Comparing the Efficacy of Benzydamine and Magnesium Sulphate Oral Gargle for Treating Postoperative Sore Throat in Patients Undergoing breast surgeries – A phase 2 randomised study
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- To study the difference in proportion of patients with reduction in POST score less than 2 assessed by four point scale between Benzydamine and magnesium sulphate oral gargle.
Study Overview
Brief Summary
Postoperative sore throat (POST) is a common and distressing complication following endotracheal intubation during surgery with an incidence ranging from 14% to 63%. Multiple studies have been done for prevention of sore throat after tracheal intubation using topical agents such as lignocaine, steroids, benzydamine, magnesium sulphate, ketamine, dexmedetomidine and nonpharmacological measures like cuff pressure maintenance, avoidance of N2O, smaller tracheal tubes. Topical benzydamine hydrochloride and magnesium sulphate application has significantly reduced the sore throat incidence upto 24 hours with no major complications. There is paucity of literature or publications regarding the management of POST. Most of the studies discuss prevention of sore throat using topical solutions. Currently no standard treatment guidelines exist for managing postoperative sore throat. Most often it is neglected or managed conservatively using saline nebulisation and reassurance. When comparing saline nebulization to other topical agents, studies generally show that saline nebulization alone does not significantly reduce the incidence or severity of POST. Addressing POST will help improving the overall quality of anaesthesia care. There are no studies to validate the superiority or inferiority between magnesium and benzydamine oral gargle. This study is an attempt to assess the feasibility of application of these two agents in managing postoperative sore throat in patients undergoing breast surgeries under general anaesthesia.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Adult female patients aged more than 18 years.
- •POST GRADE more than or equal to 2 within 48 hours after surgery.
- •Patients Undergoing elective breast surgeries under general anaesthesia with endotracheal intubation complaints of sore throat.
- •ASA classification 1 to 3.
Exclusion Criteria
- •Patients having Known allergy to benzydamine or magnesium sulphate Asthmatic patients on steroid nebulisation.
- •Patients with History of respiratory tract infection within 1 week before surgery.
- •Patients with History of gastroesophageal reflux disease (GERD) or oral ulcers.
- •Patients unable to perform oral gargling.
- •Patient refusal patients who are not extubated at the end of surgery.
Outcomes
Primary Outcomes
To study the difference in proportion of patients with reduction in POST score less than 2 assessed by four point scale between Benzydamine and magnesium sulphate oral gargle.
Time Frame: 6 hours after the intervention
Secondary Outcomes
- To evaluate difference in the duration of effect of the intervention between benzydamine and magnesium sulphate oral gargle as defined by recurrence of POST grade 2 or more after an initial response to the intervention.(• To study the difference in proportion of patients with reduction in POST score less than 2 assessed by 4 point scale between Benzydamine and magnesium sulphate oral over 24 hours after the intervention.)