Propofol and Fentanyl is the commonly used intravenous combination during ERCP to achieve sedation and analgesia. Dexmedetomidine was able to gain popularity in different other types of procedural sedations, and also as an adjunct in anaesthesia practice. The adjunctive role of Dexmedetomidine to other sedative agents was however less studied in prolonged ERCP sedation. Hence a comparative study comparing the two combinations is being conducted.

After approval from the Institutional Ethics Committee, patients who are undergoing ERCP under IV sedation will be included in the study. A thorough pre-anaesthetic evaluation will be done on the pre-operative day. 82 participants satisfying the inclusion criteria will be enrolled in the study after obtaining written informed consent. As per the standard guidelines, patients will be kept nil per oral for 8 hours. Patients will be given premedication with Tab. Alprazolam 0.25 mg and Tab. Pantoprazole 40 mg on the night prior and in the morning at 6 AM on the day of surgery. 

The consultant anaesthetist will decide on the drug combination to be used for sedation based on their preferences. Depending on the combination used, the patients will be divided into two groups (A and B). Patients in group A will receive Fentanyl 1 mcg/kg over 10 min, followed by Propofol loading dose 1-2 mg/kg before the procedure and maintenance infusion at a rate of 1-5 mg/kg/h throughout the procedure maintaining BIS of 60. Group B will receive Dexmedetomidine 1 mcg/ kg over 10 minute, followed by Propofol loading dose 1-2 mg/kg before the procedure and maintenance infusion at a rate of 1-5 mg/ kg/h throughout the procedure maintaining a BIS of 60. preferencesThe observer assessing the sedation and hemodynamic parameters, will not be aware of the drug combination that is given.

On the day of surgery an IV line will be secured and started on maintenance IV fluid with 0.9% normal saline or ringer lactate. All patients will be given Inj. Ondansetron 0.15 mg/kg slow IV for prophylaxis of postoperative nausea and vomiting (PONV) 30 min before procedure.

Pre-procedure antibiotic and NSAID suppositories will be given as a part of ERCP protocol. Patient will then be brought to scopy room, and will be made to lie down on semi-prone position. N{Citation}IBP, ECG, pulse oximeter and BIS monitors will be attached. All baseline parameters will be recorded. Supplemental O₂  will be given to the patients via a nasal cannula at a rate of 2 L/ min. All patients are given Inj Glycopyrrolate (0.2 mg). Patients will be sedated with Propofol-Fentanyl or Propofol-FENTANYL

 combination based on the group to which they are allocated. During the procedure in either groups, if the patient requires more than three episodes of personal restraint by the assistant or if either patient or endoscopist is uncomfortable, or BIS >70, an additional 10-20 mg of Propofol bolus will be administered.

    Induction time will be noted which is the time from the start of bolus dose of drug to the time when BIS value of 60 is achieved. Throughout the procedure vitals and BIS will be monitored. Occurrence of any adverse hemodynamic effects will be noted and managed accordingly. Oxygen desaturation or apnoea (SpO2 <94%) will be managed by bag and mask ventilation, hypotension (decrease in MAP>30%) will be managed by fluid bolus and/or vasopressor (Inj Ephedrine). Bradycardia (HR< 50 beats/min) will be managed with atropine 0.6 mg IV, whereas a HR and MAP more than 30% from the baseline level will be considered as tachycardia and hypertension. Other complications such as coughing, gagging, hiccough, nausea and vomiting will also be recorded. The total duration of the procedure, defined as the time taken from insertion of the endoscope to its removal, will also be documented. 

At the completion of the procedure, the drug infusion will be stopped. Patient’s oropharynx will be thoroughly suctioned turned supine with head up tilt (15 degrees). Patient will be allowed for complete recovery with end points being eye opening on command, ability to handle secretions, follow simple commands, hemodynamic stability, maintaining room air saturation >95% and attainment of BIS value >90.Recovery time is recorded from the cessation of drug infusion till BIS score reaches ≥ 90. The patient will be shifted to the recovery room when the BIS score is ≥90 and when Modified Aldrete score becomes ≥9. All patients’ experience relating to the procedure and anaesthesia will be recorded. They are asked about the level of satisfaction. Post-operative pain (VAS score) and occurrence of PONV are noted.