Preoperative Aspirin and Benzydamine Hydrochloride Gargles on Severity and Duration of Post-Operative Sore Throat

Phase

Condition

Pharyngitis

Treatment

N/A

Clinical Study ID

NCT05343429

RMI/RMI-REC/Approval/122

Ages 18-60
Female
Accepts Healthy Volunteers

Study Summary

Post-operative sore throat (POST) following General Anesthesia with endotracheal is a common symptom and drains resources. The researchers will compare preoperative gargling of Asprine and Benzydamine HCL to study comparative effects on intensity and duration of POST. Data collected as such will be analyzed to reach at a conclusion.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients of American Society of Anesthesiologists Class 1 and 2 (ASA 1 and 2)scheduled for gynecological surgery under General Anesthesia with Intra trachealIntubation and expected to finish in less than three hours will be included in thestudy.
Patients of 18- 60 years of age will be included.
Patients of Mallampati class 1 and 2 will be selected, as these have easy intubationpredicted.
Patients qualifying for easy intubation (prediction based on mouth opening, neckmobility etc.) will be selected.
Patients in supine position only.

Exclusion

Exclusion Criteria:

Patients who are unable to gargle properly.
Patients who require more than 2 attempts at intubation.
Patients of Cormack-Lehane Grade 3 and 4 on direct laryngoscopy (multiple intubatingattempts may be required).
Patients requiring oral cavity instrumentation e.g. N/G tube placement, oral orlaryngeal surgeries including tonsillectomies
Patients whose head are frequently turned > 90 degrees with ETT placed in.
Patients whose surgery is prolonged beyond 3 hour.
Patients who require postoperative mechanical ventilation.

Study Design

April 01, 2022

December 31, 2022

Study Description

Endotracheal intubation commonly causes postoperative sore throat (POST). Its incidence is 22

62% in the adult population whereas in children the incidence is 24 to 44%. In adult population peak incidence is 2 to 4 hours after tracheal extubation. There is a limited medical literature available about incidence and peak time of occurrence after tracheal extubation in children. Though relieved in due course of time, POST leads to postoperative dissatisfaction. Traumatic laryngoscopy and endotracheal tube residence are the most likely offenders individually or combined. Other risk factors include preexisting upper respiratory tract infection, multiple intubation attempts, intubating un-paralyzed patient, high ETT cuff pressure, prolonged anesthesia with ETT and inexperienced operator.

The problem i.e. POST preemptive amelioration, has been studied using various pharmacological interventions. The list includes, but is not limited to, Benzydamine hydrochloride, aspirin, ketamine, lidocaine and dexamethasone. In a study conducted by Agarwal A, Nath SS, Goswami D et al on adult female patients employing preoperative Aspirin and Benzydamine hydrochloride gargling found it simple, safe and effective method in reducing incidence and severity of POST. Their patients were scheduled for mastectomy. However, a study conducted by Hyung-Been Yhim, Soo-Hyuk Yoon, Young-Eun Jang et al in pediatrics was unsuccessful to show reduction in POST when they used Benzydamine hydrochloride (BH) spray on vocal cords and upper airway before tracheal intubation. They asked for more research and suggested well-designed and powered RCT's in children. The current study will differ from previously conducted research and will include adult males of different ethnicity and type of surgery.

Objectives: To compare the effect of Aspirin and Benzydamine hydrochloride (BH) gargles on incidence, severity and duration of POST.

Connect with a study center

Rehman Medical Institute
Peshawar, Khyber Pakhtunkhwa 25000
Pakistan
Active - Recruiting

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