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

B.P. Koirala Institute of Health Sciences

Status and phase: Completed; Phase 4

Conditions: Postoperative Sore Throat, Cough, Hoarseness

Treatments: Drug: D: Dexamethasone; Drug: L:Lidocaine; Drug: LD: Lidocaine and dexamethasone; Drug: N: Normal saline (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT01990781

387/070/071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 4 patient groups, including a placebo group

Group LD: Lidocaine and Dexamethasone

Experimental group

Description:

lidocaine 1.5 mg/kg and dexamethasone (dexona) 8 mg iv prior to induction of anesthesia

Treatment:

Drug: LD: Lidocaine and dexamethasone

Group L: Lidocaine

Active Comparator group

Description:

Group L: lidocaine 1.5 mg/kg iv prior to induction of anesthesia

Treatment:

Drug: L:Lidocaine

D: Dexamethasone

Active Comparator group

Description:

Dexamethasone 8 mg iv prior to induction of anesthesia

Treatment:

Drug: D: Dexamethasone

N: normal saline

Placebo Comparator group

Description:

N: normal saline (placebo): 2 ml

Treatment:

Drug: N: Normal saline (placebo)