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CTRI Number  CTRI/2021/07/034527 [Registered on: 02/07/2021] Trial Registered Prospectively
Last Modified On: 30/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison of two different types of second generation LMAs in ear surgeries under TIVA 
Scientific Title of Study   Comparison of ease of insertion of two different types of second generation Laryngeal mask airways in aural surgeries under total intravenous anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nupur Aggarwal 
Designation  Pg 1st year Anaesthesia 
Affiliation  School of medical sciences & research 
Address  Department of Anaesthesiology School of Medical Sciences & Research Sharda University
plot no 32,34, knowledge park 3, greater noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9654145106  
Fax    
Email  NUPUR.AGGARWAL@SHARDA.AC.IN  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aarti Srivastava 
Designation  Professor & Head of Department 
Affiliation  School of medical sciences & research 
Address  Department of Anaesthesiology School of Medical Sciences & Research Sharda University
plot no 32,34, knowledge park 3, greater noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9811966766  
Fax    
Email  aarti.srivastava@sharda.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Nupur Aggarwal 
Designation  Pg 1st year Anaesthesia 
Affiliation  School of medical sciences & research 
Address  Department of Anaesthesiology School of Medical Sciences & Research Sharda University
plot no 32,34, knowledge park 3, greater noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9654145106  
Fax    
Email  NUPUR.AGGARWAL@SHARDA.AC.IN  
 
Source of Monetary or Material Support  
Sharda hospital 
 
Primary Sponsor  
Name  Sharda hospital 
Address  plot no 32, 34, knowledge park 3, greater noida, uttar pradesh- 201310 
Type of Sponsor  Private 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 
Nupur Aggarwal  Sharda hospital School of Medical Sciences & Research   Department of Anaesthesiology, 2ND floor, B block
Gautam Buddha Nagar
UTTAR PRADESH 
09654145106

NUPUR.AGGARWAL@SHARDA.AC.IN 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  i gel  Second generation laryngeal mask airway( iGel) will be used to see- 1.Ease of insertion of the device 2.Insertion time- time between picking up the device and obtaining an effective airway 3.Attempts of insertion - three insertion attempts will be allowed before a failure of insertion is recorded. Estimated time required for insertion of Igel is less than 45 seconds  
Comparator Agent  Proseal  Second generation laryngeal mask airway( Proseal) will be used to see- 1.Ease of insertion of the device 2.Insertion time- time between picking up the device and obtaining an effective airway 3.Attempts of insertion - three insertion attempts will be allowed before a failure of insertion is recorded. Estimated time required for insertion of Proseal is less than 60 seconds 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. ASA grade 1 & 2
2. Age 18-45 years
3. Patients scheduled for elective ear surgery with either I-gel or PLMA as airway device
 
 
ExclusionCriteria 
Details  1. Patients with respiratory tract infection
2. Difficult airway (mouth opening <2cm, Mallampati class 4, limited neck extension, history of previous difficult intubation)
3. Known pulmonary and cardiovascular diseases
4. Risk of aspiration (full stomach, hiatus hernia, GERD)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare ease of insertion and time taken for insertion of I gel v/s Proseal LMA.  5 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
a) To record the hemodynamic changes.
b) To check for postoperative sore throat
c) To check for postoperative nausea and vomiting.
 
1 minute before induction (baseline), just before LMA insertion, 5 minute after LMA insertion and 10 minute after LMA insertion
Patients will be observed for 1 hour after extubation in post- operative care unit. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   05/07/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Inhalational anaesthetic agents have remained the main stay in the conduct of anaesthesia. This is primarily because of their ability to produce surgical anaesthesia without the need of hepatic or renal metabolism for their elimination. However, many side effects of inhalational agents have been noticed like sensitization of myocardium by halothane and nephrotoxicity of methoxyflurane and operation theatre pollution. In addition, nitrous oxide which is used as a carrier gas with inhalational agents, can cause ozone layer depletion. To overcome these side effects of inhalational anaesthetic agents and nitrous oxide; an alternative technique was thought of. One such alternative technique is total intravenous anaesthesia (TIVA) where in there is total avoidance of nitrous oxide and inhalational anaesthetic agent and operative anaesthetic depth is maintained by continuous infusion of intravenous anaesthetic agent.  

Advantages of TIVA are1

1. Simplicity of technique and readily acceptance by patients.

2. Produces high quality anaesthetic condition

3. Minimal cardiovascular depression.

4. Avoidance of deleterious effect of volatile anaesthetics eg., hepatotoxicity

5. Speedy and complete recovery.

6. Avoids malignant hyperthermia.

7. Reduction in theatre pollution

8. Avoids distention of air-filled spaces within patient’s body, which is due to nitrous oxide.

9. Avoids postoperative diffusion hypoxemia

10. Decreases the incidence of PONV

 

Propofol is currently the most suitable anaesthetic agent for total intravenous anaesthesia (TIVA); it allows for rapid changes in anaesthetic depth and a rapid, clear-headed recovery. Also, low context sensitive half-time 2 makes it theoretically the best available agent for long procedures under TIVA.

Furthermore, propofol attenuates airway reflexes to the extent that the laryngeal mask airway (LMA) may be positioned easily without neuromuscular block 3

The Laryngeal Mask Airway (LMA) is a supraglottic airway device designed to maintain a clear airway, which sits outside of and creates a seal around the larynx. Compared with the face mask, the LMA allows for a more "handsfree approach" to airway management 4. In difficult airway management, LMA can bypass obstruction at supraglottic level and allow rescue oxygenation and ventilation, provided that mouth opening is sufficient 5.

The LMA-ProSeal is a second generation supraglottic airway device with modified cuff and drainage tube, designed for better seal with both the respiratory and gastrointestinal tracts, not compromising the access to the alimentary tract. 6,7,8

The I-gel airway is a new supraglottic airway device with a non-inflatable cuff, composed of soft gel like, transparent thermoplastic elastomer. It is designed to achieve a mirror impression of pharyngeal and laryngeal structures and to provide a peri laryngeal seal without cuff inflation. A drain tube is placed lateral to the airway tube, which allows insertion of gastric tube.9 It has the potential advantages of easier insertion, minimal risk of tissue compression, stability after insertion and an inbuilt bite block.10

Patients undergoing surgery under general anesthesia require an adequate level of hypnosis to protect them from stress of awareness and recall of traumatic interventions. Conventionally, the hypnotic state is assessed by observing changes in the respiratory and cardiovascular system.

However, in recent times, the hypnotic state is assessed by monitoring the electrical activity of the brain which directly indicates the depth of anesthesia. This has been made possible by the introduction of newer and more sophisticated delivery system for total intravenous anesthesia (TIVA) and the Bispectral index monitor, which allows a computed analysis of real time EEG to assess the depth of anesthesia continuously.

 
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