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CTRI Number  CTRI/2025/11/097745 [Registered on: 20/11/2025] Trial Registered Prospectively
Last Modified On: 20/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   to compare the effectiveness of two airway devices which goes into the throat of a patient undergoing general anaesthesia for various parameters like ease of insertion, time to insert and any post operative airway issues  
Scientific Title of Study   Comparison of clinical effectiveness based on SGD-PF score of LMA Block buster vs LMA Fastrach in adult patients undergoing elective surgeries under general anaesthesia. A prospective,randomized trial 
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 Inderjit Kasan 
Designation  DNB Junior resident 
Affiliation  Dr B R Ambedkar State Institute of Medical Sciences, Mohali  
Address  Department of Anaesthesia, Dr B R Ambedkar State Institute of Medical Sciences, Mohali

Rupnagar
PUNJAB
160055
India 
Phone  8906000070  
Fax    
Email  drinderjitkasana@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Puja Saxena 
Designation  Professor and Head 
Affiliation  Dr B R Ambedkar State Institute of Medical Sciences, Mohali  
Address  Department of Anaesthesia, Dr B R Ambedkar State Institute of Medical Sciences, Mohali

Rupnagar
PUNJAB
160055
India 
Phone  9780012436  
Fax    
Email  pujasaxena36@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Inderjit Kasan 
Designation  DNB Junior resident 
Affiliation  Dr B R Ambedkar State Institute of Medical Sciences, Mohali  
Address  Department of Anaesthesia, Dr B R Ambedkar State Institute of Medical Sciences, Mohali


PUNJAB
160055
India 
Phone  8906000070  
Fax    
Email  drinderjitkasana@gmail.com  
 
Source of Monetary or Material Support  
Dr B R Ambedkar State Institute of Medical Sciences, Mohali. Punjab.India 
 
Primary Sponsor  
Name  Dr B R Ambedkar State Institute of Medical Sciences, Mohali  
Address  Dept of Anaesthesia, Dr B R Ambedkar State Institute of Medical Sciences, Mohali. Punjab. India  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Inderjit Kasana  Dr B R Ambedkar State Institute of Medical Sciences, Mohali   Department of Anaesthesia, Dr B R Ambedkar State Institute of Medical Sciences, Sector 56, Mohali
Rupnagar
PUNJAB 		 8906000070

drinderjitkasana@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee- Human research (IEC-HR)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group Blockbuster  Will receive LMA Blockbuster as an intubation conduit 
Comparator Agent  Group Fastrach  Will recieve LMA Fastrach as an intubation conduit 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients undergoing elective surgeries under general anaesthesia 
 
ExclusionCriteria 
Details  1. Patient with pre operative sore throat or upper respiratory tract infection.
2. Patients with head and neck surgery involving airway
3. Anticipated Difficult airway
4. Surgeries in prone position
5. Pregnant patients. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effectiveness of LMA blockbuster vs LMA Fastrach
based on SGD PF score in adult patients undergoing elective surgery under general anaesthesia 		 Baseline, 0,5,10,15,30,45,60,90,120,180 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the hemodynamic changes in both the groups  0,5,10,15,30,45,60,90,120 minutes 
To compare the severity of hoarseness, foreign body sensation during rest and at swallowing  0,2,4,6,10,12,24 hours 
To compare the severity of cough in both the groups in post operative period  0,2,4,6,12,24 hours 
To compare the incidence of post operative nausea, vomiting in the post operative period in both the
groups 		 0,2,4,6,12,24 hours 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   Phase 4 
Date of First Enrollment (India)   01/12/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drinderjitkasana@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 30-11-2040?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
Airway management is of prime importance in anaesthesia. For it, endotracheal tube and Laryngeal Mask
Airway (LMA) are routinely used. LMA has two parts, a simple breathing tube and a mask. The mask at the
laryngeal end of the tube aligns against the glottis and provides the channel of ventilation. There have been
modifications in the basic design of the LMA to incorporate gastric drainage channel and some devices are
also equipped with a channel for intubation to secure airway by guiding endotracheal tube (ETT) through
it
This will be a prospective randomized study. A total of 200 patients undergoing
elective surgery under general anaesthesia will be randomly allocated to two groups of 100 (Group
BB and Group FT) patients each, using computer generated random number table
(www.randomization.com). 
Group BB (n=100): will Receive LMA Blockbuster as an intubation conduitGroup FT(n=100): will receive LMA Fastrach as an intubation conduit
 
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