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
|
|
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
|
|
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) .
|