| CTRI Number |
CTRI/2022/04/041674 [Registered on: 06/04/2022] Trial Registered Prospectively |
| Last Modified On: |
05/04/2022 |
| 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 Comparative study between i-gel and Proseal LMA in adult patients undergoing elective laparoscopic cholecystectomy under general anaesthesia: A randomised controlled study.â€
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Scientific Title of Study
|
“A Comparative study between i-gel and Proseal LMA in adult patients undergoing elective laparoscopic cholecystectomy under general anaesthesia: A randomised controlled study.â€
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shrawan Parameshwar Bhagat |
| Designation |
Junior Resident |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anesthesiology, RIMS,Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
7368964895 |
| Fax |
|
| Email |
shrawanpb09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Kumar |
| Designation |
Associate Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anesthesiology, RIMS,Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
8709135297 |
| Fax |
|
| Email |
drkmukesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shrawan Parameshwar Bhagat |
| Designation |
Junior Resident |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anesthesiology, RIMS,Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
7368964895 |
| Fax |
|
| Email |
shrawanpb09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology RIMS Ranchi |
|
|
Primary Sponsor
|
| Name |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anesthesiology,RIMS, Ranchi |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shrawan Parameshwar Bhagat |
Rajendra Institute of Medical Sciences |
Department of Anesthesiology
Ranchi
JHARKHAND |
7368964895
shrawanpb09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajendra Institute of Medical Sciences |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
I-gel insertion |
60 min |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Proseal LMA insertion |
60 min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient’s consent
Weighing between 40-80 kg
ASA physical status I & II
Mallampatti class I & II
|
|
| ExclusionCriteria |
| Details |
Patient’s refusal
ASA grade III & IV
Age less than 18 years and more than 60 years.
Weight less than 50 kg or more than 80 kg.
Patient with upper respiratory tract infection.
Mallampatti class III & IV.
Patient with h/o hypertension, DM, coronary heart disease.
Patient with increased risk of aspiration (GE reflux, hiatus hernia, Pregnancy).
Injury, deformity or any pathology of the airway
|
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1.Knowing the oropharyngeal sealing pressure with Proseal LMA.
2.Knowing the oropharyngeal sealing pressure with i-gel.
|
0min,10min,30min
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Ease of insertion
Time taken to achieve airway control
Any side effects or complications as sore throat, needs of manipulation of supraglottic airway during surgery
|
at the end of surgery,60 min,90 min |
|
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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" |
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Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/04/2022 |
| 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="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Publications
- For how long will this data be available start date provided 29-03-2022 and end date provided 31-10-2022?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
Supraglottic airway devices are now used for airway control during spontaneous and controlled ventilation under general anaesthesia. The safety of these devices with gastric access has been accessed through some studies in laparoscopic cholecystectomy over last decade. Though studies have been done for LMA, few have been performed to evaluate i-gel for Laparoscopic Cholecystectomy This study will be done to compare i-gel and Proseal LMA for airway sealing pressure during volume control ventilation for their use in elective laparoscopic cholecystectomy
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