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CTRI Number  CTRI/2016/10/007374 [Registered on: 17/10/2016] Trial Registered Retrospectively
Last Modified On: 21/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two different supraglottic airway devices for laproscopic hernioplasty 
Scientific Title of Study   Comparison of I-gel vs LMA Proseal as airway for laproscopic hernioplasty 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
062/15  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Richa Gupta 
Designation  Resident Doctor 
Affiliation  government medical collage, surat 
Address  206,north view building, laughing buddha circle, near sneh-milan garden, near kadampalli, nanpura, surat.
department of anaesthesiology, new civil hospital, government medical collage, majura gate, surat.
Surat
GUJARAT
395001
India 
Phone  9099006849  
Fax    
Email  richa.gmcs@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neeta Kavishvar 
Designation  Head of Department 
Affiliation  government medical collage, surat 
Address  flat 2/B, Prarthna apartment, ravishankar sankul, bhatar char rasta, surat. 395017
department of anaesthesiology, new civil hospital, government medical collage, majura gate, surat.
Surat
GUJARAT
395017
India 
Phone  9825615264  
Fax    
Email  neeta_kavishvar@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Richa Gupta 
Designation  Resident Doctor 
Affiliation  government medical collage, surat 
Address  206,north view building, laughing buddha circle, near sneh-milan garden, near kadampalli, nanpura, surat.
department of anaesthesiology, new civil hospital, government medical collage, majura gate, surat.
Surat
GUJARAT
395001
India 
Phone  9099006849  
Fax    
Email  richa.gmcs@gmail.com  
 
Source of Monetary or Material Support  
New Civil Hospital, Surat 
 
Primary Sponsor  
Name  Dr Richa Gupta 
Address  206,north view building, laughing buddha circle, near sneh-milan garden, near kadampalli,nanpura, surat 395001 
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 Richa Gupta  new civil hospital, surat  Surgery OT,new civil hospital, government medical collage, majura gate, surat,395001
Surat
GUJARAT 
9099006849

richa.gmcs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
human research ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients with hernia.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  I-gel  I-gel is a type of supraglottic airway device 
Comparator Agent  Proseal LMA  Proseal LMA is a type of supraglottic airway device 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  body weight 40-60kgs 
 
ExclusionCriteria 
Details  Obese patients,known difficult airway, mouth opening <2.5 fingers, cervical spine disease, patients prone to aspiration such as hiatus hernia and GERD and emergency surgeries. Patients with systemic illness.Those patients who does not give consent to be part of the study are excluded from the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
a)To compare two supraglottic devices I gel vs LMA Proseal in terms of respiratory mechanics during positive pressure ventilation in laproscopic hernioplasty

b)To study and compare two devices for ease of insertion and effectiveness of insertion.
 
peak airway pressure, inhaled tidal volume, exhaled tidal volume, leak, minute ventilation, etco2 will be recorded 10 mins after placement of device, 10 mins after carboperitonium, 10mins after release of co2. 
 
Secondary Outcome  
Outcome  TimePoints 
a)To study the hemodynamic parameters with the above two devices in laproscopic hernia


b)Study adverse events in the group in form of trauma to airway and post operative sore throat and other complications.
 
hemodynamic parameters at 1, 3,5,7,10 and 15 mins after device insertion, and after removal of device.

immediate post-operative complications and delayed post-operative complications (after 12 hrs of surgery). 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/07/2015 
Date of Study Completion (India) 10/08/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
1.Comparision of clinical performance of the Igel with LMA proseal By- Gaurav Chauhan. Pavan Nayar, Anita Seth, Kapil Gupta, Mamta Panwar, Nidhi Agrawal. Department of Anesthesia and Intensive Care, Sadarjang Hospital, New Delhi, India Journal of anaesthesiology clinical pharmacology/jan-mar13/vol29/issue1/pg56-60 2.Comparison of Clinical Performance of I-Gelâ„¢ with LMA—Prosealâ„¢ in Elective Surgeries Ishwar Singh,1 Monika Gupta,2 and Mansi Tandon3 Department of Anesthesiology, Jaipur Golden Hospital, New Delhi. Indian J Anaesth. Jun 2009; 53(3): 302–305  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is a prospective randomized controlled study which will be conducted on 60 patients who are within the decided inclusion criterias. 60 patients will be then randomly allotted in two groups GROUP I and GROUP P of 30 each by computer based randomized system. Patients will be premedicated with inj glycopyrrolate 0.2mg i.m, in fortwin 0.6mg/kg i.m. In operation theatre, inj midazolam 1mg i.v will be given and basal reading of HR, SBP, DBP, Oxygen saturation, will be noted. After induction with inj propofol 3mg/kg i.v , with loss of eyelash reflex, inj rocuronium 0.9mg/kg will be administered. After mask ventilation for 1 minute appropriate size airway device according to the group which patient belongs,  will be inserted. Effective ventilation with the device will be defined as bilateral equal chest movements and normal capnograph. Hemodynamic readings will be taken at 1,3,5,7,10,15minutes after insertion of device . Insertion attempts and ease of  insertion will be noted. More than two intertions attempts will be considered as a failure and that patient will be excluded from the study and patient will be intubated conventionally.  IPPV will be given to maintain EtCO2 between 30-45mm hg. Patient will be maintained on oxygen, nitrous oxide, isoflurane, and intermittent inj vecuronium iv. Ryle’s tube will be inserted through the device and its ease of insertion and number of attempts will be noted. Oxygen saturation, EtCO2 , airway pressure, inhaled tidal volume, exhaled tidal volume, minute ventilation is noted before, and after ten minutes of CO2 insuffation and 10minutes after release of CO2. After surgery patient will be reversed with inj neostigmine 0.05mg/kg i.v and inj. Glycopyrrolate 0.008mg/kg i.v. After patient is conscious and follows verbal command patient will be transferred to post operative recovery room.

Complications such as incidence of cough, laryngospasm, blood on device, lip and dental trauma will be noted.

Each patient will be questioned after 12hrs of surgery regarding sore throat, dysphagia, dysphonia, numbness over tongue or oropharynx.

Mean and SD will be calculated and data will be analysed using paired t-test using EPI software. 
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