Intravenous Lignocaine vs Placebo

Study Overview
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Brief Summary
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To assess the mean hemodynamic responses post-intubation in patients given intravenous lignocaine pre-intubation as compared to a placebo pre-intubation in patients undergoing laryngoscopy surgery

Detailed Description
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After identifying the candidate, details will be carefully discussed with the subject. The subject (or, when necessary, the parent or legal guardian if the subject is younger than 18 years of age or under guardianship) will be read the approved protocol consent form. Patients who have given informed consent to participate in the study will be randomized into one of the two study arms one day before the procedure. The study team present will open the sealed envelopes provided by the Indus Hospital Research Center's Clinical Research Unit (CRU) that provides the study arm allocation. The envelopes will follow the SNOSE protocol.

Official Title
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Effect of Intravenous Lignocaine vs Placebo on Hemodynamic Response During Intubation

Conditions
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Hemodynamic Stability Post Intubation in Laryngoscopy Surgery

Intervention / Treatment
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* Drug: iv Lignocaine vs placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I and II Age 20-60 years Mallampatti , II All surgeries are done under GA Both genders Those patients giving informed consent Exclusion Criteria: Difficult airway assessed during pre-op anaesthesia assessment Unanticipated difficult airway based on the previous history of difficult intubation BMI >30, Micrognathia and microglossia based on pre-op anaesthesia assessment, Diabetic patient with autonomic dysfunction liver disease, cardiovascular disease, pheochromocytoma, Cushing syndrome Patients who do not give informed consent

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Equal allocation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lignocaine group<br>This group will be given 1.5 mg/kg I/V lignocaine before intubation | Drug: iv Lignocaine vs placebo<br>* Lignocaine is available in an ampule of 10 ml containing 20 mg/ml of lignocaine or 2%, Lignocaine will be given in dose of 1.5 mg/kg I/V<br>|
| Placebo Comparator: Placebo<br>This group will be given 6 ml normal saline before intubation | Drug: iv Lignocaine vs placebo<br>* Lignocaine is available in an ampule of 10 ml containing 20 mg/ml of lignocaine or 2%, Lignocaine will be given in dose of 1.5 mg/kg I/V<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAP | mean arterial pressure | post-intubation 3 minutes to 10 minutes | 
| Pulse | Heart rate | post-intubation 3 minutes to 10 minutes |