| CTRI Number |
CTRI/2023/01/048818 [Registered on: 09/01/2023] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing effect of two drugs given locally to a patient taken up for general anaesthesia when securing an airway device. |
|
Scientific Title of Study
|
Comparison of Lignocaine Nebulization versus Lignocaine Lozenges on
hemodynamics during BlockBusterTM Airway Insertion in patients scheduled for General
Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vivek Pandit |
| Designation |
Post Graduate - Junior Resident |
| Affiliation |
Government Medical College and Hospital, Chandiagarh |
| Address |
Department of Anaesthesia and Intensive Care, D Block, Level V,
Government Medical College and Hospital
Chandigarh
CHANDIGARH
160030
India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8198071757 |
| Fax |
|
| Email |
dr.pandit.vivek@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manpreet Singh |
| Designation |
Professor, Department of Anaesthesia and Intensive Care |
| Affiliation |
Government Medial College and Hospital, Chandiagarh |
| Address |
Department of Anaesthesia and Intensive Care, D Block, Level V, Government Medical College and Hospital
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121503 |
| Fax |
|
| Email |
manpreetdawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivek Pandit |
| Designation |
Post Graduate - Junior Resident |
| Affiliation |
Government Medical College and Hospital, Chandiagarh |
| Address |
Department of Anaesthesia and Intensive Care, D Block, Level V,
Government Medical College and Hospital
Chandigarh
CHANDIGARH
160030
India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8198071757 |
| Fax |
|
| Email |
dr.pandit.vivek@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive Care, D Block, Level V, Government Medical College and Hospital |
| 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 Vivek Pandit |
Government Medical College and Hospital |
Department of Anaesthesia and Intensive Care, D Block, Level V,
Government Medical College and Hospital
Chandigarh
PIN-160030
India
Chandigarh
CHANDIGARH |
8198071757
dr.pandit.vivek@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMCH Chandigarh |
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 |
Lignocaine Lozenges |
Troikaa Xynova 200 Lozenges containing 200mg of Lignocaine for oral use till fully dissolved 5 minutes before taking patient to Operation Room |
| Intervention |
Lignocaine Nebulization |
Patient to be nebulizeÄ with 10ml of 2% Lignocaine amounting to 200mg of Lignocaine till nebulization lasts 5 minutes before taking patient to Operative Room
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in age group of 18-60 years
2. American Society of Anaesthesiologists (ASA) Status I and II
3. Patients undergoing surgery requiring general anaesthesia with laryngeal mask airway
not requiring any other laryngeal or pharyngeal intervention. |
|
| ExclusionCriteria |
| Details |
1. Patients allergic to lignocaine hydrochloride
2. Patients with difficult airway with Airway difficulty score >8
3. Morbid obesity BMI > 35 kg/m2
4. Known airway pathology
5. Oropharyngeal surgeries
6. Surgery duration more than 3 hours
7. Patients at increased risk of aspiration like GERD, peptic ulcer, non fasting status
8. Previous upper gastrointestinal surgery
9. Known or anticipated difficult tracheal intubation or facemask ventilation
10. Coagulopathy or history of anticoagulant use
11. Cardiorespiratory or cerebrovascular disease
12. Cervical spine injury
13. Pregnant Patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the Heart Rate, Noninvasive Blood Pressure, ECG changes and Oxygen Saturation in
patients during BlockbusterTM LMA insertion |
All these parameters to be taken prior to intervention (baseline), immediately after intervention, at the time of airway insertion and 1 minute, 2 minutes, 3 minutes, 5 minutes and 10 minutes after airway insertion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ECG Changes |
ECG Changes- Before intervention, after intervention, at the time of securing airway, 1min, 2 min, 3 min, 5 min, 10 min after securing airway |
| Anaphylaxis, Systemic toxicity, circulatory disturbances, neurological impairments |
Before intervention, after intervention, at the time of securing airway, 1min, 2 min, 3 min, 5 min, 10 min after securing airway
Anaphylaxis - Immediately after intervention to note down any side effects related to the drug
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2023 |
| Date of Study Completion (India) |
27/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
27/03/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.pandit.vivek@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - None
|
|
Brief Summary
|
Securing airway is of utmost importance for an anaesthetist at the time of general anaesthesia. Laryngeal Masks Airways(LMAs) were introduced as an alternative to endotracheal tube to prevent trauma to the airway and decrease intubation response on hemodynamics of a patient during laryngoscopy. These hemodynamic responses can further be reduced by anaesthetising the airway. In this study, we use lignocaine to anaesthetise the airway by using 2 modes of drug delivery - nebulization and lozenges, and comparing which out of them is more efficient in blunting the hemodynamic response during LMA insertion ( We have used BlockBuster Airway for this study), by studying the Heart Rate, Blood Pressure and also the SpO2 of the patients.Other parameters like ECG changes, anaphylactic reactions, systemic toxicity, circulatory disturbances and any neurological deficits will also be studied during the trial.
Over the next 1.5 years, we aim to study the above in a group of 100 ASA - I and II patients and conclude as to which out of the 2 interventions will serve a better overall modality as a mode of anaesthetising the airway. |