| CTRI Number |
CTRI/2024/09/074162 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to determine whether dexamethasone and 2 percent lignocaine can be used as an alternative to air for endotracheal tube cuff inflation so that post operative sore throat, cough, and other morbidities be reduced. |
|
Scientific Title of Study
|
A study to compare the effects on laryngotracheal morbidity of air, 2 percent alkalinized lignocaine and dexamethasone used for endotracheal tube cuff inflation, a 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 |
Subhrajyoti Das |
| Designation |
post graduate trainee, department of anesthesiology |
| Affiliation |
Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anesthesiology,
Sskm hospital,
AJC Bose Road,
Bhowanipore,
Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
09476361914 |
| Fax |
|
| Email |
subhronbmc2015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Baisakhi Laha |
| Designation |
Associate Professor, Department of anesthesiology |
| Affiliation |
Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anesthesiology,
Sskm hospital,
AJC Bose road,
Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
09830148042 |
| Fax |
|
| Email |
blowfans@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Subhrajyoti Das |
| Designation |
post graduate trainee, department of anesthesiology |
| Affiliation |
Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anesthesiology,
Sskm hospital,
AJC Bose Road,
Bhowanipore,
Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
09476361914 |
| Fax |
|
| Email |
subhronbmc2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Post Graduate Medical Education and Research, Government of West Bengal,
AJC Bose road,
Bhowanipore,
Kolkata
PIN: 700020
Country: INDIA |
|
|
Primary Sponsor
|
| Name |
Institute of Postgraduate Medical Educationand Research |
| Address |
AJC Bose Road,
Bhowanipore,
Kolkata,
PIN: 700020,
Country: INDIA |
| 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 Subhrajyoti Das |
Institute of Post Graduate Medical Education and Research |
Main OT complex, Trauma Care Centre, Urology OT,
Department of anesthesiology,
Institute of Post Graduate Medical Education and Research and SSKM Hospital,
AJC Bose Road,
Bhowanipore,
Kolkata
PIN: 700020
Country: INDIA
Kolkata
WEST BENGAL |
09476361914
subhronbmc2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
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 |
2% Alkalinized lignocaine,
|
2% lignocaine + sodium bicarbonate 7.5% (9ml + 1ml), this will be made into a stock solution of 10 ml. Around 4-6 ml will be used for inflating the endotracheal tube cuff after intubation until the air leak heard over trachea is lost.The cuff will remain inflated with this solution for the entire duration of surgery till extubation. Time period varies from 2 to 4 hours. |
| Comparator Agent |
air |
Air will be injected into the endotracheal tube cuff after intubation. This will serve as control. The cuff will remain inflated for the entire duration of surgery till extubation. Time period can vary from 2 to 4 hours. |
| Intervention |
Dexamethasone |
Dexamethasone 0.1 ml/kg in normal saline, for preparing a stock solution of 10 ml. Around 4-6 ml of this will be injected into the endotracheal tube cuff after until the air leak heard over trachea is lost.The cuff will remain inflated with this solution for the entire duration of surgery till extubation. Time period varies from 2 to 4 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
age 18 to 60 years, ASA 1 and 2 undergoing elective surgery under general anaesthesia, patient given written informed consent. |
|
| ExclusionCriteria |
| Details |
Duration of surgery 2 to 4 hrs, difficult airway requiring more than 2 trials of intubation, history of sore throat, allergies, bronchial asthma, chronic obstructive pulmonary disease, upper respiratory tract infections. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| sore throat incidence/severity |
1 hr,12 hr,24 hr post extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| hoarseness of voice |
1 hr,12 hr,24 hr post extubation |
| PONV |
1 hr,12 hr,24 hr post extubation |
| cough |
1 hr,12 hr,24 hr post extubation |
| dysphagia |
1 hr,12 hr,24 hr post extubation |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
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 3 |
|
Date of First Enrollment (India)
|
02/10/2024 |
| 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="0"
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
|
Endotracheal
intubation often causes several postoperative laryngotracheal morbidities like
sore throat, cough, dysphagia, hoarseness of voice. Different medications and
techniques have been adopted to relieve these complications. Injecting
alkalinized lignocaine into endotracheal tube cuff has already shown promising
results in various studies. Injection Ketamine used intracuff also gave comparable
results, but studies on intracuff dexamethasone are very few. Dexamethasone is a potent corticosteroid with analgesic,
anti-inflammatory, and antiemetic properties. Preoperative IV dexamethasone has
been reported to reduce the incidence of postoperative pain and swelling
following oral surgeries. Even when used intracuff, dexamethasone yielded
favorable results in the few studies that we have come across. Therefore, we
wish study the effects of injection Dexamethasone against 2% alkalinized
Lignocaine when used as an intracuff reservoir in relieving laryngotracheal morbidities.
|