Introduction: Moderate to deep sedation is generally used for endoscopic retrograde cholangiopancreatography (ERCP). The depth of sedation is usually judged by clinical assessment and electroencephalography-guided monitoring. The aim of this study was to compare the clinical efficacy of clinical assessment and Narcotrend(TM) monitoring during deep-sedated ERCP.
Methods: One hundred patients who underwent ERCP in a single year were randomly assigned to either group C or group N. Patients in group C (52) were sedated using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. Patients in group N (48) were sedated using the Narcotrend(TM) system. The MOAA/S scale 1 or 2 and the Narcotrend(TM) index 47-56 to 57-64 were maintained during the procedure. The primary outcome variable of the study was the successful completion of the endoscopic procedure. The secondary outcome variables were the total dose of propofol used during the procedure, complications during and immediately after procedure, and recovery time.
Results: All endoscopies were completed successfully. The mean total dose of propofol in group C was significantly lower than that in group N. However, the mean dose of propofol, expressed as dose/kg or dose/kg/h in both groups, was not significantly different (P = 0.497, 0.136). Recovery time, patient tolerance and satisfaction, and endoscopist satisfaction were comparable between the two groups. All sedation-related adverse events during and immediately after the procedure, such as hypotension, hypertension, tachycardia, bradycardia, transient hypoxia, and upper airway obstruction, in group C (62.2%) were significantly higher than in group N (37.5%) (P = 0.028).
Conclusion: Clinical assessment and Narcotrend(TM)-guided sedation using propofol for deep sedation demonstrated comparable propofol dose and recovery time. Both monitoring systems were equally safe and effective. However, the Narcotrend(TM)-guided sedation showed lower hemodynamic changes and fewer complications compared with the clinical assessment-guided sedation.
Keywords: NarcotrendTM monitoring; clinical assessment; deep sedation; endoscopic retrograde cholangiopancreatography.