Comparision of efficacy of Air Q laryngeal mask airway and Baska mask in patients undergoing laparoscopic cholecystectomy: A prospective randomized clinical study
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- JLN medical college
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Oropharyngeal leak pressure of air Q LMA and Baska mask
Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age 18 to 60years.
- •ASA grade I & II.
- •BMI less then
- •Under going laparoscopic cholecystectomy under general anaesthesia.
- •Surgery lasting up to 90 minutes.
Exclusion Criteria
- •ASA grade III and above.
- •Known difficult airway (with recent history upper respiratory tract infection, any obvious scar or mass or ulcer in neck, cleft lip/palate, adenotonsilar hypertrophy or lingual tonsils , obese syndromic, microganthia, congenital malformations involving respiratory tract, cervical spine disorder).
- •Mouth opening less then 2.5 cm .
- •With increase risk of aspiration of gastric contents (NBM status unknown, non fasted, gastrointestinal stricter or stenosis ).
- •Obesity BMI more then 30kg per meter square.
- •Negative patient consent.
- •Pregnant patient.
Outcomes
Primary Outcomes
Oropharyngeal leak pressure of air Q LMA and Baska mask
Time Frame: Grading point system
Secondary Outcomes
- 1 Number of attempts for successful insertion of Air Q LMA and Buska mask(2 Time taken for successful insertion of the devices)
Investigators
Dr Arvind Khare
Jawahar lal Nehru medical college , Ajmer , Rajasthan