1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [geetamanojkamal@gmail.com].
   


6. For how long will this data be available start date provided 26-09-2023 and end date provided 26-06-2028?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Pre-anesthetic evaluation with detailed history, physical examination, and routine investigations will be done for all the patients. Well-informed written consent will be obtained from all the patients. All patients will be premedicated with tab Alprazolam 0.5 mg the night before surgery, tab Ranitidine 150 mg, and a tab Ondansetron 4 mg in the morning 2 hours before the surgery. After shifting the patient to the procedure room, ASA standard monitors will be connected and baseline electrocardiography (ECG), heart rate (HR), noninvasive blood pressure. (NIBP) and Oxygen Saturation (SpO2) will be taken. An IV line will be secured with an 18G Cannula and 500ml Ringer lactate will be started, Patency of both nostrils will be tested and the nostril with better patency will be chosen for Awake Nasal Fiberoptic Intubation. Inj. Glycopyrrolate 0.2 mg IV and intranasal xylometazoline 0.1%, nasal drops will be given in both nostrils prior to nebulization in every patient.  

RANDOMIZATION                     

The patients will inhale the nebulized solution from the nebulizer in a semi-reclining position in the procedure room. The patients will be randomly assigned into two groups based on a computer-generated randomization sequence. The two groups will be as follows:

i.              Group LD: Patients will be nebulized with dexmedetomidine 2 mcg/kg (diluted with normal saline (NS) to make a total volume of 2 mL) plus 4 ml of 4%(160mg) lignocaine (total vol. 6ml).

ii.            Group LS: Patients will be nebulized with 4 ml 0f 4% (160mg) lignocaine plus 2 ml of normal saline (NS) (total vol. 6ml).

All the patients will be nebulized over a period of 20 min as per group allocation. At the end of nebulization, adverse effects like signs of lignocaine toxicity, and the level and quality of sedation will be assessed using the Ramsay sedation score. Premedication inj. Fentanyl 2 microgram/kg IV will be given before AFOI. Oropharynx and Hypopharynx will be sprayed with two puffs of 10% lidocaine (each depression of release button delivered 0.1 mL=10 mg, 2puffs = 20mg). The patients will be received supplemental oxygen (2 lit/min) therapy via nasal prong. A well-lubricated fiberoptic bronchoscope preloaded with an appropriate size cuffed endotracheal tube will be inserted through the nostril in the patient lying in the supine position. If a cough reflex will present during FFB, the spray as you go technique will be used as a supplementary LA technique when the patient has partial pharyngeal or transtracheal anesthesia. In this method, a quick pulse of 2 ml 2 % lidocaine will be injected through the working channel of the fiberoptic bronchoscope when the tip of the bronchoscope reaches areas with insufficient anesthesia. In case of cough and gag reflexes still present during FFB If the patient tolerance score during the procedure was 3 or if the anesthesiologist will uncomfortable, an additional sedative in the form of intermittent incremental doses of Propofol 20 mg IV will be given in either of the groups to subside the reflexes, during AFOI procedure, vitals parameters like HR, MAP, and SPO2 will be monitored at 0 min (baseline), 10 min after nebulization, 20 min after nebulization every minute for first 5 minutes, immediately after intubation, followed by every 5 minutes after AFOI for first 20 minutes, and throughout the procedure and the lowest reading will be noted. After proper placement of ETT in the trachea, general anesthesia will be induced and surgery will be allowed to proceed