FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/04/024856 [Registered on: 25/04/2020] Trial Registered Retrospectively
Last Modified On: 25/04/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare two devices for managing airway during anaesthesia in adult patients undergoing laparoscopic gall bladder surgery. 
Scientific Title of Study   A comparative evaluation of clinical efficacy of two supraglottic airway devices in adult patients undergoing laparoscopic cholecystectomy under general 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 Anand Kumar Singh 
Designation  Post graduate 
Affiliation  Vardhman Mahavir Medical college and Safdarjung Hospital  
Address  Department of Anaesthesiology and Intensive care, Ground floor, main OT building, Vardhman Mahavir Medical college and Safdarjung Hospital New Delhi 110029 India New Delhi

New Delhi
DELHI
110029
India 
Phone  8860887856  
Fax    
Email  anandkumarsingh88@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nidhi Agarwal 
Designation  Consultant and Professor 
Affiliation   
Address  DDepartment of Anaesthesiology and Intensive care, Ground floor, main OT building, Vardhman Mahavir Medical college and Safdarjung Hospital New Delhi 110029 India New Delhi
ardhman Mahavir Medical college and Safdarjung Hospital
New Delhi
DELHI
110029
India 
Phone  9811030408  
Fax    
Email  nidhi.agrawal1970@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anand Kumar Singh 
Designation  Post graduate 
Affiliation  Vardhman Mahavir Medical college and Safdarjung Hospital  
Address  Department of Anaesthesiology and Intensive care, Ground floor, main OT building, Vardhman Mahavir Medical college and Safdarjung Hospital New Delhi 110029 India, New Delhi

New Delhi
DELHI
110029
India 
Phone  8860887856  
Fax    
Email  anandkumarsingh88@gmail.com  
 
Source of Monetary or Material Support  
Vardhman Mahavir medical college and Safdarjung Hospital new Delhi 110029 India 
 
Primary Sponsor  
Name  Vardhman Mahavir Medical college and Safdarjung Hospital 
Address  Department of Anaesthesiology and Intensive care, Ground floor, main OT building, Vardhman Mahavir Medical college and Safdarjung Hospital New Delhi 110029 India New Delhi  
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 Anand Kumar Singh  Vardhman Mahavir Medical college and Safdarjung Hospital  Department of Anaesthesiology and Intensive care, Ground floor, main OT building, Vardhman Mahavir Medical college and Safdarjung Hospital New Delhi 110029 New Delhi, India
New Delhi
DELHI 
8860887856

anandkumarsingh88@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  AGE more than 18YEARS ASA GRADE I AND II,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ambu Aura Gain  Patients in this group will be given general anaesthesia(pre medication with inj glycopyrolate 0.2mg iv, inj fentanyl@ 2microgram/kg iv,induced with inj propofol @2-3 mg/kg iv and inj vecuronium @ 0.1mg/kg iv) After indution, patient will be intubated using Ambu Aura Gain,only 3 attempts will be taken. If failed, airway will be secured with endotracheal intubation with a cuffed oropharyngeal tube of appropriate size.  
Intervention  i-gel   Patients in this group will be given general anaesthesia(pre medication with inj glycopyrolate 0.2mg iv,inj fentanyl@2 microgram/kg iv,induced with inj propofol @2-3mg/kg iv and inj vecuronium @0.1mg/kg iv) After inducton, patient will be intubated using i gel. only 3 attempts will be taken. If failed, airway will be secured with endotracheal intubation with a cuffed oropharyngeal tube of appropriate size. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)18 to 60 years of age
2)Either gender
3)American society of Anaesthesiologists (ASA) physical status I and II
4)Weight 30 to 70 kg,
 
 
ExclusionCriteria 
Details  1) Anticipated difficult airway including: Thyromental distance <6.5 cm, upper lip bite test more than grade 1, Mallampati class III and IV, restricted head and neck mobility, inter incisor gap <3.5cm , BMI>30 kg/m2
2) Cervical spine pathology
3) Operation time greater than 4 hours
4) High risk of aspiration ( gastroesophageal reflux disease)
5) Preoperative sore throat
6) Poor dentition with high risk of damage,loose teeth, edentulous patient
7)Pregnancy
 
 
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 the ease of intubation which include: 1.Time for achieving effective airway (seconds),
2.Ease of insertion of device: Score 1/ 2/ 3/ 4 / 5
3.Manipulation for achieving effective airway – yes/no
4.No of attempts - 1/2/3/ failure. 
To compare the ease of intubation which include: 1.Time for achieving effective airway (seconds),
2.Ease of insertion of device: Score 1/ 2/ 3/ 4 / 5
3.Manipulation for achieving effective airway – yes/no
4.No of attempts - 1/2/3/ failure. 
 
Secondary Outcome  
Outcome  TimePoints 
1) Cormack lehane grade 2) Maximum drop in saturation 3) Mucosal or dental trauma 4) Rescue intubation used or not
 
At the time of intubation, during the surgery, and post operative period
 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   25/11/2017 
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)  Open to Recruitment 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The importance and prevalence of supraglottic airway devices (SGDs) in airway management has increased considerably in recent years. The second generation supraglottic airway devices such as Laryngeal mask airway Proseal,  i-gel and Laryngeal mask airway Supreme have overcome the limitations of cLMA . They come with an inbuilt gastric drainage tube to empty stomach contents and are designed to provide better airway protection and higher oropharyngeal seal pressures as compared to first generation devices. These devices are a reasonable alternative choice to endotracheal intubation when performing anesthesia for procedures accompanied by high peak airway pressure, such as laparoscopic surgery. There is paucity of comparative studies between Ambu AuraGain and i- gel in literature. Therefore, in this study we will evaluate and compare clinical efficacy of Ambu AuraGain with i-gel as a ventilatory device in patients undergoing laparoscopic cholecystectomy under general anaesthesia with controlled ventilation. This study will be conducted in 80 adult patients of 18 to 60 years of age, of either gender, American society of Anaesthesiologists (ASA) physical status I and II, weighing 30 to 70 kg, undergoing elective laparoscopic cholecystectomy surgery under general anaesthesia with controlled ventilation in supine position.

Patients with anticipated difficult airway, cervical spine pathology, operation time greater than 4 hours, high risk of aspiration, preoperative sore throat, poor dentition with high risk of damage and pregnancy will be excluded. Block randomization in series of blocks of ten will be done to allocate patients to two groups of 40 each based on sealed envelope method.  After standard anesthesia technique the two devices will be inserted by standard technique an anesthesiologist who has experience of more than 30 successful insertion with both the devices. Airway manipulations such as jaw thrust or lateral rotation of device while inserting the device, head and neck flexion or extension, chin lift and change in the depth of device needed for achieving effective airway will be noted. Achieving both an effective airway and a successful insertion of gastric tube will be considered as a successful insertion of the device. The following parameters will be recorded oropharyngeal leak pressure after insertion of device , number of attempts, time for achieving effective airway, number of patients requiring manipulation, ease of insertion of device, ease of gastric catheter insertion, anatomical alignment of device, leak percent (percentage loss of set inspiratory volume) and adverse events if any. A p value of <0.05 will be considered statistically significant.The data will be entered in MS EXCEL spreadsheet and analysis will be done using latest version of Statistical Package for Social Sciences (SPSS) .

 

 

 

 

 

 

 


 
Close