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CTRI Number  CTRI/2023/06/054125 [Registered on: 19/06/2023] Trial Registered Prospectively
Last Modified On: 15/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between the effect of injecting 2% lignocaine inside the trachea or intravenous in reducing blood pressure and heart rate during visualisation of larynx and insertion of endotracheal tube inside the trachea  
Scientific Title of Study   Comparison between transtracheal and intravenous 2% lignocaine in attenuating hemodynamic stress response following direct laryngoscopy and endotracheal intubation 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Monotosh Pramanik 
Designation  Assistant Professor 
Affiliation  Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital  
Address  Department of Anesthesia Critical Care and Pain, 4th floor Operating theatre complex, Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Sundar Bagiya, BHU Campus

Varanasi
UTTAR PRADESH
221005
India 
Phone  8413044039  
Fax    
Email  mpramanikforyou@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Monotosh Pramanik  
Designation  Assistant Professor 
Affiliation  Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital  
Address  Department of Anesthesia Critical Care and Pain, 4th floor operating theatre complex, Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Sundar Bagiya, BHU Campus

Varanasi
UTTAR PRADESH
221005
India 
Phone  8413044039  
Fax    
Email  mpramanikforyou@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Monotosh Pramanik  
Designation  Assistant Professor 
Affiliation  Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital  
Address  Department of Anesthesia Critical Care and Pain, 4th floor operating theatre complex, Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Sundar Bagiya, BHU Campus

Varanasi
UTTAR PRADESH
221005
India 
Phone  8413044039  
Fax    
Email  mpramanikforyou@gmail.com  
 
Source of Monetary or Material Support  
Mahamana Pandit Madan Mohan Malviya Cancer Center and Homi Bhabha Cancer Hospital, Sunder Bagiya, BHU campus, Varanasi, Uttar Pradesh 221005 
 
Primary Sponsor  
Name  Dr Monotosh Pramanik 
Address  Department of Anaesthesia Critical Care and Pain 4th Floor Operating Theatre Complex Mahamana Pandit Madan Mohan Malviya Cancer Center and Homi Bhabha Cancer Hospital Sundar Bagiya BHU Campus Varanasi 221005 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  Not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
MONOTOSH PRAMANIK  Mahamana Pandit Madan Mohan Malviya Cancer Centre  Department of Anaesthesia Critical Care and Pain 4th Floor Operating Theatre Complex
Varanasi
UTTAR PRADESH 
8413044039

mpramanikforyou@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee MPMMCC and HBCH Varanasi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intravenous injection of 2% preservative-free lignocaine 1.5 mg/kg  After induction of general anesthesia patients will receive preservative-free inj. lignocaine 2% (Loxicard® 2%, Neon Laboratories Ltd, India) 1.5 mg/kg intravenously. After three minutes trachea will be intubated orally with appropriate-sized endotracheal tube using a Macintosh laryngoscope in a single attempt. Patients will be mechanically ventilated via mask and closed circuit system 
Intervention  Transtracheal injection of 2% preservative-free lignocaine 1.5 mg/kg  After induction of general anesthesia patients will receive preservative-free inj. lignocaine 2% (Loxicard® 2%, Neon Laboratories Ltd, India) 1.5 mg/kg through transtracheal access. As the patients will be mechanically ventilated via mask and closed circuit system in the head extended position, identification of cricothyroid membrane will be done by palpating thyroid cartilage and following it caudally until the membrane is detected in the space between the thyroid and cricoid cartilages. A 5 ml syringe will be loaded with the required drug and a 22 G needle will be attached to it. In the midline, the cricothyroid membrane will be pierced perpendicularly and aspiration of air will confirm its placement inside the trachea. The drug will be then instilled inside the trachea. After 3 minutes trachea will be intubated orally with appropriate-sized endotracheal using a Macintosh laryngoscope in a single attempt. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a)American Society of Anesthesiologists (ASA) I-II patients
b)Aged between 18–60 years of both sexes
c)Elective surgical cases under general anesthesia who will require direct laryngoscopy and endotracheal intubation
d)Mallampati score I & II
e)Single-attempt oral intubation
 
 
ExclusionCriteria 
Details  a)Patient refusal and patients who are unable to give valid consent
b)Pregnant patients
c)Known hypersensitivity to lignocaine
d)Anticipated difficult airway
e)Video laryngoscope-assisted intubation
f) Patients with restricted neck mobility
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare heart rate & blood pressure following direct laryngoscopy & endotracheal intubation in patients receiving 2 percent lignocaine, 1.5 mg/kg via transtracheal & intravenous route respectively.  At induction of general anaesthesia, Heart rate and blood pressure will be noted just prior to intubation, immediately after intubation & then at 1, 3, & 5 minutes post intubation.  
 
Secondary Outcome  
Outcome  TimePoints 
To note the incidence of postoperative sore throat in both groups.   In the recovery room at arrival & after 24 hrs 
 
Target Sample Size   Total Sample Size="138"
Sample Size from India="138" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="138" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   30/06/2023 
Date of Study Completion (India) 20/04/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Patients undergoing general anesthesia are required to be intubated for the purpose of maintaining a patent airway and mechanical ventilation. Direct laryngoscopy and endotracheal intubation are associated with increased sympathetic and adrenomedullary catecholamine activity resulting in a surge in heart rate and blood pressure. In the vulnerable group of patients, this sudden rise though for a brief period may cause adverse events like arrhythmias, myocardial infarction, cardiac failure, intracerebral hemorrhage, and raised intracranial pressure.
Over the years various methods have been in use to attenuate hemodynamic stress response during laryngoscopy and intubation. Lignocaine is one such agent which has been proven to be effective in the attenuation of a hemodynamic surge in response to laryngoscopy and endotracheal intubation. It has been used as an oral topical viscous solution, aerosolized/nebulized solution, laryngotracheal spray, and intravenous (IV) injection and found to be effective in previous studies.
During awake fiberoptic intubation, transtracheal application of lignocaine is routinely practiced to facilitate intubation. This topical application anesthetizes the infraglottic larynx and upper trachea and facilitates the prevention of hemodynamic surge during awake intubation. Though common during awake fiberoptic intubation, their use in post-induction endotracheal intubation has not been documented.
Disadvantages with oral topical viscous solution are additional preoperative preparation time, decreased effectiveness when oral secretions are present, and patient acceptance of oral anesthesia. Aerosolization with lignocaine is not routinely practiced as it often causes patient discomfort due to nebulization itself and the feeling of throat heaviness happens as anesthesia develops. It also requires extra preparation time. During laryngotracheal spray, after induction of general anesthesia, under direct vision with a standard Macintosh laryngoscope lignocaine is sprayed 2 minutes prior to intubation to allow its adequate effect to come. It requires lighter airway manipulation for this purpose prior to the actual intubation.
In our institute intravenous 2% lignocaine, 1.5mg/kg 3 minutes prior to endotracheal intubation is often administered to attenuate the hemodynamic response of laryngoscopy and intubation. The attenuating effect of intravenous lignocaine has been attributed to the arteriolar vasodilatation [10], blunting of the autonomic response, cough suppression, and increased depth of general anesthesia. In this study, we will administer transtracheal 2% lignocaine, 1.5 mg/kg following induction of general anesthesia and 3 minutes prior to endotracheal intubation. Transtracheal lignocaine causes reversible blockade of nerve fiber impulse propagation hence anesthetizes infraglottic laryngeal and upper tracheal mucosa.
As it will be performed following induction of general anesthesia it will cause no patient discomfort. It will not require any preoperative preparation and it will not involve any airway manipulation. Potential complications of transtracheal injection include subcutaneous and intratracheal bleeding, infection, subcutaneous emphysema, pneumomediastinum, pneumothorax, vocal cord trauma, and esophageal perforation. But these complications are rare, which was illustrated by a review of 17,500 cases of translaryngeal puncture that documented an incidence of complications of less than 0.01%. In our study, we hypothesize that post-induction transtracheal 2% lignocaine, 1.5 mg/kg will produce a similar effect as intravenous 2% lignocaine, 1.5 mg/kg and can be used as an alternative to attenuate the hemodynamic stress response of laryngoscopy and endotracheal intubation.

 
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