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

Phase 4

Completed

• Conditions: Postoperative Sore Throat, Cough, Hoarseness

• Registration Number: NCT01990781
• Lead Sponsor: B.P. Koirala Institute of Health Sciences

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-11-02
• Study First Submitted QC: 2013-11-16
• Study First Posted: 2013-11-21
• Study Start: 2013-12
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-04
• Last Update Posted: 2016-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of postoperative sore throat at rest and on swallowing.	From 1 to 24 hr following surgery	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

Secondary Outcome Measures

Name	Time	Method
-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.	From 1 to 24 hr following surgery	-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

Trial Locations

Locations (1)

BP Koirala Institute of Health Sciences (BPKIHS); 🇳🇵 Dharan, Koshi, Nepal