| CTRI Number |
CTRI/2024/01/061288 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
02/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A RANDOMIZED COMPARATIVE STUDY TO OBSERVE THE SAFETY AND EFFICACY OF BLOCKBUSTER LARYNGEAL MASK AIRWAY WITH FASTRACH LARYNGEAL MASK AIRWAY USED IN PATIENTS UNDERGOING ELECTIVE SURGICAL PROCEDURE UNDER GENERAL ANAESTHESIA |
|
Scientific Title of Study
|
A RANDOMIZED COMPARATIVE STUDY TO OBSERVE THE SAFETY AND EFFICACY OF BLOCKBUSTER LARYNGEAL MASK AIRWAY WITH FASTRACH LARYNGEAL MASK AIRWAY USED IN PATIENTS UNDERGOING ELECTIVE SURGICAL PROCEDURE UNDER GENERAL ANAESTHESIA |
| 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 Arvind khare |
| Designation |
Senior professor |
| Affiliation |
J.l.n medical college |
| Address |
Department of anesthesiology, new ot,1st floor JLN medical hospital Kala hag,Ajmer
Department of anesthesiology, new ot,1st floor JLN medical hospital Kala hag,Ajmer
Ajmer
RAJASTHAN
305004
India |
| Phone |
9414306114 |
| Fax |
|
| Email |
arvindkhare68@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind khare |
| Designation |
Senior professor |
| Affiliation |
J.l.n medical college |
| Address |
Department of anesthesiology, new ot,1st floor JLN medical hospital Kala hag Ajmer
Department of anesthesiology, new ot,1st floor JLN medical hospital Kala hag Ajmer
Ajmer
RAJASTHAN
305004
India |
| Phone |
9414306114 |
| Fax |
|
| Email |
arvindkhare68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reena Meena |
| Designation |
Junior Resident |
| Affiliation |
J.l.n medical college |
| Address |
Department of anesthesiology, new ot,1st floor JLN medical hospital Kala hag,Ajmer
Department of anesthesiology, new ot,1st floor JLN medical hospital Kala hag,Ajmer
Ajmer
RAJASTHAN
305004
India |
| Phone |
9079643846 |
| Fax |
|
| Email |
Reenam94m@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawahar Lal Nehru medical college |
|
|
Primary Sponsor
|
| Name |
Jawahar Lal Nehru medical college |
| Address |
Jawahar Lal Nehru medical college |
| 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 Arvind khare |
Jawahar Lal Nehru medical college |
Department of anesthesiology, new ot,1st floor JLN medical hospital Kala hag,Ajmer
Ajmer
RAJASTHAN |
9414306114
arvindkhare68@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee JLNMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Block buster LMA |
With due approval from institutional ethical committee,a prospective, hospital based, single has been planned on 80 adult patients of either sex. participants will be alloted into group BB inserted block buster LMA . Will be compared for esae of insertion. A written informed constant Will be taken from participants prior the procedure |
| Comparator Agent |
Fastrach LMA |
With due approval from institutional ethical committee,a prospective, hospital based, single has been planned on 80 adult patients of either sex. participants will be alloted into group FL inserted Fastrach LMA. Will be compared for esae of insertion. A written informed constant Will be taken from participants prior the procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
. Age 18years and above
. Patients belonging to American society of Anesthesiology Grade I and II
.Patients of either sex
.Mallampati score I and II
.Patients weighing between 40kg to 60kg
.Elective surgical procedure lasting for 90 min
|
|
| ExclusionCriteria |
| Details |
.American Society of A nesthesiology grade III, IV, V
.Mallampati score III and IV
.Patients weighing <40kg or >60kg
.Pregnant female
.Mouth opening <2 cm
.Obese with body mass index >30kg/m2
.Patients with loose dentures
.Cervical spine disease
.Upper respiratory tract infection
.Oral pathology
.Anticipated difficult tracheal intubation or facemask ventilation
.Risk of aspiration and history of regurgitation |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First attempt for successful endotracheal intubation in percentage |
asses using a subjective scale. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Ease of LMA insertion
2.Time taken for first successful endotracheal intubation
3. Second attempt for successful endotracheal intubation in percentage
4. Oropharyngeal seal pressure
5. Hemodynamic parameters(Heart rate ,SDP,DBP,MAP)
6.Any adverse effects - injury to lips, teeth, bloodstaining, laryngospasm and sore throat |
assess as grading point system. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/01/2024 |
| 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
|
With due approval from institutional ethical committee, a prospective, hospital based, single blind, randomized, comparative, study has been planned on 80 adult patients. The present study will be conducted on the patients undergoing elective surgical procedure under general anaesthesia in the Department of Anaesthesia at J.L.N Medical College and Associated group of Hospital, Ajmer. a written informed consent will be obtained from all the patients after complete explanation about the study protocol, anaesthtic technique, merits and demerits of the procedure and perioperative course of anaesthesia. |