Clinical trial NCT01990781: Effect of Intravenous Lidocaine and Dexamethasone Combination on Postoperative Sore Throat, Cough and Hoarseness.
Official title: Combined Effect of Intravenous Lidocaine and Dexamethasone on Postoperative Sore Throat, Cough and Hoarseness. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Sore Throat, Cough, Hoarseness
Keywords: Lidocaine, Dexamethasone, Postoperative sore throat
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of postoperative sore throat at rest and on swallowing.
timeFrame: From 1 to 24 hr following surgery
Secondary outcomes:
measure: -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.
timeFrame: From 1 to 24 hr following surgery
Other outcomes:
Locations:
city: Dharan
country: Nepal
facility: BP Koirala Institute of Health Sciences (BPKIHS)
state: Koshi
Study officials:
affiliation: BPKIHS
name: Asish Subedi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Subedi A, Tripathi M, Pokharel K, Khatiwada S. Effect of Intravenous Lidocaine, Dexamethasone, and Their Combination on Postoperative Sore Throat: A Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):220-225. doi: 10.1213/ANE.0000000000003842.