| CTRI Number |
CTRI/2024/11/076331 [Registered on: 06/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
For securing airway Blockbuster laryngeal mask airway and Endotracheal tube is used-which is better |
|
Scientific Title of Study
|
Comparison of efficacy of Blockbuster laryngeal mask airway and Endotracheal tube in securing airway in women undergoing elective gynaecological laparoscopic surgeries- A randomized comparative 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 |
Ananta Lagwal |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. S.N. Medical College Jodhpur |
| Address |
Department of Anaesthesiology and critical care, Dr S.N Medical College MDM Hospital Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
8628809447 |
| Fax |
|
| Email |
anulagwal1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Rajpurohit |
| Designation |
Professor |
| Affiliation |
Dr. S.N. Medical College Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care Dr S.N Medical College Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9928060011 |
| Fax |
|
| Email |
drvikasrajpurohit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas Rajpurohit |
| Designation |
Professor |
| Affiliation |
Dr. S.N. Medical College Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care Dr S.N Medical College Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9928060011 |
| Fax |
|
| Email |
drvikasrajpurohit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr S.N Medical College,Department of anaesthesiology, Shastrinagar, Jodhpur Rajasthan-342003 |
|
|
Primary Sponsor
|
| Name |
Dr. S.N. Medical College Jodhpur |
| Address |
Dr. S.N. Medical College Shastrinagar Jodhpur Rajasthan-342003 |
| 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 Ananta Lagwal |
MDM Hospital |
Department of Anaesthesiology and critical care, Janana OT, Janana wing, Shastrinagar, Jodhpur Rajasthan-342003
Jodhpur
RAJASTHAN |
8628809447
anulagwal1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Dr S.N. Medical College Jodhpur |
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 |
Blockbuster LMA vs Endotracheal tube |
there are two groups, Group E is assigned with patients in whom endotracheal tube will be used for securing airway and group B is assigned with patients in whom blockbuster LMA will be used for securing airway and then both the groups will be compared for changes in hemodynamic parameters,adequacy of ventilation, number of attempts and duration of insertion of both devices and postoperative complications associated with use of both devices in women undergoing elective gynaecological laparoscopic surgeries of duration less than 1 hour |
| Comparator Agent |
Endotracheal tube vs Blockbuster LMA |
In this sttudy, i will compare the efficacy of blockbuster LMA and endotracheal tube in securing airway in terms of hemodynamic parameters, adequacy of ventilation, number of attempts taken and duration of insertion of these two devices and finding out the post operative complications associated with their use in women undergoing elective laparoscopic gynaecological surgeries of duration less than 1 hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
adult women whose age is more than 18 years with BMI less than 30kg/m2 of ASA class 1 and 2 and MPG grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
Severe cardiovascular disease (known case of Hypertension, CAD, MI, Angina, CVA), cervical spine disease, MPG grade 3 and 4, Mouth opening less than 3 finger width, loose teeth, oral pathology, risk of aspiration(known case of GERD, hiatus hernia) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing the variability in hemodynamic parameters(BP,HR,MAP) during blockbuster LMA insertion with endotracheal tube insertion |
From before induction of anaesthesia till 5 min after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparing the adequacy of ventilation (spo2, RR, ETCO2, Peak airway pressure, tidal volume), number of attempts & duration of insertion of two devices & finding out the post operative complications(cough,hoarseness of voice, sore throat) associated with use of blockbuster LMA & Endotracheal tube |
From 1 minute after intubation till 5 min after extubation |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/12/2024 |
| 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="0"
Months="6"
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
|
The aim of the study is to compare the efficacy of Blockbuster LMA with Endotracheal tube in securing airway in women undergoing elective gynaecological laparoscopic surgeries Primary objective- To compare the variability in hemodynamic parameters(BP.HR,MAP) with insertion of blockbuster LMA and endotracheal tube. secondary objectives - To compare the adequacy of ventilation(SPO2,ETCO2,RR,Peak airway pressure and tidal volume) , number of attempts and duration of insertion of blockbuster LMA with endotracheal tube and finding out incidence of post operative side effects(cough, hoarseness of voice, sore throat) asssociated while using blockbuster LMA and endotracheal tube. |