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

Disclosures

BMC Anesthesiol. 2022;22(47) 

In This Article

Results

This study recruited 400 patients scheduled for ERCP from May 2018 to June 2019 at our centre. The patients were randomized to two groups. The PN group included 201 patients, and the PF group had 199 patients. The patients' characteristics (age, sex, BMI, ASA classification, and Mallampati scores) and procedure details (surgical time and types of the procedure) are compared in Table 1 (p > 0.05). Most of the procedures were performed within one hour. Choledocholithiasis was the most common indication for ERCP.

There were no significant differences in the haemodynamic features of the patients (HR, MAP, RR, and SpO2) between the two groups (p > 0.05), although the PF group showed greater fluctuation than the PN group did in HR, MAP and SpO2.

Respiratory depression was the primary outcome, and surgical interruptions were the secondary outcome in the study. Adverse events such as respiratory depression and interruptions during the procedure are listed in Table 2. The PN group had a significant decrease in the total percentage of respiratory depression compared with that in the PF group (p < 0.0001,95% CI:1.04–3.93). Fourteen (14/199,7.04%, p = 0.03,95% CI: 0.86–1.88) patients had hypoxia, and 5 (5/199,2.51%, p = 0.048,95% CI: 1.17–2.45) patients developed severe hypoxia in the PF group, while there were only 6 (6/201,2.99%) patients with hypoxia and 1(1/201,0.50%) patient with severe hypoxia in the PN group. Respiratory depression was not associated with age, as patients aged 18–64 yr (p < 0.0001,95% CI: 1.04–1.94) and 65–79 yr (p < 0.0001,95% CI: 0.87–2.07) had more respiratory depression in the PF group than in the PN group.

In the PN group, 12(12/201, 5.97%) patients received a combined method of correcting respiratory depression, which was significantly lower (p < 0.0001,95% CI: 1.04–3.93) than that in the PF group (24/199, 12.06%). There were 8 patients who needed assisted ventilation with jaw thrusts in the PN group and 12 such patients in the PF group. One patient in the PN group require da jaw thrust and a nasopharyngeal airway versus 4 patients in the PF group. There were 3 patients in the PN group and 6 patients in the PF group who were turned to the supine position and received assisted ventilation with two methods. Two patients needed tracheal intubation for mechanical ventilation in the PF group, while no patient had tracheal intubation in the PN group. There were no differences in the rescue methods between the two groups.

In the PF group, 45 (45/199, 22.61%) cases were interrupted during the procedure by patient movement or desaturation (2 patients underwent tracheal intubation), while 30, 30/201, 14.93%) cases were interrupted in the PN group (p = 0.02,95% CI: 1.02–1.57). There were no differences in the score of patient movement between the two groups.

The total doses of drugs, including midazolam, propofol, fentanyl, nalbuphine, ephedrine, and atropine, are shown in Table 3(p > 0.05).

The endoscopists rated more cases as (III) not satisfactoryin the PF group (Table 4). Eight patients in the PF group and 11 in the PN group were rated as (II) indeterminate. Additionally, anaesthesiologists rated fewer cases as (III) not satisfactory and (II) indeterminate in the PN group. There were no differences in the satisfaction scores of either endoscopistsor anaesthesiologists between the two groups(p > 0.05). The satisfaction scores of the patients were similar in both groups (p > 0.05). They were discharged approximately seven days after surgery, and no significant differences were observed in hospitalization days between the two groups (p > 0.05).

The incidence of postoperative adverse effects one day after ERCP in the two groups is shown in Table 5. Some patients had nausea, vomiting and abnormal pain in both groups (p > 0.05). A small number of patients had fever, and only one patient had polypnea and dyspnoeaon Day 1 after the operation in both groups ( p > 0.05). The symptoms of 2 patients were improved by nasal oxygen supplementation. None of the patients reported any experience of pruritus, aspiration pneumoniaor cough.

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