Objective  To explore the efficacy and safety of oxycodone and midazolam for endoscopic retrograde cholangio-pancreatography (ERCP) under awake sedation.

Methods  Patients scheduled for elective ERCP in the department of gastroenterology of Xuzhou Central Hospital from January 2021 to December 2022 were prospectively recruited and randomly divided into the control group (pethidine combined with diazepam) and the experimental group (oxycodone combined with midazolam). Visual Analogue Scale (VAS) score, Ramsay Sedation Scale (RSS) score, heart rate (HR), respiratory rate (RR), blood oxygen saturation (SpO₂), mean arterial pressure (MAP) and postoperative C-reactive protein and blood amylase levels were observed and compared between the two groups of patients before the procedure (T0), at the time of entry (T1), at the time of the opening of the endoscope into the duodenal papilla (T2), at the time of exit (T3). Additionally, incidence of adverse events, patient and endoscopist satisfaction were compared between the two groups.

Results  A total of 60 patients were included, 30 in each group. The difference in the trends of VAS and RSS scores over time between the two groups was statistically significant (Ptime×treatment<0.05). Compared to the control group, the experimental group had lower VAS scores and higher RSS scores at T1, T2 and T3 (P<0.05). The differences in SpO₂ and MAP changes over time between the two groups were statistically significant (Ptime×treatment<0.05), with higher values observed in the experimental group at T1-T3 (P<0.05). The incidence of pain, coughing and agitation in the experimental group was lower during the procedure (P<0.05). Both endoscopist and patient satisfaction were significantly higher in the experimental group (P<0.05).

Conclusion  Compared with pethidine combined with diazepam, oxcyodone combined with midazolam as a preoperative medication for awake sedation in ERCP treatment is more effective and safer.

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