Role of dexamethasone in nebulized versus intravenous route in prevention of post operative sore throat

Phase 4

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/05/052307
• Lead Sponsor: Kasturba Medical Colleges

Brief Summary

Sore throat is a common postoperative complaint occuring in adults in the post operative period following general anesthesia. Postoperative sore throat can result in cough which can cause strain and increased pain at surgical site . Several pharmacological and non pharmacological methods have been tried to decrease the incidence and severity of post operative sore throat. Dexamethasone is a potent corticosteroid with anti-inflammatory property. In this study we compare the effectiveness of intravenous versus nebulized dexamethasone in preventing post operative sore throat with the least undesirable effects .In this study patients will be assessed a day prior to surgery during the preanesthetic checkup and the patients who will fulfil the inclusion criteria will be included in the study. The randomization will be done by using a computer-generated random number table and the patient will be allocated into one of the three groups. In the first group patient will receive intravenous dexamethasone (0.2mg/kg of body weight) half an hour before induction of anesthesia. The second group will be given nebulization with dexamethasone (0.2mg/kg of body weight with 3ml of NS) half an hour before induction of anesthesia. The third group will be a control group who will not be given either intravenous or nebulized dexamethasone. All patient taken up for surgery will be premedicated as per standard protocol. On the day of the surgery, patient will be taken to pre operative area where noninvasive blood pressure, pulse oximeter would be attached and vitals will be noted. Preoperatively GRBS will also be noted while securing intravenous cannula. Patient will be nebulized with dexamethasone or be given intravenous dexamethasone according to randomization 30 min prior to induction. The patient will be then shifted to operation theatre and standard ASA monitors will be attached. Anesthesia will be induced according to the respective anesthetist discretion.. Airway will be secured with PVC portex tubes of appropriate sizes (size of 7mm and 8mm internal diameter for females and males respectively) . The Cormack- Lehane grade would be noted in all patient during laryngoscopy , patient with grade IIb and above would be excluded. The cuff would be inflated with room air and cuff pressure would be kept at 25 -30 cms of water intraoperatively .The ETT tube placement would be confirmed with the appearance of square wave end tidal capnography. Anesthesia would be maintained with isoflurane (1-1.5%)in oxygen- air mixture. Mechanical ventilation would be adjusted to maintain partial pressure of carbon dioxide between 30- 35mmHg. Cuff pressure would be monitored with cuff manometer every 30 min and would be maintained at 25 –30 cms of water. Paracetamol infusion of 15mg/kg and fentanyl boluses will be administered for intraoperative pain. For post-operative pain all patients will receive paracetamol infusion of 15mg/kg 8th hourly. At the end of the surgery, gentle oral suctioning would be done and anesthesia would be reversed with glycopyrrolate 0.01mg/kg and neostigmine 0.05mg/kg. Any cough/ blood over the ET tube during extubation will be noted. Pre extubation GRBS will be noted to rule out any systemic absorption causing increase in blood sugars.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-05
• Study Completion: 2024-12-07
• Last Update Posted: 2024-12-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

•Adult patient aged 18-60 years of either gender •ASA PS grade I/ II scheduled to undergo surgery requiring general anesthesia with duration less than 3hrs.

Exclusion Criteria

• Patient with anticipated difficult airway 2.
• Patient on steroids 3.
• Patient on recent history URTI/ LRTI 3.patient requiring more than 2 attempts during intubation 4.patients with history of diabetes mellitus 5.
• Head neck surgeries 6 Patient in whom Dexamethasone is from surgical side contraindicated.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of post operative sore throat .	Presence of sore throat and grading will be done at 12 hrs , 24 hrs and 48 hrs

Secondary Outcome Measures

Name	Time	Method
1. To note the presence of cough and hoarseness of voice2. Pre and post operative blood sugar levels

Trial Locations

Locations (1)

Kasturba Medical College Manipal; 🇮🇳 Udupi, KARNATAKA, India

Kasturba Medical College Manipal

🇮🇳Udupi, KARNATAKA, India

Debahuti Chatterjee

Principal investigator

7063279142

chatterjeedebahuti@gmail.com