Intravenous Dexmedetomidine versus Nebulised Dexmedetomidine in combination with standardised Propofol-Fentanyl-Midazolam for Procedural sedation during ERCP: a comparative evaluation of sedation efficacy

to compare the sedative efficacy of IV dexmedetomidine and nebulized dexmedetomidine when combined with standard propofol-fentanyl-midazolam during Endoscopic retrograde pancreticochalaniography

Randomised, inferiority, single-blind with blinding of outcome assessor, single centre, randomised controlled trial

1. Randomly allocated into two groups using a generated random number table and concealed envelopes for sharing random allocation. 2. Dexmedetomidine administration as per group allocation will be done in the pre-procedure room and the mode of administration will not be known to the outcome assessor during the Endoscopic procedure under sedation. 5. All patients will receive midazolam(.01mg/kg) and fentanyl (1 mcg/kg) for anaesthesia induction based on ideal body weight. In both groups, anaesthesia will be maintained with continuous infusion of propofol @ 100 – 200 mcg/kg/min. If required 10 mg propofol iv bolus will be given to maintain Ramsay Sedation Scale 4

INCLUSION CRITERIA 1.Patients undergoing elective/emergency ERCP procedures under sedation 2. Age between 18-65 years 3. ASA grades I-III EXCLUSION CRITERIA 1. Patient refusal 2. Allergy to drug 3. Heart rate < 50 beats/min, 4. Beta-blockers 5. Shock 6. Oxygen saturation(SpO2) less than 90%, 7. Cardiomyopathy 8. Kidney or hepatic insufficiency. 9. Second or third-degree heart block, 10. Body mass index (BMI) over 36 kg/m2

1. Group NEB-DEX: Nebulized dexmedetomidine 1 µg/kg diluted in normal saline (0.9%) to a volume of 5 ml 30 minutes before induction of anaesthesia and 2. Group IVDEX: IV dexmedetomidine 1 mcg/kg diluted in normal saline over 10 minutes 30 minutes before induction of anaesthesia.

Propofol consumption per unit time ( mg/min)

1. A list of participants will be created in spreadsheet/excel sheet 2. Generate random numbers in next column using excel formula. 3. Sort the list based on the random numbers. 4. Assign the first half of participants to Group A and the second half to Group B. 5. Sealed envelop with serial numbers on it with allocation sealed inside, will be applied to ensure blinding and confidentiality of group assignment.

The administration of intravenous and nebulised Dexmedetomidine is done by different personnel neither involved in study nor procedure sedation to prevent bias. Randomly assign participants to either the intravenous or nebulised Dexmedetomidine group using a randomization table or software. Administration of medication will be done in pre op area. Anaesthesia management will be done by anaesthesiologist not related to study, using Midazolam- Fentanyl- Propofol combination. All parameters/outcome will be recorded by caregiver anaesthesiologist in proforma. Investigator will collect proforma at the end of procedure for data extraction and analysis.