| CTRI Number |
CTRI/2021/09/036284 [Registered on: 07/09/2021] Trial Registered Prospectively |
| Last Modified On: |
04/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of laryngeal airway devices in laproscopic gynecological procedures. |
|
Scientific Title of Study
|
Comparison of supraglottic airway devices: I-Gel versus Proseal laryngeal mask airway in elective laproscopic gynecological procedures. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSreeraghu G M |
| Designation |
Professor |
| Affiliation |
Kempegowda institute of medical sciences |
| Address |
kempegowda institute of medical sciences,department of anesthesiology, bangalore , karnataka
kempegowda institute of medical sciences,department of anesthesiology, bangalore , karnataka
Bangalore
KARNATAKA
560004
India |
| Phone |
8310285860 |
| Fax |
|
| Email |
aimsraghu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSreeraghu G M |
| Designation |
Professor |
| Affiliation |
Kempegowda institute of medical sciences |
| Address |
kempegowda institute of medical sciences,department of anesthesiology, bangalore , karnataka
kempegowda institute of medical sciences,department of anesthesiology, bangalore , karnataka
Bangalore
KARNATAKA
560004
India |
| Phone |
8310285860 |
| Fax |
|
| Email |
aimsraghu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrBHAVANA |
| Designation |
Postgraduate |
| Affiliation |
Kempegowda institute of medical sciences |
| Address |
kempegowda institute of medical sciences,department of anesthesiology, bangalore , karnataka
kempegowda institute of medical sciences,department of anesthesiology, bangalore , karnataka
Bangalore
KARNATAKA
560004
India |
| Phone |
9535755274 |
| Fax |
|
| Email |
madhurulesu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.BHAVANA (self), kims bangalore,department of anaesthesia , PG quarters room 308. |
|
|
Primary Sponsor
|
| Name |
DrBhavana |
| Address |
308,PG resident quarters, KIMS, Bangalore, Department of anaesthesia |
| 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 |
| DrBhavana |
Kempegowda Institute of medical science |
Department of anaesthesia, Ablock, 4th floor, Kempegowda institute of medical sciences,bangalore
Bangalore
KARNATAKA |
9535755274
madhurulesu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N832||Other and unspecified ovarian cysts, (2) ICD-10 Condition: N888||Other specified noninflammatory disorders of cervix uteri, (3) ICD-10 Condition: N938||Other specified abnormal uterine and vaginal bleeding, (4) ICD-10 Condition: N979||Female infertility, unspecified, (5) ICD-10 Condition: N958||Other specified menopausal and perimenopausal disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
I gel laryngeal mask airway |
patients posted for elective laproscopic gynecological procedures after induction and deepening the plane of anaesthesia airway is secured with i gel LMA and connected to anaesthesia machine and maintained on anesthesia , Ease of device insertion, Number of insertion attempts and Airway leak pressure is compared between the two LMA . |
| Comparator Agent |
nil |
nil |
| Intervention |
proseal laryngeal mask airway |
patients posted for elective laproscopic gynecological procedures after induction and deepening the plane of anaesthesia airway is secured with proseal LMA and connected to anaesthesia machine and maintained on anesthesia , Ease of device insertion, Number of insertion attempts and Airway leak pressure is compared between the two LMA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA 1 AND 2
patients with mallampati 1 and 2 |
|
| ExclusionCriteria |
| Details |
patients with anticipated difficult airway
h/o increased risk of regurgitation of gastric contents like full stomach , pregnancy, trauma , oesophageal motility disorders, intestinal obstruction. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ease of device insertion , number of insertion attempts and airway leak pressure between the LMAs are compared |
intraoperative monitoring from the beginning of surgery i.e LMA insertion to end of surgeryi.e reversal and removal of LMA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/09/2021 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
the study assess the ease of securing airway and airway leak pressures between the two LMA i.e I-Gel and Proseal . |