| CTRI Number |
CTRI/2024/07/070575 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study Comparing the vital fluctuations and ease of insertion of two types of Laryngeal Mask Airway |
|
Scientific Title of Study
|
A Comparative Study between ambu laryngeal mask airway And Baska Laryngeal Mask Airway in patients undergoing minor surgery under General Anaesthesia - A Prospective Randomized control Trial |
| 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 Suja R |
| Designation |
Post Graduate student |
| Affiliation |
Shri Sathya Sai Medical College And Research Institute |
| Address |
Department of Anesthesiology,Shri Sathya Sai Medical College and Research Institute
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9585210777 |
| Fax |
|
| Email |
sujaravi2703@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anusha Balasubramanian |
| Designation |
Associate Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anesthesiology,Shri Sathya Sai Medical College and Research Institute
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9003738506 |
| Fax |
|
| Email |
anusha14scorpio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suja R |
| Designation |
Post Graduate student |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anesthesiology,Shri Sathya Sai Medical College and Research Institute
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9585210777 |
| Fax |
|
| Email |
sujaravi2703@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai Medical College And Research Institute,Ammapettai,Kancheepuram,Tamilnadu 603108 |
|
|
Primary Sponsor
|
| Name |
Dr Suja R |
| Address |
Shri Sathya Sai Medical College And Research Institute,Ammapettai,Kancheepuram,Tamilnadu 603108 |
| 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 |
| Dr Suja R |
Shri Sathya Sai Medical College and Research Institute |
Department of Anaesthesia,2nd floor,OT complex,
Shri Sathya Sai Medical College and Research ,Ammapettai .603108
Kancheepuram
TAMIL NADU |
9585210777
sujaravi2703@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
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: K358||Other and unspecified acute appendicitis, (3) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ambu LMA |
Group 2 includes the Ambu LMA insertion in General Anaesthesia patient undergoing surgery in which we see ease and number of attempt of insertion, Blood Pressure,Heart rate, Saturation |
| Intervention |
BASKA LMA |
Group 1 includes the BASKA LMA insertion in General Anaesthesia patient undergoing surgery in which we see ease and number of attempt of insertion, Blood Pressure,Heart rate, Saturation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and ASA 2 patients undergoing minor surgery
|
|
| ExclusionCriteria |
| Details |
1.Surgery extending more than 45 minutes.
2.BMI ˃ 30kg/m2
3.Emergency procedures
4.Pregnancy
5.History of COPD, bronchial asthma. •History of gastro esophageal reflux disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the hemodynamic changes such as 1. Heart rate 2. systolic BP 3. diastolic BP
4.Mean arterial pressure between the two groups. |
At 0,1,3,5,10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
compare the 1.ease of insertion 2.time taken and
3. the number of attempts for insertion between the two groups. |
Number of attempts at 0,1 minute |
|
|
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)
|
23/07/2024 |
| 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="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
|
Pre anesthetic checkup will be done and those patients who fit into the inclusion criteria will be taken up for the study. Study will be started after ethical committee and institutional committee approval . • NPO of 6 hours for solid foods and 4 hours for liquids will be ensured in all the patients. They would be pre medicated with Tab. Alprazolam 0.5 mg the night before surgery followed by Inj. Pantoprazole 40 mg IV on the morning of surgery. IV access with 18G venflon secured in all patients. Monitors- Pulse oximeter, NIBP, ECG. ETCO2, Baseline values will be noted. • Group 1 includes the BASKA LMA insertion • Group 2 includes the AMBU LMA insertion • Patients will be monitored for the following • Blood pressure and heart rate will be monitored noninvasively. • Ease of intubation, number of attempts needed for placement of airway, time taken for insertion, Airway leak pressure is determined by closing the expiratory valve of the circle system at a fixed gas flow and recording the oropharyngeal leak pressure by detection of an audible noise using a stethoscope placed just lateral to the thyroid cartilage. • Intra and postoperative complications if any will be noted |