Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy

Detailed Description
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Direct laryngoscopy and intubation are painful stimulus that activates sympathoadrenal discharge which results in intense cardiovascular reflex i.e. tachycardia and hypertension. In this study we will compare effects of intravenous dexmedetomidine, fentanyl and lidocaine for attenuation of these reflexes in patient undergoing laproscopic cholecystectomy. how these agents will effect hemodynamic response during pneumoperitoneum. Tertiary objective will be to observe sedation, perioperative complications and recovery in these patients.

Official Title
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Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy

Conditions
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Laparoscopic Cholecystectomy

Intervention / Treatment
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* Drug: dexmedetomidine
* Drug: fentanyl
* Drug: lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA-I and ll patients Male and female patient of age 20-70 years. Undergoing Elective surgery Intubation by skilled anesthetist of at least 2 years' experience Intubation not more than 45 seconds Exclusion Criteria: Patients with uncontrolled DM, HTN, IHD, endocrine or autonomic dysfunction Pregnant and lactating females Short thick neck with anticipated difficult intubation Any sort of obstructive restrictive or reactive airway disease Patient allergic to any of the study medications. Obese patients, Narcotic addicts

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Randomized control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>Group A patients receive intravenous dexmedetomidine 0.06mg/kg in 100ml normal saline 0.9% over 10minutes. | Drug: dexmedetomidine<br>* intravenous dexmedetomidine 0.06mg/kg in 100ml normal saline 0.9% over 10minutes.<br>|
| Experimental: Fentanyl<br>Group B receives intravenous fentanyl at 2mcg/kg in 100ml saline over 10 minutes in induction room. | Drug: fentanyl<br>* intravenous fentanyl at 2mcg/kg in 100ml saline over 10 minutes in induction room.<br>|
| Experimental: Lidocaine<br>Group C patients receives intravenous lidocaine 1.5mg/kg in 100ml saline over 10 minutes in induction room. | Drug: lidocaine<br>* intravenous lidocaine 1.5mg/kg in 100ml saline over 10 minutes in induction room.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic blood pressure | hermodynamic response (Top number will be assessed of blood pressure) | at induction | 
| Diastolic blood pressure | hermodynamic response (bottom number will be assessed of blood pressure) | at induction | 
| mean atrial pressure | Hemodynamic responses (average blood pressure in an individual during a single cardiac cycle) | at induction | 
| Heart rate | Hemodynamic responses (average heart rate beats a minute) | at induction | 
| Oxygen saturation (SpO2) | Hemodynamic responses) (arterial oxy-hemoglobin saturation is measured non-invasively by a finger pulse oximeter or handheld pulse oximeter, | at induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation assessment | Ramsey score use for sedation, it consist of 1-6 where 6 indicates worst(no response) and 6 indicates good response | at 10 minutes post operative | 
| Recovery assessment | Aldret score use for recovery assessment, it consist of 0-10 point where 0 indicates worst(no response) and 10 indicates good response | at 10 minutes post operatively | 
| Complications | Cough, Laryngospasm, Bradycardia, Regugitation, PONV, Hypertention, Hypotension | 1 week Post-operative(Operation -discharge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Fentanyl, Lignocaine, Laryngoscopy, Hemodynamic Response, Laparoscopic Cholecystectomy