Comparison of Propofol-nalbuphine and Propofol-fentanyl Sedation for Patients Undergoing Endoscopic Retrograde Cholangiopancreatography

A Double-blind, Randomized Controlled Trial

Peiqi Wang; Yan Chen; Ying Guo; Jiangbei Cao; Hong Wang; Weidong Mi; Longhe Xu


BMC Anesthesiol. 2022;22(47) 

In This Article


Our findings show that propofol-nalbuphine sedation for ERCP significantly decreased the incidence of respiratory depression and surgical interruption compared to that with propofol-fentanyl sedation. Moreover, we observed no differences in the analgesic efficacy and haemodynamic features between the two groups.

ERCP is a complex process that requires deep sedation to be completed successfully.[21,22] However, adverse events, especially respiratory depression, often occur in prone positions during deep sedation.[23,24] Candan Hayturalet al. showed that propofol combined with opioids provides more effective and reliable sedation for ERCP; however, it can still cause respiratory depression and even hypoxia.[10–12] These results are consistent with ours, in which the incidence of respiratory depression was 12.06% in the PF group, and 14 patients developed hypoxia. Even worse, 5 patients developed severe hypoxia, among whom 2 patients had endotracheal intubation. Therefore, the operation had to be interrupted to correct hypoxia. This event may have reduced the satisfaction of the anaesthesiologist and endoscopist, although the patients were unaware of what had happened. However, such conditions were significantly improved in the PN group, and none of the patients underwent endotracheal intubation. Sedation in the PN group greatly lowered the risks of airway management and enhanced the patient safety during the procedure.

The low incidence of respiratory depression in the PN group may be related to the pharmacological properties of nalbuphine.[25] Nalbuphine hydrochloride produces less respiratory inhibition than opioids at the same analgesic dose. It also has a ceiling effect so that respiratory depression does not increase with the dose when it is greater than 30 mg.[25–28] B. Lefevreet al suggested that nalbuphine should be considered a suitable alternative to fentanyl for use in patients undergoing oral surgery because of less respiratory depression.[17] Furthermore, Chaoyi Deng et al. showed that nalbuphine may be a reasonable alternative to sufentanil in patients undergoing colonoscopy.[29] In addition, while nalbuphine can effectively antagonize opioid-induced respiratory depression without adverse endocrine and circulatory changes, nalbuphine still retains its analgesic property.[30] In our study, respiratory depression was not associated with age. Patients in both age groups(18–64 y and > 65 y) had more respiratory depression in the PF group than in the PN group. This suggests that there may be no association of age and reduced incidence of respiratory depression with nalbuphine use, which will need further research.

When respiratory depression occurs during ERCP, it may cause hypoxia, which can mostly be treated with the jaw-thrust manoeuvre.[29,31] This phenomenon was particularly evident in the PN group. Compared to that in the PN group, the hypoxia in the PF group was more severe, as half of the patients were treated with more than one single method (jaw-thrust manoeuvre) to correct the hypoxia. This interrupted the operation, reduced the satisfaction ofthe endoscopists and anaesthesiologists, and increased the difficulties of anaesthesiologists' work. Therefore, nalbuphine had more advantages over fentanyl in reducing hypoxia in ERCP. However, general anaesthesia with endotracheal intubation became necessary when patients were at high risk for sedation-related adverse events. Compared to propofol-based monitored anaesthesia care, nalbuphine use did not impact the duration of the operation, the outcome of the procedure or patient recovery.[32]

Our results are consistent with the findings of others that patients prefer to undergo the ERCP procedure under deep sedation and appropriate analgesia.[21,24] Nalbuphine is a potentanalgesic agent that is similar to morphine.[27,28] Studies have shown that nalbuphineis widely used in pain management during the perioperative period.[29,33–35] Our results showed that nalbuphine was as effective as fentanyl in reducing pain-induced patient movement, and there was no difference in dosage. Patients in both groups had stable haemodynamics during the operation, which suggested that nalbuphine was effective in relieving painful stimuli and reducing adverse events upon completion of the procedure.

We also compared adverse events, such as nausea, vomiting, pruritus, and pain, after surgery between the two groups. Both groups had a slightly higher incidence of adverse reactions(e.g., nausea and fever)compared to groups receiving analgesic drugs in other studies,[36,37] likely due to procedure (ERCP)-related responses.[1] The incidence of vomiting was similar to that in other studies.[36,37] One patient in each group had brief polypnea and dyspnoea after the operation, and both cases improved by nasal oxygen supplementation. Although the reason is still unclear, it may be related to patient anxiety or delayed response of respiratory depression to analgesic drugs.[37] Some patients had abdominal pain one day after surgery, but none had severe pain. Few patients received medical treatment for adverse events, and all patients were discharged from the hospital approximately 7 days after the operation. There was no difference in the length of hospitalization between the two groups. Moreover, other researchers have shown that nalbuphine can be used to treat opioid-induced urinary retention and pruritus,[38,39] which makes it an option to be used together with opioids for procedures such as ERCP.

Our study also has some limitations. This is a single-centre trial with a relatively small patient number. A larger-scale study with more patients in multiple centres is needed in the future.