| CTRI Number |
CTRI/2024/06/069626 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| 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
|
A clinical Comparative study between efficiency of LMA-Supreme and I-Gel in adult patients undergoing elective surgery |
|
Scientific Title of Study
|
A Comparative Study between efficiency of LMA-Supreme and I-Gel in adult patients undergoing elective surgery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Subhash Dahiya |
| Designation |
Professor |
| Affiliation |
LLRM Medical college |
| Address |
Department of Anaesthesia
LLRM medical college Meerut
Uttar Pradesh
250004
India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9837056949 |
| Fax |
|
| Email |
drsubhashllrm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhash Dahiya |
| Designation |
Professor |
| Affiliation |
LLRM Medical college |
| Address |
Department of Anaesthesia
LLRM medical college Meerut
Uttar Pradesh
250004
India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9837056949 |
| Fax |
|
| Email |
drsubhashllrm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balsingh kethavath |
| Designation |
Junior Resident |
| Affiliation |
LLRM Medical college |
| Address |
Ground floor Department of Anaesthesia
LLRM Medical college Meerut
Uttar Pradesh
Meerut
UTTAR PRADESH
250004
India |
| Phone |
7569873634 |
| Fax |
|
| Email |
balsingh8411@gmail.com |
|
|
Source of Monetary or Material Support
|
| LLRM Medical college
Department of Anaesthesia Meerut
Uttar Pradesh 250004 |
|
|
Primary Sponsor
|
| Name |
LLRM Medical college |
| Address |
LLRM Medical college
Department of Anaesthesia Meerut
Uttar Pradesh 250004 |
| 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 Subhash Dahiya |
LLRM Medical college |
Department of Anaesthesia
LLRM Medical college Meerut
Uttar Pradesh 250004
Meerut
UTTAR PRADESH |
9837056949
drsubhashllrm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA grade I and grade II undergoing elective surgery under general anaesthesia |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
I-Gel |
The I-Gel is the innovative second generation supraglottic airway device.Made from medical grade thermoplastic elastomer .I- Gel has been designed to create a non inflatable,anatomical seal of the pharyngeal ,laryngeal and peri pharyngeal structures while avoiding compression trauma.we compare various parameters every 5 min in first half an hour and every 30 min thereafter |
| Intervention |
Insertion of supraglottic airway devices |
Comparison of various parameters like heamodynamic changes,Oropharyngeal airway seal pressure and other complications after insertion of SGA devices.
We conducted this study over 2 years |
| Comparator Agent |
Supreme-LMA |
Supreme-LMA is a single use second generation with gastric access device which forms an effective first seal with the oropharynx (oropharyngeal seal) and an innovative second seal with upper oesophageal sphincter (oesophageal seal).we compare various parameters every 5 minutes till first half an hour and every 30 min thereafter. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grade I and grade II patients
2.age 18-60 years of either sex
3.patients undergoing elective surgeries in supine position
4.patients with informed consent
5.BMI 18-25
6.Haemodynamically stable patients |
|
| ExclusionCriteria |
| Details |
1.patient refusal
2.mallampatti grade III and IV
3.potentially full stomach patients
4.coagulation disorders
5.severe systemic disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal seal pressure |
After correct placement (around 10 min) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate,SBP,DBP,oxygen saturation,post-op complications like sore throat,hoarseness and any injury |
Base line,every 5 minutes of initial 15 minutes and then every 15 minutes till the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/07/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Comparative study between efficiency of Supreme-LMA and I-Gel in adult patients undergoing elective surgery .We conducted this study for 2 years.we compared changes in heamodynamic parameters,oropharyngeal airway seal pressure and other complications .conducted this study in healthy patients with minimum comorbidities. |