Effect of Intravenous Lidocaine and Dexamethasone Combination on Postoperative Sore Throat, Cough and Hoarseness.

Study Overview
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Brief Summary
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Post operative sore throat (POST) following tracheal intubation is a common problem causing dissatisfaction and discomfort to the patients. Prophylactic use of both lidocaine and dexamethasone has been used independently for this purpose. However, there is no study assessing the synergistic analgesic effects of lidocaine and dexamethasone for POST. The purpose of this study is to compare the effect of lidocaine, dexamethasone and lidocaine dexamethasone combination on the incidence and severity of POST.

Detailed Description
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Sore throat and hoarseness following tracheal intubation are common postoperative problems causing dissatisfaction and discomfort to the patients. Their incidence varies from 30%-70%. Both non pharmacological and pharmacological measures have been tried to minimize the incidence and severity of POST with variable success rate. Prophylactic use lidocaine and steroids have been used independently for this purpose. Dexamethasone as an adjuvant to lidocaine has shown to improve the quality of analgesia. However, there is no study assessing the combine effects of lidocaine and dexamethasone for POST.

Official Title
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Combined Effect of Intravenous Lidocaine and Dexamethasone on Postoperative Sore Throat, Cough and Hoarseness. A Randomized Controlled Trial

Conditions
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Postoperative Sore Throat, Cough, Hoarseness

Intervention / Treatment
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* Drug: LD: Lidocaine and dexamethasone
* Drug: L:Lidocaine
* Drug: D: Dexamethasone
* Drug: N: Normal saline (placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of American Society of Anesthesiologist(ASA) physical status 1 & 2 requiring general anesthesia with endotracheal intubation. Duration of surgery more than 90 min Exclusion Criteria: Those with preexisting hoarseness or sorethroat Smoker Vocal performer by occupation Recent or recurrent respiratory tract infection Risk factors for postoperative aspiration Obesity Pregnancy Receiving analgesics, corticosteroids and calcium channel blockers Contraindication to corticosteroid medications Anticipated difficult intubation Mallampati grade > 2 Difficult mask ventilation requiring oral or nasal airway Cormack and Lehman grade III and IV on laryngoscopy More than one intubation attempt Those requiring orogastric or nasogastric tubes

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group LD: Lidocaine and Dexamethasone<br>lidocaine 1.5 mg/kg and dexamethasone (dexona) 8 mg iv prior to induction of anesthesia | Drug: LD: Lidocaine and dexamethasone<br>* LD: intravenous lidocaine 1.5 mg/kg and dexamethasone 8 mg before induction of anesthesia<br>* Other names: Xylocard, dexona;|
| Active Comparator: Group L: Lidocaine<br>Group L: lidocaine 1.5 mg/kg iv prior to induction of anesthesia | Drug: L:Lidocaine<br>* Intravenous lidocaine 1.5 mg/kg before induction of anesthesia<br>* Other names: Xylocard;|
| Active Comparator: D: Dexamethasone<br>Dexamethasone 8 mg iv prior to induction of anesthesia | Drug: D: Dexamethasone<br>* D:intravenous dexamethasone 8 mg before induction of anesthesia<br>* Other names: Dexona;|
| Placebo Comparator: N: normal saline<br>N: normal saline (placebo): 2 ml | Drug: N: Normal saline (placebo)<br>* Normal saline: 2ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of postoperative sore throat at rest and on swallowing. | Incidence of postoperative sore throat. Assessment of severity of postoperative sorethroat using scoring system, 0-No sore throat at any time since the operation,1- Minimal sore throat,2- Moderate sore throat,3- Severe sore throat | From 1 to 24 hr following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -Assessment of post operative cough. Assessment of post operative cough using scoring system,0- No cough,1- Minimal cough,2- Moderate cough,3- Severe cough. | -Assessment of postoperative hoarseness. Assessment of postoperative hoarseness using scoring system,0- No evidence of hoarseness at any time since the operation,1-No evidence of hoarseness at the time of interview,2-Hoarseness at the time of interview noted by patient only, 3- Hoarseness that is easily noted at the time of interview | From 1 to 24 hr following surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lidocaine, Dexamethasone, Postoperative sore throat