[A multicenter randomized controlled trial of sufentanil for analgesia/sedation in patients in intensive care unit].

OBJECTIVE

To evaluate the sedation and analgesia power and security of sufentanil in intensive care unit (ICU), and to compare the effect with fentanyl.

METHODS

A multicenter randomized controlled trial was conducted. Critical adult patients in ICU from 11 hospitals in Henan Province from June 2011 to January 2012 who needed analgesia based sedation were enrolled. These patients were randomly divided into two groups with 300 cases in each group using the envelope method according to the hospital number and time sequence number of inclusion. Exclusion criteria included the time of analgesia duration < 48 hours and who were under continuous renal replacement therapy (CRRT) treatment during analgesia. 544 cases were enrolled finally, and there were 282 cases in sufentanil group and 262 in fentanyl group. Before using the drug, there was no statistically significant difference in age, body weight, acute physiology and chronic health evaluation II (APACHEII) score, Glasgow coma scale (GCS) between sufentanil group and fentanyl group, and were comparable. The goal of analgesia was faces pain scale (FPS)≤2. If the dosage of sufentanil and fentanyl exceeded the upper limited dose (sufentanil 0.3 μg×kg(-1)×h(-1), fentanyl 2 μg×kg(-1)×h(-1)) but FPS could not meet (still>2), and maintained the upper limited doses of sufentanil and fentanyl and added midazolam, and FPS≤2 or Ramsay 3 could meet the standard. The analgesia duration of all cases was 48-168 hours. Related data were collected for statistical analysis.

RESULTS

(1) Compared with the data before the analgesia, the mean arterial pressure (MAP) of sufentanil analgesia after analgesia at different time points were significantly decreased (F=6.061, P<0.001) and closed to the normal level, FPS at different time point score were decreased significantly after analgesia (F=259.389, P<0.001), and the changes in pulse oxygen saturation (SpO(2)), respiratory rate and pulse were not found. (2) Compared with before the analgesia, the white blood cell count (WBC), neutrophil percentage (N), platelet count (PLT), aspartate transaminase (AST), creatinine (Cr), arterial partial pressure of carbon dioxide (PaCO(2)), blood lactic acid, blood sugar, C-reactive protein (CRP) were markedly reduced after sufentanil analgesia (WBC: 10.8 ± 4.2 ×10(9)/L vs. 14.2 ± 11.5×10(9)/L, F=49.879, P<0.001; N: 0.806 ± 0.104 vs. 0.815 ± 0.128, F=5.768, P=0.017; PLT: 160.4 ± 77.0 ×10(9)/L vs. 166.1 ± 89.0×10(9)/L, F=6.568, P=0.011; AST: 61.3 ± 10.1 U/L vs. 90.9 ± 26.9 U/L, F=6.706, P=0.010; Cr: 86.7 ± 71.8 μmol/L vs. 119.6 ± 56.0 μmol/L, F=30.303, P<0.001; PaCO(2): 39.4 ± 7.2 mmHg vs. 41.7 ± 22.6 mmHg, F=4.389, P=0.037; blood lactic acid: 1.9 ± 1.2 mmol/L vs. 2.7 ± 2.5 mmol/L, F=4.883, P=0.028; blood sugar: 8.0 ± 5.4 mmol/L vs. 9.7 ± 7.6 mmol/L, F=9.724, P=0.002; CRP: 64.8 ± 20.7 mg/L vs. 114.0 ± 55.9 mg/L, F=4.883, P=0.028). But there were no statistically significant differences in red blood cell count (RBC), prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FIB), thrombin time (TT), alanine aminotransferase (ALT), total bilirubin (TBil), albumin (ALB), total protein (TP) blood urea nitrogen (BUN), and arterial partial pressure of oxygen (PaO(2)) before and after sufentanil analgesia (all P>0.05). (3)There was no statistically significant difference in effectiveness of sufentanil and five times dose of fentanyl (P>0.05). There was no statistically significant difference in the proportion of sedative drugs midazolam usage [18.4% (52/282) vs. 24.8% (65/262), χ(2)=1.151, P=0.283] and the rate of analgesia success [44.3% (125/282) vs. 48.9% (128/262), χ(2)=0.571, P=0.450] and analgesia success [16.3% (46/282) vs. 15.3% (40/262), χ(2)=0.066, P=0.798] between sufentanil and fentanyl group. (4) Comparison of adverse reactions: the incidence of hypotension in sufentanil group was significantly lower than that in fentanyl group [3.2% (9/282) vs. 6.9% (18/262), χ(2)=3.900, P=0.048], and other common adverse reactions, such as respiratory depression/pause, nausea/vomiting and dizziness, pruritus, allergy, slow heart beat (bradycardia) and metabolic reactions had no statistically significant difference. Addiction or tetanus of skeletal muscles was not found in both groups.

CONCLUSIONS

Compared with fentanyl, the analgesia efficacy of sufentanil is stronger. Sufentanil has less physiological interference and lower incidence of adverse reactions for ICU patients.