Postoperative Sore Throat, Cough, Hoarseness Clinical Trial
Official title:
Combined Effect of Intravenous Lidocaine and Dexamethasone on Postoperative Sore Throat, Cough and Hoarseness. A Randomized Controlled Trial
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.
| Status | Completed |
| Enrollment | 180 |
| Est. completion date | January 2016 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Nepal | BP Koirala Institute of Health Sciences (BPKIHS) | Dharan | Koshi |
| Lead Sponsor | Collaborator |
|---|---|
| B.P. Koirala Institute of Health Sciences |
Nepal,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | -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 | Yes |