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A study to compare the efficacy of the drug dexamethasone and lidocaine when used before surgery as inhalation to prevent post operative sore throat

Phase 4
Completed
Conditions
Other surgical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure,
Registration Number
CTRI/2023/11/060109
Lead Sponsor
Department of Anaesthesiology
Brief Summary

Postoperative sorethroat (**POST**) is a common adverseevent after general anesthesia especially with endotracheal intubation.Reported incidence of POST following general anesthesia is variable and rangesbetween 20-74%[1]. Aetiology is multifactorial which includespatient-related factors such as age, sex, smoking; and intubation factorsincluding technique, duration, number of attempts, tube size,intracuffpressure, cuff design, intraoperative tube movement, airwaymanipulations, and suctioning[2]. Mucosal damage by mechanical injurydue to airway manipulation and dehydration of the orophyrangeal mucosa areconsidered to result in post-operative sore throat . Postoperative sorethroat (**POST**) is a common adverseevent after general anesthesia especially with endotracheal intubation.Reported incidence of POST following general anesthesia is variable and rangesbetween 20-74%[1]. Aetiology is multifactorial which includespatient-related factors such as age, sex, smoking; and intubation factorsincluding technique, duration, number of attempts, tube size,intracuffpressure, cuff design, intraoperative tube movement, airwaymanipulations, andsuctioning[2]. Mucosal damage by mechanical injurydue to airway manipulation and dehydration of the orophyrangeal mucosa areconsidered to result in post-operative sore throatPostoperative sorethroat (**POST**) is a common adverseevent after general anesthesia especially with endotracheal intubation.Reported incidence of POST following general anesthesia is variable and rangesbetween 20-74%[1]. Aetiology is multifactorial which includespatient-related factors such as age, sex, smoking; and intubation factorsincluding technique, duration, number of attempts, tube size,intracuffpressure, cuff design, intraoperative tube movement, airwaymanipulations, and suctioning[2]. Mucosal damage by mechanical injurydue to airway manipulation and dehydration of the orophyrangeal mucosa areconsidered to result in post-operative sore throat.

**Pharmacological** measures for attenuatingPOST include use of topical, intravenous or inhalational agents.Variouspharmacological agents such as  ketamine,benzydamine hydrochloride, lignocaine, magnesium and corticosteroids are usedto prevent POST. Locally used agents reduce airway inflammation by activeanti-inflammatory and analgesic properties when used preemptively and haveminimal systemic side effects.

In recent yearsnebulization with different drugs for POST have been used preoperatively andstudies have shown a reduction in the incidence and severity of POST. Due tosparing of bitter taste nebulization are better accepted and tolerated by thepatients. Requirement of small volume of drugs for effect, easy way ofadministration, better patient compliance, and very less risk of adverse eventsmakes nebulization therapy preferred choice over other methods such as gargle,intravenous etc

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
135
Inclusion Criteria

Adult patients of ASA physical status I and II, age between 18 and 60 years of either sex, undergoing elective surgeries in supine position under General Anaesthesia with endotracheal intubation lasting < 3 hours will be enrolled in the study.

Exclusion Criteria
  • Patients with recent sore throat(<14days) Patients with history of recent(<14days) use of steroids or NSAIDS.
  • Pregnant patients.
  • Patients with present chronic airway disease.
  • Anticipated difficult airway.
  • Patient refusal.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The incidence of Postoperative sore throat at 4 hours post extubationThe incidence of Postoperative sore throat at 4 hours post extubation
Secondary Outcome Measures
NameTimeMethod
Incidences & severities observed at 2 4 8 12 & 24 hours post surgery on a four point scale forAny hoarseness of voice

Trial Locations

Locations (1)

PT. BDS PGIMS Rohtak

🇮🇳

Rohtak, HARYANA, India

PT. BDS PGIMS Rohtak
🇮🇳Rohtak, HARYANA, India
Dr Rahul Dayora
Principal investigator
9991540213
rahulprazapati@gmail.com

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