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
|
|
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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