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CTRI Number  CTRI/2024/10/074678 [Registered on: 03/10/2024] Trial Registered Prospectively
Last Modified On: 01/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of supraglottic airway devices in laparoscopic cholecystectomy patients  
Scientific Title of Study   Comparision of efficacy of Air Q laryngeal mask airway and Baska mask in patients undergoing laparoscopic cholecystectomy: A prospective randomized clinical study  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arvind Khare 
Designation  Senior Professor 
Affiliation  Jawahar lal Nehru medical college , Ajmer , Rajasthan  
Address  Department of anaesthesiology, new OT, first floor, JLN hospital, Kalabagh, Ajmer, Rajasthan

Ajmer
RAJASTHAN
305001
India 
Phone  9414306114  
Fax    
Email  arvindkhare68@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arvind Khare 
Designation  Senior Professor 
Affiliation  Jawahar lal Nehru medical college , Ajmer , Rajasthan  
Address  Department of anaesthesiology, new OT, first floor, JLN hospital, Kalabagh, Ajmer, Rajasthan

Ajmer
RAJASTHAN
305001
India 
Phone  9414306114  
Fax    
Email  arvindkhare68@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arvind Khare 
Designation  Senior Professor 
Affiliation  Jawahar lal Nehru medical college , Ajmer , Rajasthan  
Address  Department of anaesthesiology, new OT, first floor, JLN hospital, Kalabagh, Ajmer, Rajasthan

Ajmer
RAJASTHAN
305001
India 
Phone  9414306114  
Fax    
Email  arvindkhare68@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiology, new OT, 1st floor, JLN hospital, Kalabagh, Ajmer, Rajasthan 305001 
 
Primary Sponsor  
Name  JLN medical college  
Address  New OT, first floor, JLN hospital, Kalabagh, Ajmer, Rajasthan 305001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajeev Jain  JLN medical college and hospital  Department of anaesthesiology, new OT, first floor, JLN hospital, Kalabagh, Ajmer, Rajasthan 305001
Ajmer
RAJASTHAN 
9680110086

drrajeevjain8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethecal committee Jawarlal Nehru medical college, Ajmer  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Air Q LMA  The air-Q ® Intubating Laryngeal Airway (air-Q; Mercury Medical, Clearwater, FL, USA) is a new supraglottic airway device (SAD) intended for use as a primary airway as well as an aid for tracheal intubation in situations of anticipated or unanticipated difficult airways. Its design includes a large airway tube inner diameter (ID), a short airway tube length and a tethered, removable standard 15- mm circuit adapter. These features enable direct insertion of larger tracheal tubes (up to 7.5 and 8.5 mm IDs for air-Q sizes 3.5 and 4.5, respectively) through the 7 airway tube and reduce the tracheal tube length requirements imposed by some SADs to ensure tracheal tube cuff placement below the level of the vocal cords.[ 
Comparator Agent  Baska mask  Baska Mask which incorporates the features of 2nd generation LMA with additional feature that provide a higher seal pressure than other LMAs as during intermittent positive pressure ventilation (IPPV) the seal apposes to the glottis incrementally to augment seal pressure with increasing airway pressure. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age 18 to 60years. ASA grade I & II. BMI less then 30. Under going laparoscopic cholecystectomy under general anaesthesia. Surgery lasting up to 90 minutes. 
 
ExclusionCriteria 
Details  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  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Oropharyngeal leak pressure of air Q LMA and Baska mask   Grading point system 
 
Secondary Outcome  
Outcome  TimePoints 
1 Number of attempts for successful insertion of Air Q LMA and Buska mask
2 Time taken for successful insertion of the devices
3 Ease of successful insertion of orogastric tube through the drain tube of both the devices
4 Flexible fiberoptic visualization of glottic through the airway tube of both the devices
5 Hemodynamic variables heart rate, systolic BP, diastolic BP, mean arterial pressure
6 Peak airway pressure pre and post pneumoperitonium following insetion of both the devices.
7 Incidence of postoperative adverse events between Air Q LMA and Baska mask like-
Blood staining on device
Sore throat
Hoarseness of voice
Aspiration
Regurgitation 
Subjective scale and grading point system 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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
 
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