Intratracheal Dexmedetomidine Versus Lidocaine in Eye Surgery

Study Overview
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Brief Summary
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Cough during emergence from general anesthesia is considered a critical event as it may lead to surgical bleeding laryngospasm hemodynamic instability and could be life-threatening in patients who are at risk of complications related to increases in intracranial or intraocular pressure. Lidocaine administration has been widely used for reducing cough during extubation due to its simplicity and lack of serious adverse effects; There are two major routes for lidocaine administration systemic intravenous injection and local direct application on the laryngeal inlets such as spraying lidocaine on the supraglottic and subglottic regions or applying lidocaine jelly or sprayed. Dexmedetomidine is a potent alpha 2 selective adrenoceptor agonist and the most characteristic features include sympatholytic sedation analgesia and lack of respiratory depression. The aim of this study is to compare the effect of intratracheal dexmedetomidine and lidocaine on cough reflex in cataract surgery.

Detailed Description
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The patients were randomly allocated into three groups each containing (40) patient. Group D received (0.5 μg/kg) of dexmedetomidine diluted and completed to 5 ml saline, Group L received (5ml) 2% of lidocaine and Group C received 5ml saline. The drugs were sprayed down the intratracheal tube of patients. The following variables: Hemodynamic parameters HR, MAP, and SaO2 values in different times, preoperative IOP, cough, steward recovery score (SRS), detection of awareness and extubation time, the incidence of complications due to increasing IOP and surgeon satisfaction

Official Title
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The Efficacy and Safety of Intratracheal Dexmedetomidine Versus Lidocaine for Smooth Tracheal Extubation in Patients Undergoing Eye-surgery.

Conditions
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Postoperative Complications

Intervention / Treatment
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* Drug: intratracheal saline
* Drug: intratracheal Dexmedetomidine
* Drug: intratracheal Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients aged from 18 to 60 years old ASA I or II class Undergo elective intraocular surgery Under general anesthesia. Exclusion Criteria: Renal impairment Cardiorespiratory abnormalities Bronchial asthma COPD Restrictive lung diseases Liver failure Allergy to drugs will be used Patient refuse Pregnancy-lactation Significant obesity

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>At the end of the operation by 15min, 5ml saline in a medical spray bottle was sprayed down the intratracheal tube of patients. | Drug: intratracheal saline<br>* At the end of the operation by 15min, 5ml of 0.9% normal saline was sprayed down the intratracheal tube of patients<br>* Other names: Group C;|
| Active Comparator: Dexmedetomidine<br>At the end of the operation by 15min, Dexmedetomidine (0.5µg/kg, diluted in 5mL saline in a medical spray bottle) was sprayed down the intratracheal tube of patients | Drug: intratracheal Dexmedetomidine<br>* At the end of the operation by 15min, Dexmedetomidine (0.5µg/kg, diluted in 5mL saline in a medical spray bottle) was sprayed down the intratracheal tube of patients<br>* Other names: Group D;|
| Active Comparator: Lidocaine<br>At the end of the operation by 15min, (5ml) 2% of lidocaine was sprayed down the intratracheal tube of patients. | Drug: intratracheal Lidocaine<br>* At the end of the operation by 15min, (5ml) 2% of lidocaine was sprayed down the intratracheal tube of patients.<br>* Other names: Group L;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough reflex. | To evaluate efficacy and safety of both dexmedetomidine and lidocaine on Cough: from time of awareness to 5 minute after extubation 0= no cough minimal Cough (single) moderate cough<= 5S severe cough >=5S (bucking) | from time of awareness to 5 minute after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean arterial blood pressure | Perioperative mean arterial blood pressure values were recorded | before anesthesia up to 30 minute after extubation | 
| heart rate | Perioperative heart rate values were recorded | before anesthesia up to 30 minute after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intratracheal, dexmedetomidine, eye-surgery, lidocaine