| CTRI Number |
CTRI/2024/08/072485 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The use of 2% Lignocaine solution for inflating Endotracheal tube cuff, can lower the incidence of post operative sore throat , in patients undergoing general anaesthesia. |
|
Scientific Title of Study
|
The efficacy of intracuff instillation of 2% Lignocaine solution versus Air in Endotracheal Tube , in prevention of post operative sore throat, after surgery under General Anaesthesia - A Comparative Randomised Control Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PURBANIL BARUAH |
| Designation |
Post Graduate Student |
| Affiliation |
Tezpur Medical College |
| Address |
Department of Anaesthesiology and Critical Care
Tezpur Medical College
Bihaguri
District Sonitpur
Assam
India
Pin 784010
Sonitpur
ASSAM
784010
India |
| Phone |
6000404332 |
| Fax |
|
| Email |
Puravbaruah@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
DR ALTAFUDDIN AHMED |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Tezpur Medical College |
| Address |
Department of Anaesthesiology and Critical Care
Tezpur Medical College
Bihaguri
District Sonitpur
Assam
India
Pin 784010
Sonitpur
ASSAM
784010
India |
| Phone |
9435032380 |
| Fax |
|
| Email |
draltafahmeddbr@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
PURBANIL BARUAH |
| Designation |
Post Graduate Student |
| Affiliation |
Tezpur Medical College |
| Address |
Department of Anaesthesiology and Critical Care
Tezpur Medical College
Bihaguri
District Sonitpur
Assam
India
Pin 784010
Sonitpur
ASSAM
784010
India |
| Phone |
6000404332 |
| Fax |
|
| Email |
Puravbaruah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government supply of Tezpur Medical College
Department of Anaaesthesiology
Tezpur Medical College and Hospital
Bihaguri. Tezpur.
District - Sonitpur
Assam
India
Pin - 784010
|
| Self
Department of Anaesthesiology
Tezpur Medical College and Hospital
Bihaguri. Tezpur.
District - Sonitpur
Assam
India
Pin - 784010 |
|
|
Primary Sponsor
|
| Name |
Purbanil Baruah |
| Address |
Department of Anaesthesiology and Critical Care
Tezpur Medical College and Hospital
Bihaguri. Tezpur
District - Sonitpur
Assam
India
Pin - 784010 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 |
| Purbanil Baruah |
Tezpur Medical College and Hospital |
Department of Anaaesthesiology
Academic section
Sonitpur
ASSAM |
6000404332
Puravbaruah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Instillation of 2% Lignocaine solution in the Endotracheal tube cuff |
The selected patients will be intubated with the Endotracheal tube and the cuff of the tube will be inflated by using 2% Lignocaine solution instead of using air.The cuff pressure will be fixed at 20cm H2O . The selected cases will have the Endotracheal tube for a time duration not exceeding 2 hours. The patients will be evaluated post operatively for the presence of post operative sore throat. |
| Comparator Agent |
Instillation of air in the endotracheal tube cuff. |
The selected patients will be intubated with the Endotracheal tube and the cuff of the tube will be inflated using air. Room air will be used with a syringe to inflate the Endotracheal tube cuff. The cuff pressure will be fixed at 20cm H2O. The patients will be evaluated post operatively for the presence of post operative sore throat. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The following patients will be taken for the study-
Patients with ASA Grade 1 and 2.
Patients whose intra operative time is less than 2 hours .
Patients with Mallampati Grade 1 and 2.
Patients undergoing elective surgery under general anaesthesia .
|
|
| ExclusionCriteria |
| Details |
The following patients will be excluded from the study -
Patients who refuse to give consent to participate in the study.
Patients with difficult intubation ( Mallampati Grade 3 and 4).
Patients where intubation was done in 2nd attempt.
Patients having laryngeal disease or where surgery is being done on the head , neck or face.
Patients having known allergy to local anaesthetics agents.
Patients already having hsitory of sore throat , bronchial asthma, URTI, COPD or any other disease of the airway.
Patients who are uncoperative.
Patients who vomited in the last 24 hours before surgery.
Patients with ASA Grade 3 and 4.
Patients who are pregnant.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in the incidence of post operative sore throat |
Post operative sore throat measured at 30 minutes , 2 hours and 24 hour after extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in the incidence of post operative hoarseness of voice. |
Post operative hoarseness measured at 30 minutes and 12 hours after extubation. |
| Decrease in the incidence of post operative cough |
Post operative cough will be assesed at 0 minutes , 5 minutes and 30 minutes post extubation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
21/08/2024 |
| 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 Yet Recruiting |
| 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 is the gold standard for securing the airway in General Anaesthesia. Endotracjheal tube (ETT) can be inserted either through the nose or through the mouth. The distal end of the ETT lies in the mid trachea above the carina and it secures the airway and allows for the exchange of gases during ventillation. This also allows for the delivery of inhaled anaesthetic agents for the maintenance of anaesthesia in the patient during the course of the surgery. The cuffed ETT is routinely used in most surgeries. The cuff is inflated to provide a seal in the trachea. This prevents aspiration to the lungs and also ensures the Tidal volume given to the lungs doesnot escape to the upper airway.
Sore throat is a common side effect of general anaesthesia. It is found in approximately 30 to 70 percent cases of tracheal intubation. The post operative sore throat is caused due to the mucosal irritation of the ETT against the tracheal wall.
The ET tube cuff can act as a reservoir for the local anaesthetic agent . The local anaesthetic agent thus given diffuses slowly and causes subsequent anaesthesia of the undeerlying mucosa. Therefore the topical anaesthetic agent thus applied can act as a novel technique to reduce adverse emergence phenomenon including post operative sore throat , coughing etc.
This study compares the effect of intra cuff instillation of lignocaine versus air in endotracheal tube in prevention of post operative sore throat in surgeries done under general anaesthesia.
|