| CTRI Number |
CTRI/2023/03/050187 [Registered on: 01/03/2023] Trial Registered Prospectively |
| Last Modified On: |
27/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Instilling lignocaine(a local anaesthetic) through the endotracheal tube for prevention of cough during removal of endotracheal tube(extubation) and comparing its effectiveness to instilling normal saline |
|
Scientific Title of Study
|
Comparison of the effectiveness of endotracheal instillation of lignocaine versus normal saline in prevention of cough during extubation after elective laparoscopic surgeries : A randomized control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep A Dongare |
| Designation |
Assistant professor |
| Affiliation |
ESIC MEDICAL COLLEGE AND PGIMSR,RAJAJI NAGAR |
| Address |
Department of Anaesthesiology, ESIC Medical college and PGIMSR, Rajajinagar, Bangalore
Bangalore
KARNATAKA
560010
India |
| Phone |
8310738801 |
| Fax |
|
| Email |
pradeep.dongare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep A Dongare |
| Designation |
Assistant professor |
| Affiliation |
ESIC MEDICAL COLLEGE AND PGIMSR,RAJAJI NAGAR |
| Address |
Department of Anaesthesiology, ESIC Medical college and PGIMSR, Rajajinagar, Bangalore
KARNATAKA
560010
India |
| Phone |
8310738801 |
| Fax |
|
| Email |
pradeep.dongare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep A Dongare |
| Designation |
Assistant professor |
| Affiliation |
ESIC MEDICAL COLLEGE AND PGIMSR,RAJAJI NAGAR |
| Address |
Department of Anaesthesiology, ESIC Medical college and PGIMSR, Rajajinagar, Bangalore
KARNATAKA
560010
India |
| Phone |
8310738801 |
| Fax |
|
| Email |
pradeep.dongare@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC MEDICAL COLLEGE AND PGIMSR, RAJAJINAGAR, BANGALORE |
|
|
Primary Sponsor
|
| Name |
ESIC MEDICAL COLLEGE AND PGIMSR |
| Address |
Rajajinagar, Bangalore |
| 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 |
| HARI PRABHAKAR K |
ESIC MEDICAL COLLEGE AND PGIMSR |
OT COMPLEX,DEPARTEMENT OF ANAESTHESIOLOGY,RAJAJINAGAR, BANGALORE
Bangalore
KARNATAKA |
88388632729
hariprabhakar.kumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, ESIC MEDICAL COLLEGE & PGIMSR, RAJAJI NAGAR, BANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LIGNOCAINE |
Dose - 1mg/kg diluted to 5ml
Frequency - once at the time of wound dressing
Route of administration - through the endotracheal tube
Duration - the drug is once administered and occurence of cough during extubation and heart rate and bp will ne monitored each minute for 10 mins after extubation |
| Comparator Agent |
NORMAL SALINE |
Dose - 5ml
Frequency - once at the time of wound dressing
Route of administration - through the endotracheal tube
Duration - the normal saline is once administered and occurence of cough during extubation and heart rate and bp will ne monitored each minute for 10 mins after extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing to give informed consent (Annexure-1)
2.American Society of Anesthesiologists (ASA) physical status I or II.
(Annexure 2)
3.Elective laparoscopic surgical procedures of a duration of 1-1.5hours under general anaesthesia with requirement for endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
1.Patient with risk factors for difficult airway (mouth opening of <2cm, Mallampatti class 4, limited neck extension, history of previous difficult intubation)
2.Patients with known pulmonary and cardiovascular diseases.
3.Patients having sore throat or active Upper Respiratory Infection (URI), history of laryngeal or tracheal pathology/surgery, history of asthma or Chronic Obstructive Pulmonary Disease(COPD).
4.Known allergy to local anaesthetic.
5.Patients on beta-blocker therapy.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NUMBER AND GRADE OF COUGH |
At base line (during extubation) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HEART RATE AND BLOOD PRESSURE |
EVERY MINUTE UPTO 10 MINS AFTER EXTUBATION |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
06/03/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A typical clinical issue, coughing upon coming out of general anaesthesia can cause potentially harmful patient movements, hypertension, tachycardia or other arrhythmias, myocardial ischaemia, surgical haemorrhage, bronchospasm, and a rise in intracranial and intraocular pressure. In individuals with coronary artery disease, cerebrovascular disease, or intracranial hypertension, coughing during extubation may have harmful implications. Lidocaine is a local anaesthetic which has long been used to obtund intubation response. According to studies, stimulation of the larynx, trachea, and carina all result in haemodynamic abnormalities that lidocaine prevents. The larynx is the one that causes the greatest reaction among them.Endotracheal instillation of Lidocaine in the cuff in order to inflate the cuff prevents coughing and thereby prevents an increase in blood pressure and heart rate throughout the surgery. But repeated instillation may be required as it may get absorbed through the cuff. Endotracheal instillation of Lidocaine has been shown to obtund intubation response. Similar instillation through the endotracheal tube to obtund the response to extubation is sparsely studied.
The aim of the study is to investigate whether endotracheal instillation of lignocaine attenuates cough and airway circulatory reflex during extubation after elective laparoscopic surgeries requiring general anaesthesia. |