inferred by chi square test or fishers exact test as

appropriate. Significant differences in the distribution of continuous data will be explored using

a student’s t test. 95% confidence interval around the point estimate will be reported. A ’P’ value

<0.05 will be considered significant. Categorically, the data analysis will be performed using

comprehensive statistical software platform SPSS 28.9 Windows including power meta-

analysis for functional data analogue. Other descriptive and inferential statistics may be used

as per data collected