To determine the efficacy of dexmedetomidine and dexamethasone nebulisation in preventing sore throat in patients undergoing general anesthesia: A randomised double blind comparative study

Methodology of Study

After obtaining institutional ethical committee approval, a randomized comparative

study will be carried out.

A written and informed consent will be taken from the patient after explaining the

purpose, the procedure and risks involved with the study.

63 patients of ASA 1 and ASA 2 aged between 18 and 60 years scheduled for elective

surgeries under general anaesthesia will be selected based on inclusion or exclusion

criteria as mentioned above.

All patients will be subjected to detailed preanesthetic evaluation. Routine and specific

investigations will be done as per patients clinical evaluation along with optimization.

All patients will be evaluated a day before the surgery. Patients will be kept NPO as per

the ASA guidelines before the procedure.

Eligible patients will be randomly allocated using computer formulated randomization

technique and opaque sealed envelopes by anesthesiology technician who will not take

part in the study. After opening those envelopes, the nebulization solution will be

prepared by anesthesia assistant (who will not take part in the study) according to the

assigned group.

GROUP A- Patient will receive nebulization dexmedetomidine 50 mcg/ml mixed with

4ml normal saline to a total volume of 5ml given over 15 minutes

GROUP B- patient will receive nebulization dexamethasone 8mg (2ml) mixed with

normal saline to a total volume of 5ml given over 15 minutes

GROUP C- patient will receive nebulisation with normal saline 5ml given over 15mins

Patients will be unaware of their treatment as the nebulized substances are colorless,

odourless and tasteless.

Upon arrival at the operating room’s waiting area, patients will undergo re-examination

for identification, diagnosis and intravenous access. The drug will be delivered using

nebulization mask that will last for 15minutes with the help of a wall attached oxygen

driven source (8L, 50psi) according to the respective treatment group.

Heart rate, blood pressure and oxygen saturation will be recorded before and every

3 minutes during nebulization. Presence of bradycardia, hypotension, respiratory

depression, and sedation will be noted.

After 15minutes of nebulization, patient will be shifted to OT and standard ASA monitors

will be attached. Patient will be induced with fentanyl 2 µg/kg, propofol 2 mg/kg and

vecuronium 0.1mg/kg. A Senior Anesthesiologist will perform intubation via direct

laryngoscopy. The ETT cuff will be inflated with air to 20-25 cmH2O pressure with a

sterile single lumen cuffed polyvinyl chloride (PVC) validated with a manometer and

connected to the anesthesia machine. ETT size, laryngoscopy duration and blood on

laryngoscope blade will be documented. Intracuff pressure will be monitored every

30minutes to maintain 20-25 cm H20 pressure. Anaesthesia will be maintained using

33% oxygen in Nitrous oxide and Isoflurane.

Once the surgery is completed, the oropharynx will be gently suctioned using a soft

suction catheter and patient will be assessed for extubation and reversed with IV

Neostigmine 50mcg/kg and IV Glycopyrrolate 10mcg/kg. Data of patients going into

mechanical ventilation post- operative will be excluded from the study.

Ondansetron will be administered to prevent postoperative nausea and vomiting

(PONV)as per the hospital guidelines .

Hemodynamic data will be assessed before intubation, 1 min after intubation, and every

3 min for the first 15 min post-intubation. During surgery, vitals will be recorded every

15 minutes. Following surgery, vitals will be recorded in PACU. Any side effects will be

recorded for 24 hours post extubation. Post operative cough will be graded as follows:

0- No cough of any time since the operation, 1- Minimum,2- Moderate, 3- Severe.

Post operative hoarseness of voice will be graded as follows: 0- No complaint of

hoarseness at any time since the operation,1- Minimal, 2-Moderate,3 - Severe

POST evaluation will be conducted at 0, 2, 6,12, and 24 hours after surgery, utilizing a

four-point scale will be done by a PACU nursing staff who will be oblivious to the group

allocated to the patient

• 0- NIL

• 1- Mild sore throat (sore throat only when asked)

• 2- Moderate sore throat (sore throat even without asking)

• 3- Severe sore throat (change of voice or hoarseness with throat pain).

If moderate or severe POST persists even after 24 hours, lukewarm saline gargle and

decongestants will be started. Whoever has persistent

symptoms, an Oto-rhino-laryngologist consultation will be done.