Dexmedetomidine or Lidocaine for Lessening the Hemodynamic Responses to Laryngoscopy and Intubation

Study Overview
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Brief Summary
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Laryngoscopy, tracheal intubation, surgical stimulation, and extubation unleash remarkable sympathetic activity and are associated with transient but significant hemodynamic changes. The need to blunt these noxious responses effectively has led to using several techniques and pharmacological agents, local anesthetics, beta-adrenergic-blockers, calcium channel antagonists, and opioids with varied success. This study aims to evaluate the effect of nebulized and intravenous either dexmedetomidine or lidocaine for attenuating the hemodynamic responses to laryngoscopy and intubation.

Detailed Description
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Hemodynamic responses to laryngoscopy and intubation are a significant concern for the anesthesiologist. Laryngoscopy, tracheal intubation, surgical stimulation, and extubation unleash remarkable sympathetic activity and are associated with transient but significant hemodynamic changes. These hemodynamic derangements can be lethal in patients with multiple comorbidities. The need to blunt these noxious responses effectively has led to using several techniques and pharmacological agents, local anesthetics, beta-adrenergic-blockers, calcium channel antagonists, and opioids with varied success. This study aims to evaluate the effect of nebulized and intravenous either dexmedetomidine or lidocaine for attenuating the hemodynamic responses to laryngoscopy and intubation.

Official Title
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Comparing Intravenous Versus Nebulized Either Lidocaine or Dexmedetomidine for Attenuation of the Hemodynamic Responses to Laryngoscopy and Intubation

Conditions
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Anesthesia Intubation Complication

Intervention / Treatment
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* Drug: Dexmedetomidine nebulization
* Drug: Lidocaine nebulization
* Drug: Dexmedetomidine IV
* Drug: Lidocaine IV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The American Society of Anesthesiologists (ASA) physical status I & II. BMI: ((≤ 35 kg/m2)). The patients are to be scheduled to undergo elective surgery under general anesthesia. Mallampati grade I, II Exclusion Criteria: Uncooperative patient. History of allergy to study drugs. Hemodynamically unstable patient. Renal or hepatic dysfunction or hypertensive patients.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine nebulization<br>The patient will receive nebulized dexmedetomidine via face mask nebulizer (1mcg/kg) 20 minutes before induction. | Drug: Dexmedetomidine nebulization<br>* The patient will receive nebulized dexmedetomidine via face mask nebulizer 10 minutes before induction of general anesthesia.<br>* Other names: Precedex (200 mcg/2ml);|
| Active Comparator: Lidocaine Nebulization<br>The patient will receive nebulized lidocaine 4% (3 mg /kg) added to 2 ml normal saline 0.9% 10 minutes before induction of general anesthesia. | Drug: Lidocaine nebulization<br>* The patient will receive nebulized lidocaine 4% (3 mg /kg) 10 minutes before induction of general anesthesia.<br>* Other names: Lidocaine 2% (20 mg/ml);|
| Active Comparator: Dexmedetomidine IV<br>The patient will receive an intravenous infusion of dexmedetomidine (1 ml= 4 mcg) via a syringe pump and will be started at a dose of 1 mcg/kg 20 minutes before induction of general anesthesia. | Drug: Dexmedetomidine IV<br>* The patient will receive intravenous infusion via a syringe pump of dexmedetomidine (1 ml= 4mcg) started at a dose of 1 mcg/kg 20 minutes before induction of general anesthesia.<br>* Other names: Precedex;|
| Active Comparator: Lidocaine IV<br>The patient will receive 1.5mg/kg intravenous lidocaine 2% completed to 10 ml with normal saline 0.9% intravenous 90 seconds before induction of general anesthesia. | Drug: Lidocaine IV<br>* The patient will receive 1.5 mg/kg lidocaine 2% (1 ml = 20mg) completed to 10 ml with normal saline 0.9% intravenous 90 seconds before induction of general anesthesia.<br>* Other names: Lidocaine 2% (20 mg/ml);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum cortisol levels. | Base line blood sample will be drawn 45 minutes preoperative and 10 minutes post intubation for cortisol level measurements. | Measurement will be done 45 minutes preoperative and 10 minutes after endotracheal intubation. | 
| Change in mean arterial blood pressure (MAP) in mmHg. | Mean arterial pressure (MAP) will be recorded 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation. | Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation. | 
| Change in heart rate (HR) per minute. | Heart rate (HR) will be recorded 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation. | Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation. | 
| Change in systolic blood pressure (SBP) in mmHg. | Systolic blood pressure (SBP)will be recorded 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation. | Measurement will be done 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation. | 
| Change in diastolic blood pressure (DBP) in mmHg. | Diastolic blood pressure (SBP)will be recorded 10 minutes before induction and at 1,3,5,7 and 10 minutes after endotracheal intubation. | Measurement will be done 10 minutes before induction and at 1,3,5,7 and10 minutes after endotracheal intubation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Lidocaine