| CTRI Number |
CTRI/2025/07/091484 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"A Study Comparing Gargled vs. Injected Lignocaine in Helping Patients Tolerate laryngeal mask airway Insertion During Anesthesia"
laryngeal mask airway |
|
Scientific Title of Study
|
A RANDOMISED PROSPECTIVE OBSERVATIONAL STUDY TO COMPARE THE EFFICACY OF 2 PERCENT LIGNOCAINE VISCOUS GARGLES AND 2 PERCENT INTRAVENOUS LIGNOCAINE IN FACILITATING LARYNGEAL MASK AIRWAY INSERTION |
| 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 Sachin Desai |
| Designation |
Junior Resident |
| Affiliation |
Sardar Patel Medical College, Bikaner |
| Address |
DEPARTMENT OF ANESTHESIA , A BLOCK , PBM HOSPITAL BIKANER
Bikaner
RAJASTHAN
334001
India |
| Phone |
7727997791 |
| Fax |
|
| Email |
Sachin.desai1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Aeron |
| Designation |
Associate Professor |
| Affiliation |
Sardar Patel Medical College, Bikaner |
| Address |
DEPARTMENT OF ANESTHESIA, A BLOCK, PBM HOSPITAL, BIKANER
Bikaner
RAJASTHAN
334001
India |
| Phone |
9416336907 |
| Fax |
|
| Email |
nga6016@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Aeron |
| Designation |
Associate Professor |
| Affiliation |
Sardar Patel Medical College, Bikaner |
| Address |
DEPARTMENT OF ANESTHESIA, A BLOCK, PBM HOPSITAL, BIKANER
Bikaner
RAJASTHAN
334001
India |
| Phone |
9416336907 |
| Fax |
|
| Email |
nga6016@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Patel medical college , bikaner (334001) rajasthan, india |
|
|
Primary Sponsor
|
| Name |
Sardar patel medical college, bikaner |
| Address |
SP Medical College Rd, PBM Hospital, Sardar Patel Colony, Bikaner, Rajasthan 334001 |
| 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 Sachin Desai |
Sardar Patel Medical College , Bikaner |
DEPARTMENT OF ANESTHESIA, OT A BLOCK, PBM HOSPITAL, BIKANER, RAJASTHAN 334001
Bikaner
RAJASTHAN |
07727997791
sachin.desai1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Reasearch Board ,SPMC Bikaner |
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 |
| Comparator Agent |
2 Percent Lignocaine Intravenous Injection |
Dose: 1mgPerKg (Maximum 100mg) Diluted Appropriately |
| Intervention |
2 Percent Lignocaine Viscous Solution |
Route: Topical
Dosage: 15ml of 2 Percent Viscous Solution
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient belonging to ASA grade 1 and 2 scheduled for elective surgeries of short duration feasible under LMA. |
|
| ExclusionCriteria |
| Details |
1.Patient who are not willing to participate in the study.
2.Allergy to any of the drugs used in the study.
3.Patients with an anticipated difficult airway.
4.Patients with any history of coronary artery disease, uncontrolled hypertension, endocrinal disease, respiratory disease and metabolic disorder.
5.Pregnant and lactating mothers.
6.Patient with mouth opening less than 2.5cm
7.Smokers |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ease of Laryngeal Mask Airway (LMA) insertion assessed by presence or absence of gagging, coughing, and laryngospasm.
Measured using a 4point grading scale (gagging Grade 0 to 3 coughing and laryngospasm as None, Mild, Moderate, Severe. |
At the time of LMA insertion and up to 2 minutes post insertion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic changes in systolic BP, diastolic BP, MAP. |
Baseline (before induction)
Immediately before LMA insertion
1, 2, 3, 4, 5 minutes post-insertion
Every 5 minutes till 30 minutes after insertion |
| Number of Attempts for insertion of LMA And time taken for insertion. |
At the Time of LMA Insertion |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2025 |
| 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)
|
Open to Recruitment |
| 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
|
this is a prospective, single blinded, randomized controlled trail conducted in a tertiary care hospital. the study aims to compare the efficacy of 2% lignocaine viscous gargles versus 2% intravenous lignocaine in faciliting the insertion of a LMA. The primary outcomes will be ease of LMA insertion and secondary will include hemodynamic stablity. |