| CTRI Number |
CTRI/2024/02/062179 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| 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
|
Comparision of Buska mask over I-Gel LMA in laproscopic gynaecological procedure |
|
Scientific Title of Study
|
A Randomised Clinical study To Compare BASKA MASK Vs I-GEL in Female Patients undergoing Diagnostic Laproscopic Gynaecological surgeries under General Anaesthesia |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Beena Thada |
| Designation |
Associate Proffesor |
| Affiliation |
JLN medical college ajmer |
| Address |
Department of anaesthesiology New OT 1st floor Jawahar Lal nehru Medical College and hospital Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9352260425 |
| Fax |
|
| Email |
drbeenaverma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Beena Thada |
| Designation |
Associate Proffesor |
| Affiliation |
JLN medical college ajmer |
| Address |
Department of Anaesthesiology Neo OT 1st floor Jawahar Lal Nehru Medical College and hospitals Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9352260425 |
| Fax |
|
| Email |
drbeenaverma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Beena Thada |
| Designation |
Associate Proffesor |
| Affiliation |
JLN medical college ajmer |
| Address |
Department of Anaesthesiology New OT 1st floor Jawahar Lal Nehru medical college and Hospital Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9352260425 |
| Fax |
|
| Email |
drbeenaverma@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of anaesthesiology JLN medical collge Ajmer |
|
|
Primary Sponsor
|
| Name |
Deparrment of anaesthesiology JLN medical college |
| Address |
New OT first floor JLN medical Hospital kala bagh ajmer rajasthan pin code 305001 |
| 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 |
| DrMahesh |
zanana hospital |
Zanana OT department of anaesthesiology 1st floor Zanana hospital lohagal, ajmer
Ajmer
RAJASTHAN |
8607159437
mudgalmahesh007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee Jawahar lal nehru medical college ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N838||Other noninflammatory disorders ofovary, fallopian tube and broad ligament, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BASKA LMA |
Upon arrival in operation theatre, the written informed consent, PAC, and nil per oral status will be confirmed. Study population (100) will be randomly divided into two groups by opaque sealed envelope technique.
The Baska Mask will be lubricated and introduced into the mouth toward the hard palate and advanced downward until resistance felt.As an one time procedure and kept throughout the procedure. patients will be monitored for mean airway leak pressure, ease of insertion, peak airway pressure throughout procedure till mask is removed and postoperative complication |
| Comparator Agent |
I-GEL LMA |
Upon arrival in operation theatre, the written informed consent, PAC, and nil per oral status will be confirmed. Study population (100) will be randomly divided into two groups by opaque sealed envelope technique.while inserting I-GEL the tip of the I-Gel will be introduced into the mouth of the patient against the hard palate, avoiding the tongue, and glided downward and backward until a definitive resistance will
be felt.As a one time insertion and kept in place throughout the procedure.patients will be monitored for mean airway leak pressure, ease of insertion, peak airway pressure throughout the procedure till it is removed and postoperative complication |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Adult female of 20-40yrs age group
2. Weight of 30-60kgs
3. ASA grade I and II
4. Undergoing Diagnostic laproscopic gynaecological surgeries under
general anaesthesia.
5. Surgeries lasting upto 60 minutes. |
|
| ExclusionCriteria |
| Details |
1.known airway difficulty
2.mouth opening less than 2.5 cm
3.obesity
4.negative patient consent
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the mean Oropharyngeal Leak Pressure(OLP) just after
successful insertion and 10 minutes after creating pneumoperitoneum. |
just after successful insertion of LMA, at 10 mnts after creating pneumoperitoneum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.to compare ease of insertion
2.to compare peak airway pressure
3.post operative complication |
1.at the time of insertion
2.before , during and just after creating pneumoperitoneum
3.immediate postoperative |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
06/02/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Upon arrival in operation theatre, the written informed consent, PAC, and nil
per oral status will be confirmed. Study population (100) will be randomly
divided into two groups by opaque sealed envelope technique. Group B (n=50)
will receive Baska Mask and Group I(n=50) will receive I-Gel. In case of securing the airway with supraglottic airway device while using
Baska Mask, the patient will be placed in sniffing position. The Baska Mask
will be lubricated and introduced into the mouth toward the hard palate and
advanced downward until resistance felt. while using I-GEL . The tip of the I-Gel
will be introduced into the mouth of the patient against the hard palate, avoiding
the tongue, and glided downward and backward until a definitive resistance will
be felt. patient will be monitored for mean oropharyngeal leak pressure as primary objective and ease of insertion, peak airway pressure and post operative complication as secondary objective. data will be collected and analysed using standard tests , p value of less than 0.05 will be considered significant |