Effect of Intravenous Lidocaine and Dexamethasone Combination on Postoperative Sore Throat, Cough and Hoarseness.
Information source: B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Sore Throat, Cough, Hoarseness
Intervention: LD: Lidocaine and dexamethasone (Drug); L:Lidocaine (Drug); D: Dexamethasone (Drug); N: Normal saline (placebo) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: B.P. Koirala Institute of Health Sciences Official(s) and/or principal investigator(s):
Asish Subedi, MD, Principal Investigator, Affiliation: BPKIHS
Overall contact:
Asish Subedi, MD, Phone: 977-25-525555, Ext: 2013, Email: subediasish@yahoo.com
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.
Clinical Details
Official title: Combined Effect of Intravenous Lidocaine and Dexamethasone on Postoperative Sore Throat, Cough and Hoarseness. A Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Assessment of postoperative sore throat at rest and on swallowing.
Secondary outcome: -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.
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Asish Subedi, MD, Phone: 977-25-525555, Ext: 2013, Email: subediasish@yahoo.com
BP Koirala Institute of Health Sciences (BPKIHS), Dharan, Koshi 56700, Nepal; Recruiting
Asish Subedi, MD, Phone: 977-25-525555, Ext: 2013, Email: subediasish@yahoo.com
Asish Subedi, MD, Principal Investigator
Additional Information
Starting date: April 2013
Last updated: January 27, 2015
|
