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CTRI Number  CTRI/2024/09/074300 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 22/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing four devices for managing air passage during operations using laparoscopy 
Scientific Title of Study   A randomised comparison of LMA proseal, Ambu auragain, baska mask and LMA protector for airway management in laparoscopic surgeries 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ayur Verma 
Designation  Junior resident  
Affiliation  King Georges Medical University 
Address  Room No.1, Department of Anaesthesiology, King Georges Medical University Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9899807409  
Fax    
Email  ayur1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Raman 
Designation  Additional Pofessor 
Affiliation  King Georges Medical University 
Address  Room No.1, Department of Anaesthesiology, King Georges Medical University Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9452526270  
Fax    
Email  ramanrajesh83@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajesh Raman 
Designation  Additional Pofessor 
Affiliation  King Georges Medical University 
Address  Room No.1, Department of Anaesthesiology, King Georges Medical University Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9452526270  
Fax    
Email  ramanrajesh83@gmail.com  
 
Source of Monetary or Material Support  
King Georges Medical University, Chowk, Lucknow, Uttar Pradesh, India, Pin code-226003 
 
Primary Sponsor  
Name  Ayur Verma 
Address  Department of Anaesthesiology, King Georges Medical University, Chowk, Lucknow, Uttar Pradesh, India, Pin code-226003 
Type of Sponsor  Other [self] 
 
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 Ayur Verma  King Georges Medical University,  Room No 1, Department of Anesthesiology Chowk, Lucknow, Uttar Pradesh, India, Pin code-226003
Lucknow
UTTAR PRADESH 		 9899807409

ayur1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, King Geroge Medical University  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 
Comparator Agent  AMBU auragain  AMBU auragain will be inserted after induction of anaesthesia 
Comparator Agent  Baska Mask   Baska Mask will be inserted after induction of anesthesia. 
Intervention  LMA proseal  LMA proseal will be inserted after induction of anaesthesia 
Comparator Agent  LMA protector  LMA protector will be inserted after induction of anesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical status 1 and 2.
Elective laparoscopic surgeries of anticipated duration less than 2 hours  
 
ExclusionCriteria 
Details  Anticipated difficult airway.
Pregnancy.
Respiratory and cardiovascular disease.
Refusal of consent.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Oropharyngeal leak pressure   20 mins after pneumoperitoneum 
 
Secondary Outcome  
Outcome  TimePoints 
time taken for insertion  immediately after device insertion 
Fibreoptic view of glottis  Intraoperatively after confirmation of adequate ventilation 
Hemodynamic changes with mean arterial pressure and heart rate.  1. baseline (before induction of anesthesia)
2. after induction of anesthesia
3. after device placement
4. after removal of device 
ease of insertion  Immediately after device placement 
Success rate of insertion  immediately after device insertion 
Oropharyngeal leak pressure  after confirmation of correct SAD placement 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   20/10/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

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

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ramanrajesh83@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 01-02-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

AIM: A Randomized Comparison of LMA Proseal, Ambu Auragain, Baska Mask and LMA Protector for airway management in laparoscopic surgeries

 

PRIMARY OBJECTIVE:  

§  To compare oropharyngeal leak pressure of LMA Proseal, Ambu Auragain, LMA Protector and Baska mask, when managing airway in laparoscopic surgeries after pneumoperitoneum formation..

 

SECONDARY OBJECTIVES:

Following are the secondary objectives-

To compare time taken for insertion of LMA proseal, Ambu Auragain, LMA Protector and Baska mask, when managing airway in laproscopic surgery.

To compare number of attempts of LMA proseal, Ambu Auragain, LMA Protector and Baska mask, when managing airway in laproscopic surgery.

To compare fiber optic view of glottis through LMA proseal, Ambu Auragain, LMA Protector and Baska mask, when managing airway in laproscopic surgery.

To compare the hemodynamic changes which are mean arterial pressure and heart rate at different duration of time which are- a. baseline hemodynamics, b. after induction hemodynamics c. after device placement hemodynamics, and d. after removal hemodynamics.

To compare Ease of SAD insertion of LMA Proseal, Ambu Auragain, LMA Protector and Baska mask, when managing airway in laproscopic surgery.

To compare success rate of insertion of LMA Proseal, Ambu Auragain, LMA Protector and Baska mask, when managing airway in laproscopic surgery.

§  To compare Oropharyngeal leak pressure before pneumoperitoneum formation of LMA Proseal, Ambu Auragain, LMA Protector and Baska mask, when managing airway in laproscopic surgery.

To compare complication (including but not limited to sore throat, blood on device, cough etc) between LMA Proseal, Ambu Auragain, LMA Protector and Baska mask, when managing airway in laproscopic surgery.

To compare saturation at different duration of time which are- a. baseline hemodynamics, b. after induction hemodynamics c. after device placement hemodynamics, and d. after removal hemodynamics.

 
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