| CTRI Number |
CTRI/2024/09/073288 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of safety of two oral airway devices (I-gel and Blockbuster LMA) during complete Anesthesia in patients posted for gall bladder removal by durbeen |
|
Scientific Title of Study
|
Comparison of efficacy and safety of I gel and Blockbuster Laryngeal Mask
Airway for their insertion characteristics and oropharyngeal leak pressure in
patients undergoing laparoscopic cholecystectomy under general anaesthesia A randomised single blinded clinical study |
| 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 Surendra Kumar Sethi |
| Designation |
Professor |
| Affiliation |
R.N.T. Medical College, Udaipur |
| Address |
Dept of Anaesthesiology, RNT Medical College, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9587150598 |
| Fax |
|
| Email |
drsurendrasethi80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surendra Kumar Sethi |
| Designation |
Professor |
| Affiliation |
R.N.T. Medical College, Udaipur |
| Address |
Dept of Anaesthesiology, RNT Medical College, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9587150598 |
| Fax |
|
| Email |
drsurendrasethi80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mridula Sharma |
| Designation |
Junior Resident |
| Affiliation |
R.N.T. Medical College, Udaipur |
| Address |
Dept of Anaesthesiology, RNT Medical College, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9535060091 |
| Fax |
|
| Email |
mrisha110@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesiology, RNT Medical College, Udaipur,Rajasthan-313001 |
|
|
Primary Sponsor
|
| Name |
Dept of Anaesthesiology,RNT Medical College |
| Address |
RNT Medical College, Udaipur, Rajasthan-313001 |
| 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 Mridula Sharma |
MB Hospital and Rabindranath Tagore (RNT) Medical College |
Main Surgical Operation Theatre, 2nd floor, MB Hospital and RNT Medical College, Udaipur
Udaipur
RAJASTHAN |
9535060091
mrisha110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE RNT MEDICAL COLLEGE AND CONTROLLER AND ATTACHED HOSPITALS UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (3) ICD-10 Condition: K804||Calculus of bile duct with cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Blockbuster LMA |
Efficacy and safety of Blockbuster LMA for insertion characteristics and oropharyngeal leak pressure in patients undergoing laparoscopic cholecystectomy under general anaesthesia.( upto 90-120 minutes) |
| Intervention |
Comparison of I-gel and Blockbuster LMA |
Safety and efficacy of I-gel and Blockbuster LMA in laparoscopic cholecystectomy (upto 90-120 minutes) |
| Comparator Agent |
I-gel |
Efficacy and safety of I-gel for insertion characteristics and oropharyngeal leak pressure in patients undergoing laparoscopic cholecystectomy under general anaesthesia.( upto 90-120 minutes) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA-PS 1 or 2
Duration of surgery less than 90 minutes. |
|
| ExclusionCriteria |
| Details |
1. Patient Refusal
2. Patients with ASA PS 3 and above.
3. Silicone allergy
4. Patients who have received oxygen support or mechanical ventilation in the
past one month
5. Patients with risk factors for difficult airway
6. Any known pulmonary disease or cardiovascular
disease.
7. Risk of aspiration
8. Pregnant females
9. Patients with BMI more than 25 kg per metre square. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal Leak pressure |
Immediately after securing the airway (5min after Procedure) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ease of insertion,time of insertion, number of attempts at insertion, hemodynamic changes, complications if any, number of attempts at nasogastric tube insertion |
After successful insertion of the airway uptil 90 min |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
15/09/2024 |
| 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 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
|
My clinical study titled-Comparison of efficacy and safety of I-gel and Blockbuster Laryngeal Mask Airway for their insertion characteristics and oropharyngeal leak pressure in patients undergoing laparoscopic cholecystectomy under general anaesthesia: A randomised single-blinded clinical study. Our primary objective will be comparison of oropharyngeal leak pressure and secondary objective will be comparison of Ease of insertion, Time of insertion, Number of attempts at insertion, Haemodynamic changes, Complications, if any and Number of attempts at nasogastric tube insertion.Kindly consider it for CTRI registration. |