A comparative study of sedation and respiratory effects during endoscopic retrograde cholangiopancreatography with propofol fentanyl versus dexmedetomidine ketamine

This prospective observational study aims to compare the sedation and respiratory effects of two intravenous sedative regimens that is, Propofol Fentanyl versus Dexmedetomidine Ketamine, in adult patients undergoing Endoscopic Retrograde Cholangiopancreatography or ERCP at KEM Hospital, Mumbai.

ERCP is a complex, prone positioned gastrointestinal procedure that requires deep sedation to suppress airway reflexes and ensure patient immobility. Traditionally, Propofol combined with Fentanyl is used, offering rapid onset and recovery but often associated with respiratory depression and haemodynamic instability. Alternatively, the Dexmedetomidine and Ketamine combination offers a favourable safety profile as dexmedetomidine provides sedation and analgesia with minimal respiratory depression, while ketamine preserves airway reflexes and counters haemodynamic side effects.

The study will include 80 adult patients belonging to ASA I and II category, aged 18 to 65 years, with BMI less than 35, and will exclude patients with sleep apnoea, significant respiratory disease, pregnancy, or drug allergies. Patients will receive oxygen via nasal cannula, and be monitored using standard ASA parameters along with end tidal CO2 etCO2 for real time ventilation assessment. Parameters like heart rate, mean arterial pressure MAP, oxygen saturation SpO2, sedation depth by the Ramsay Sedation Scale, recovery by the Modified Aldrete Score, pain by the Numeric Rating Scale, and adverse events for example, hypoventilation, apnoea, desaturation, hypotension, bradycardia etcetera will be recorded at defined intervals intra procedure and post procedure.

The primary objective is to compare sedation and respiratory outcomes SpO2, etCO2 between the Propofol Fentanyl and Dexmedetomidine Ketamine groups. Secondary objectives include comparing haemodynamic stability, time to achieve desired sedation depth, recovery time, pain scores, and adverse event rates.

Statistical analysis will involve chi square test, Fischer’s exact test and for means of more than two groups, one way ANOVA test. Significance is set at p less than 0.05.

The study aims to determine which regimen provides safer, more effective sedation with fewer complications during ERCP, ultimately guiding optimal anaesthetic practice for this high risk procedure.