| CTRI Number |
CTRI/2021/08/035945 [Registered on: 26/08/2021] Trial Registered Prospectively |
| Last Modified On: |
25/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison between SLIPA and I-gel |
|
Scientific Title of Study
|
comparative study between streamlined liner of pharynx airway and I-gel in patients undergoing surgery under general anaesthesia in a tertiary care hospital in chengalpattu district - a randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DHINESH KUMAR C |
| Designation |
post graduate student |
| Affiliation |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE,THIRUPORRU GUDUVANCHERRY MAIN ROAD, CHENGALPET TALUK, AMMAPETTAI, KANCHEEPURAM DISTRICT
DEPARTMENT OF ANAESTHESIOLOGY
2ND FLOOR OT COMPLEX,
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE
CHENNAI
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9790744463 |
| Fax |
|
| Email |
dhinudon31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRVIJAY NARAYANANS |
| Designation |
PROFESSOR |
| Affiliation |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE,THIRUPORRU GUDUVANCHERRY MAIN ROAD, CHENGALPET TALUK, AMMAPETTAI, KANCHEEPURAM DISTRICT
DEPARTMENT OF ANAESTHESIOLOGY
2ND FLOOR OT COMPLEX,
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE
CHENNAI
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9444877188 |
| Fax |
|
| Email |
dr.vijay@live.in |
|
Details of Contact Person
Public Query
|
| Name |
DHINESH KUMAR C |
| Designation |
post graduate student |
| Affiliation |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE,THIRUPORRU GUDUVANCHERRY MAIN ROAD, CHENGALPET TALUK, AMMAPETTAI, KANCHEEPURAM DISTRICT
DEPARTMENT OF ANAESTHESIOLOGY
2ND FLOOR OT COMPLEX,
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE
CHENNAI
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9790744463 |
| Fax |
|
| Email |
dhinudon31@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri sathya sai medical college hospital and research institute |
|
|
Primary Sponsor
|
| Name |
DHINESH KUMAR C |
| Address |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE
THIRUPORUR GUDUVANCHERRY MAIN ROAD,CHENGALPET TALUK,AMMAPETTAI,KANCHEEPURAM DISTRICT |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DHINESH KUMAR C |
OPERATION THEATRE -1, 2ND FLOOR OT COMPLEX, SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE,THIRUPORUR GUDUVANCHERRY MAIN ROAD, CHENGALPET TALUK, AMMAPETTAI, KANCHEEPURAM DISTRICT
Kancheepuram
TAMIL NADU |
9790744463
dhinudon31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
I-GEL |
GROUP-1 will include SLIPA INSERTION further intraoperatively,patients will be monitered forhemodynamic factors like blood pressure and heartrate.both groups will be compared for easw of insertion,number of attempts,airway leak pressure difference and time taken for insertion,also postoperatively any complications will be noted |
| Comparator Agent |
SLIPA |
GROUP-2 will include I-GEL insertion.further intraoperatively,patients will be monitered forhemodynamic factors like blood pressure and heartrate.both groups will be compared for easw of insertion,number of attempts,airway leak pressure difference and time taken for insertion,also postoperatively any complications will be noted |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged from 18 – 60 years
ASA grade I and II undergoing minor surgical procedures.
Â
|
|
| ExclusionCriteria |
| Details |
Surgery extending more than 45 minutes.
BMI ˃ 30kg/m2
Emergency procedures
Pregnancy
History of COPD, bronchial asthma.
History of gastro esophageal reflux disease
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|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the heamodynamic changes such as Heart rate, systolic BP, diastolic BP, Mean arterial pressure between the two groups.
|
5 min, 10min, 15min, 30 min. 45 min
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the ease of insertion, number of attempts and time taken |
intraoperatively for 5 min , 10 min, 15min 30 MIN 45 MIN |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
01/09/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pre anesthetic checkup will be done and those
patients who fit into the inclusion criteria will be taken up for the study.
NPO of 6 hours for solid foods and 4 hours for
liquids (prior to the procedure) will be ensured in all the patients. They
would be pre medicated with Tab. Alprazolam 0.5 mg the night before surgery
followed by Inj. Pantoprazole 40 mg IV on the morning of surgery. IV
access with 18G venflon secured in all patients. Monitors- Pulse
oximeter, NIBP, ECG. ETCO2, Baseline values will be noted.
Group 1 includes the SLIPA insertion
Group 2 includes the I GEL insertion
Patients will be monitored for the following
Blood pressure and heart rate will be monitored
noninvasively.
Ease of intubation, number of attempts needed for
placement of airway, time taken for insertion, Airway leak pressure is
determined by closing the expiratory valve of the circle system at a fixed gas
flow and recording the oropharyngeal leak pressure by detection of an audible
noise using a stethoscope placed just lateral to the thyroid cartilage.
Intra and postoperative complications if any will
be noted.
|