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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01990781
Enrollment
180
Registered
2013-11-21
Start date
2013-12-31
Completion date
2016-01-31
Last updated
2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Sore Throat, Cough, Hoarseness

Keywords

Lidocaine, Dexamethasone, Postoperative sore throat

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.

Interventions

DRUGLD: Lidocaine and dexamethasone

LD: intravenous lidocaine 1.5 mg/kg and dexamethasone 8 mg before induction of anesthesia

Intravenous lidocaine 1.5 mg/kg before induction of anesthesia

DRUGD: Dexamethasone

D:intravenous dexamethasone 8 mg before induction of anesthesia

DRUGN: Normal saline (placebo)

Normal saline: 2ml

Sponsors

B.P. Koirala Institute of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of postoperative sore throat at rest and on swallowing.From 1 to 24 hr following surgeryIncidence 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

MeasureTime frameDescription
-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

Countries

Nepal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026