Oood

1. Principal investigator
DR. TUSHAR K MANKAR
GUIDE:
DR .M . SRINIVAS REDDY
PROFFESSOR
EFFECT OF INTRATRACHEAL AND INTRAVENOUS LIGNOCAINE ON
AIRWAY AND HEMODYNAMIC RESPONSE DURING EMERGENCE
AND EXTUBATION FOLLOWING GENERAL ANAESTHESIA : A
RANDOMIZED DOUBLE BLINDED COMPARATIVE STUDY

2. Tracheal extubation is the removal of endotracheal tube (ETT) from patient’s airway and is a
stressful situation, associated with 3 times more complication rates than intubation .
Complications of extubation include tube entrapment, hemodynamic changes such as
tachycardia, hypertension, increased intraocular and intracranial pressure, coughing,
breathholding, tracheal or laryngeal trauma, laryngeal spasm, and pulmonary aspiration [1,2,3].
Coughing and hemodynamic responses cause sympathoadrenergic responses due to
catecholamine release .
Lignocaine is a local anesthetic, causes blockade of the sodium channel , and suppresses cough
reflex to extubation by its effect on synaptic transmission and hemodynamic response by its
central stimulant effect, peripheral vasodilatory effect, and direct myocardial depressant effect [
4,5,6].

3. Lignocaine is administered intravenously , through laryngotracheal route or in the ETT cuff to blunt reflexes
during emergence from general anesthesia (GA) [7,8 ,9].
Emergence is defined as time period between the complete discontinuation of the maintenance anesthetic to 5
min post-extubation . The serum concentration of lignocaine required to suppress the cough reflex has been
recorded as >3 mcg/ml, while cough suppression has been achieved at recorded levels <1.63 mcg/ml when the
lignocaine is topically applied [10].
Lignocaine is a potent anti-inflammatory and antihyperalgesic agent [ 11,12, 13]. Even though cough reflex is
protective against aspiration, it can lead to hemodynamic fluctuations in post-operative period. George et al. [11]
found that the local mucosal anesthetizing effect of lignocaine is short lived and do not last for 20–30 min for
both intratracheal (IT) and intravenous (IV) lignocaine, thereby preventing aspiration risk.
Local anesthesia toxicity is a grave complication and requires high levels of alertness and anticipation [14, 15].
The main manifestations of its toxic accident are neurologic signs, with convulsions and no, or slight, cardiac
effects on the intact heart [18]. Cardiovascular effects come later, and they include myocardial depression,
prolonged conduction interval, bradycardia, hypotension, and heart failure [16, 17]. Administration of IV
lignocaine will rise plasma concentration rapidly as compared to IT lignocaine which contributes to such cardiac
complications.
Only a limited number of previous published studies compared the use of IT and IV lignocaine to reduce GA-
related complications during emergence and extubation . However, the results of these trials were conflicting.
Present study will be undertaken to compare efficacy of lignocaine administered through endotracheal tube to
lignocaine administered through intravenously

4. LIGNOCAINE
Lignocaine is a local anaesthetic with an amide linkage between the lipophilic benezene ring
and hydrophilic tertiary amine.
Lidocaine alters depolarization in neurons by blocking the fast voltage gated sodium channels
in the cell membrane. With sufficient blockade, the membrane of the presynaptic neuron will
not depolarize and so fails to transmit an action potential, leading to its anesthetic effects.
It gets metabolized by microsomal enzymes in the liver. The elimination half life of lidocaine
is approximately 1.5–2 hours in most patients. This may be prolonged in patients with hepatic
impairment and in congestive heart failure .
Lignocaine has long been used to modulate the unwanted airway and circulatory reflexes
seen in response to emergence and extubation. The administration of lignocaine has been
through several routes such as intravenous (IV) injection, endotracheal cuff, or intratracheal
instillation.

5. INTRAVENOUS LIGNOCAINE
I.V lignocaine effectively suppresses cough, I.V lignocaine (1.5 mg/kg) was used in several studies for
attenuation of stress response and produced significant decrease in cough responses.
INTRATRACHEAL LIGNOCAINE
Intratracheal lignocaine by instillation through endotracheal tube before extubation could significantly
reduce the incidence of coughing during extubation in patients undergoing surgery under general
anaesthesia . Local anaesthetics are rapidly absorbed into circulation following topical administration to
mucous membrane. Peak anaesthetic effect following topical application of lignocaine occur in 2 – 5 min and
anaesthesia last for 30-45 min.

6. Review of literature
1 .Divyagladston et al (2021) conductedintratracheallignocaine beforeextubation significantly
attenuatesthe post extubation coughreflex thanintravenouslignocaine (1)
2.Tabasum Shabnum et al (2017)conducted bothintratrachealandintravenous lignocaine effectivein
attenuating hemodynamicresponse before extubation (5)
3.George SEetal(2013) conducted study on comparison of effect oflignocaineinstilledthrough the
endotracheal tube and intravenouslignocaine on extubation responsein patients undergoing
craniotomywith skullpins(15)
Arun V Bidwaiet.al.(1979)conducted the study that intravenous administration of lignocaine depresses
cough reflexes during endotracheal extubation and to compare hemodynamic response to endotracheal
extubation (27)

7. AIM
The aim is to compare the effect of intravenous and intratracheal lignocaine on attenuation of airway
reflex to endotracheal extubation
OBJECTIVE
PRIMARY OBJECTIVE
To compare the effect of intratracheal lignocaine and intravenous lignocaine on airway reflexes using
smoothness of extubation
SECONDARY OBJECTIVE
1.To compare intratracheal and intravenous lignocaine on hemodynamic response (heart rate , systolic
blood pressure , diastolic blood pressure , mean arterial pressure) to extubation
2.To compare any side effects like bradycardia , and if any allergic reaction

8. MATERIAL AND METHODS
STUDY POPULATION
The study will be conducted upon in patients of MallaReddy Narayana MultispecialityHospital ,teritiary
care hospital , attached to MallaReddy Medical College For Women posted for surgical procedure
under general anaesthesia.
Inclusion Criteria
1. Patients undergoing surgical procedure under general anaesthesia.
2. Age 18 -65 years inclusive
3. ASA (American Society of Anaesthesiologist) class 1 & 2

9. Exclusion criteria :
Patients with
1. Sore throat or active URI
2.History of laryngeal or tracheal pathology/surgery.
3.History of asthma or COPD
4.Difficult intubation , obese patients
5.Patients with cardiovascular disease and respiratory disease and patients allergic to lignocaine

10. Study Design:Prospective Randomized Double Blinded Comparative
study.
Sample size : Study of 80 American society of anaesthesiology (ASA)
grade I and II patients

11. χ² tests - Goodness-of-fit tests: Contingency tables
Analysis: A priori: Compute required sample size
Input: Effect size w = 0.6155556
α err prob = 0.05
Power (1-β err prob) = 0.8
Df = 5
Output: Noncentrality parameter λ = 12.8828957
Critical χ² = 11.0704977
Total sample size = 34
Actual power = 0.8019718
By computing proportion of cough reflex of different grade
between group1 and group 2 effect size calculated was 0.610
with α err probability = 0.05 and power of the study 80%
sample size per group was 34

12. Randomization Procedure
The patients will be assigned to one of the following two groups using simple randomization ,
according to the computer generated table of random numbers
GROUP 1 – 2 % lignocaine 3 mg/kg intratracheal lignocaine and intravenous saline
GROUP II – 2% lignocaine 1.5 mg/kg intravenous lignocaine and intratracheal saline
Informed consent
After the approval of the study by the hospital ethics committee , the written informed consent will
be obtained from the patient and attenders explaining the procedure and risk factors involved in a
language understood by the patient . A copy of informed consent will be given to the patient and
attenders.

13. Ethics committee clearence :
The ethics committee approval will be sought
Information Collection
Patient demographic characteristics , including age , height , weight , BMI , ASA score and surgery duration will
be recorded . patient’s Heart rate , systolic blood pressure , diastolic blood pressure , mean arterial pressure
will be recorded and cough reflexes and smoothness of extubation will be recorded 1min , 2 min , 3min , 5min
, 10 min before and post extubation.
Observation will be made for any side effects such as sedation , bradycardia will be noted
Data collection procedure :
Institutional scientific committee and ethical committee approval will be obtained . Data will be collected by
taking the history, clinical examination ,and checking the investigation of patients , measurement will be made
during the study procedure and entered in data sheet and stored in excel sheet

14. Study Period : 12 Months ( May 2023 – April 2024)
Patient allocation :
The patients were randomly allocated into one of the 2 groups by randomization using computer
assignment. The study drug was allocated to patients by the another anaesthesiologist who is not involved in
study , data collection . participants were unaware of the group to which they were allocated .
Patients in group 1 received intratracheal lignocaine 3mg/kg and intravenous saline.
Patients in group 2 received intravenous lignocaine 1.5mg/kg and intratracheal saline.

15. Methodology
The patients will be visited on the evening before the surgery, the study will be explained
and written informed consent will be obtained. Patients were premedicated with diazepam
0.15 mg/kg per oral. On the day of surgery iv line , were started in the operating room and
monitoring established with ECG, NIBP , pulse oximetry, temperature monitor.
The patients will be induced using glycopyrolate 0.004 mg/kg ,Propofol 2mg/kg, Fentanyl 2
microgram/kg, along with oxygen/air/isoflurane, vecuronium 0.10mg/kg was administered to
facilitate intubation , maintained with air , oxygen , and isoflurane , allocated drugs were
given to patients in both groups 5 min before extubation . patients were reversed with
neostigmine 0.05 mg/kg and glycopyrrolate 0.001 mg/kg . After gentle aspiration of
oropharyngeal secretions ,extubation was performed when train of four count was more than
0.9. oxygen was supplemented through facemask and the airway response were noted in
terms of cough reflex to assess the smoothness of extubation and hemodynamic effect noted
in terms of heart rate , systolic blood pressure , diastolic blood pressure at extubation, 1 min ,
3 min , 5 min before and after extubation in group A and group B.
The tolerance to endotracheal tube at this time was noted and smoothness of
extubation graded as follows.
Grade 1: No cough or mild cough only during removal of endotracheal tube .
Grade 2: Coughing while breathing regularly.
Grade3: Bouts of coughing before regular breathing is established
The number of coughs were also noted

17. IMPLICATION
To study the effect of intatracheal and intravenous lignocaine on airway and hemodynamic respone during
emergence and extubation following general anaesthesia

18. PATIENT PROFORMA
Random Number :
Name: Date of admission:
Age: Sex: Patient I.P. No:
weight: Date of surgery:
height:
Clinical examination –
Pulse: B.P.:
CVS: RS: CNS:
Airway assessment-
Oral cavity:
Tooth:
Mallampati grade:
ASA grade 1 / grade 2 –

19. Investigations –
Hb%: RBS: Serum Creatinine:
Virology: Blood group INR:
CUE:
H/O of medical illness:
H/O of surgical illness:
H/O allergy:
Provisional diagnosis:
Plan of surgery:
Name of the drug:
Volume of drug:
Time of injection of drug:

20. PARAMETER BEFORE EXTUBATION 1min 3 min 5 min 10 min
HR
SBP
DBP
MAP
SMOOTHNESS OF EXTUBATION : 1/2/3
Grade 1: no cough or coughing only during removal of endotracheal tube.
Grade 2: coughing while breathing regularly.
Grade3: coughing while not breathing regularly

21. REFERENCES
GLADSTON DV , Padmam S , Amma Rao , Koshy RC . A randomized controlled trial to study the effect of intratracheal
and intravenous lignocaine on airway and hemodynamic response during emergence and extubation following
general anaesthesia . North Clin Istanb 2022 ;9(4):323-330
Shabnum T, Ali Z, Naqash IA, Mir AH, Azhar K, Zahoor SA, et al. Effects of lignocaine administered intravenously or
intratracheally on airway and hemodynamic responses during emergence and extubation in patients undergoing
elective craniotomies in supine position. Anesth Essays Res 2017;11:216–22.
George SE, Singh G, Mathew BS, Fleming D, Korula G. Comparison of the effect of lignocaine instilled through the
endotracheal tube and intravenous lignocaine on the extubation response in patients undergoing craniotomy with
skull pins: A randomized double blind clinical trial. J Anaesthesiol Clin Pharmacol2013;29:168–72.
Bidwai AV, Stanley TH, Bidwai VA. Blood pressure and pulse rate responses to extubation with and without prior
topical tracheal anaesthesia. Can Anaesth Soc J 1978;25:416–8.