| CTRI Number |
CTRI/2022/09/046032 [Registered on: 29/09/2022] Trial Registered Prospectively |
| Last Modified On: |
28/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of preoperative lignocaine lozenges with lignocaine nebulization for postoperative sore throat in adult patients undergoing general anaesthesia using laryngeal mask airway |
|
Scientific Title of Study
|
Comparison of preoperative lignocaine lozenges versus lignocaine nebulization for postoperative sore throat in adult patients undergoing general anaesthesia using laryngeal mask airway |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Farha Khan |
| Designation |
Post Graduate Resident |
| Affiliation |
ABVIMS AND DR RML HOSPITAL |
| Address |
Room No 301 Department of Anaesthesia PGI Building ABVIMS and DR.RMLH
ABVIMS and DR.RMLH, Baba Kharak Singh Road, New Delhi
ABVIMS AND DR RML HOSPITAL
BABA KHARAK SINGH ROAD
NEAR GURUDWARA BANGLA SAHIB ROAD
NEW DELHI 110001
Central
DELHI
110060
India |
| Phone |
7044723701 |
| Fax |
|
| Email |
khan.farha96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MOHANDEEP KAUR |
| Designation |
Professor and Head Of Department |
| Affiliation |
ABVIMS AND DR RML HOSPITAL |
| Address |
Room No. 301 Department of Anaesthesia 3rd Floor PGI Building ABVIMS Dr RMLH Baba kharak singh road New Delhi
Room No 301 Department of Anaesthesia 3rd Floor PGI Building ABVIMS DR RML HOSPITAL
Baba Kharak Singh Road
Near Gurdwara Bangla Sahib Road
New Delhi 110001
New Delhi
DELHI
110001
India |
| Phone |
9868952253 |
| Fax |
|
| Email |
mdkaur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Farha Khan |
| Designation |
Post Graduate Resident |
| Affiliation |
ABVIMS AND DR RML HOSPITAL |
| Address |
Room No 301 Department of Anaesthesia 3rd Floor PGI Building ABVIMS and DR.RMLH
ABVIMS and DR.RMLH Baba Kharak Singh Road New Delhi-110001
ABVIMS AND DR RML HOSPITAL
Baba Kharak Singh Road
Near Gurudwara Bangla Sahib Road
NEW DELHI 110001
Central
DELHI
110001
India |
| Phone |
7044723701 |
| Fax |
|
| Email |
khan.farha96@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS And DR RML Hospital |
|
|
Primary Sponsor
|
| Name |
Abvims And DR RML Hospital |
| Address |
Abvims And DR RML Hospital
Baba Kharak Singh Road
Near Gurudwara Bangla Sahib Road
NEW DELHI 110001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Farha Khan |
ABVIMS AND DR RML HOSPITAL |
ABVIMS AND DR RML HOSPITAL
BABA KHARAK SINGH ROAD
NEAR GURUDWARA BANGLA SAHIB ROAD
NEW DELHI 110001
Central
DELHI |
7044723701
khan.farha96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, ABVIMS, DR. RML HOSPITAL, NEW DELHI |
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 |
Lignocaine lozenges will be given to patient before putting laryngeal mask airway in patients undergoing general anaesthesia for surgery |
| Intervention |
Lignocaine nebulization |
Lignocaine nebulization will be given before putting laryngeal mask airway in patients undergoing general anaesthesia for surgery |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA PHYSICAL STATUS 1,2,3 POSTED FOR ELECTIVE SURGERY UNDER GENERAL ANAESTHESIA USING LARYNGEAL MASK AIRWAY |
|
| ExclusionCriteria |
| Details |
1. PATIENT REFUSAL
2. BMI>35
3. NECK CIRCUMFERENCE>40CM
4. PATIENTS REQUIRING REINTUBATION OR TRACHEOSTOMY
5. HISTORY OF ACTIVE UPPER RESPIRATORY TRACT INFECTION
6. MALLAMPATTI GRADE 3 AND ABOVE
7. HISTORY OF ALLERGY TO LIGNOCAINE
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Scoring Of Sore Throat Cough And Hoarseness As Per Harding
And Mcvey tool |
At extubation 5mins after extubation 10 mins after extubation 20 mins after extubation 30 mins after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number Of Attempts Of Lma Insertion
2.Cuff Pressure
3.Duration of Surgery |
Post Surgery |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
03/10/2022 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After proper selection of patients using the inclusion and exclusion criteria 53 patients will be taken in each group and will be given either lignocaine lozenges or lignocaine nebulization before undergoing general anaesthesia using laryngeal mask airway. Postoperative Sore Throat, cough and hoarseness will be compared in both groups |