| CTRI Number |
CTRI/2022/09/045908 [Registered on: 27/09/2022] Trial Registered Prospectively |
| Last Modified On: |
14/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision between baska mask and I-gel insertion in minor surgeries under general anaesthesia |
|
Scientific Title of Study
|
Comparison between baska mask and I- gel Insertion in minor surgery under general anaesthesia in Patient age 18-50 years:-a randomized interventional study at SMS medical college, during 2021-2023 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunita Meena |
| Designation |
Associate Professor |
| Affiliation |
Sms medical collage and attached hospital |
| Address |
Department of anaesthesiology,SMS medical college and attached hospitals, Adarsh nagar Jaipur
pin 302004
Rajasthan
Department of anaesthesiology JLN Marg Adarsh Nagar Jaipur
pin 302004
RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
9461290011 |
| Fax |
302004 |
| Email |
sunitameena98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Meena |
| Designation |
Associate Professor |
| Affiliation |
Sms medical collage and attached hospital |
| Address |
Department of anaesthesiology,SMS medical college and attached hospitals, Adarsh nagar Jaipur
pin 302004
Rajasthan
Department of anaesthesiology JLN marg Adarsh Nagar Jaipur
pin 302004
RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
9461290011 |
| Fax |
302004 |
| Email |
sunitameena98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandani sharma |
| Designation |
Junior resident |
| Affiliation |
Sms medical collage and attached hospital |
| Address |
Department of anaesthesiology,SMS medical college and attached hospitals, Adarsh nagar Jaipur
pin 302004 Jaipur
RAJASTHAN
Department of anaesthesiology,Adarsh nagar Jaipur
pin 302004
RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
7568667393 |
| Fax |
302004 |
| Email |
Nandanisharma244@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, SMS Medical College and Attached Hospitals |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology SMS Medical College and hospitals |
| Address |
JLN Marg Adarsh Nagar Jaipur Pin 302004 |
| 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 sunita meena |
Sawai Man Singh Medical College and Attached Hospitals |
Department of anaesthesiology JLN Marg, Adarsh Nagar,Jaipur pin:-302004
Jaipur
RAJASTHAN |
9461290011
sunitameena98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sawai Man Singh Medical College ethics Committee |
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 |
baska mask |
after induction baska mask is inserted and oropharyngeal leak pressure is checked just after intubation and after 5 min |
| Comparator Agent |
I-Gel |
after induction I-Gel is inserted and oropharyngeal leak pressure is checked just after intubation and 5 min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patient of 18-50 years of age .
2.Weight of 30-60 kgs
3.ASA grade I and II
4.Undergoing minor surgical procedure under general anaesthesia.
5.Sex both male and female |
|
| ExclusionCriteria |
| Details |
1.Known/predicted difficult airway
2.mouth opening <2.5cm
3.with increase risk of aspiration of gastric content .
4.surgery time more than 1 hour.
5.obesity ( BMI>30kg/m2)
6.negative patient consent |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the difference in mean orophargeal leak pressure in both groups after insertion and 5 min later. |
just after insertion, after 5 min
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| attempts of insertion |
preoperatively and intraoperatively |
| haemodynamic HR,SBP,MAP,SPO2,ETCO2 |
baseline, before induction,just after induction, after 1 min, after 5 min,then every 5 min till 40 min, at 50 min ,at 60 min |
| grading of ease of insertion |
pre and intraoperatively |
| insertion time |
time between picking up airway device and 1st capnographic reading |
| manipulation frequency |
intraoperatively |
| postoperatively removal charactestics-blood staining on device,trauma to lip,tongue or teeth,sump clearance,gastric fluid in airway cavity |
postoperatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/10/2022 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We want to compare between baska mask and I-gel insertion in minor surgery under general Anesthesia in patient aged 18-50 years .to determine in mean orophargeal Leak pressure in both groups after insertion and 5 min later .to determine in insertion characteristic in both the groups.to determine the difference in removal characteristics and percentages of postop complications.
|