Patient-controlled Intravenous Analgesia With Combination of Dexmedetomidine and Sufentanil on Patients After Abdominal Operation: A Prospective, Randomized, Controlled, Blinded, Multicenter Clinical Study.

OBJECTIVE: To investigate the effect of combination of dexmedetomidine and sufentanil on patient-controlled intravenous analgesia (PCIA) in patients after abdominal operation and to assess the safety and validity of this treatment.

METHODS: This is a prospective, randomized controlled, blinded, multicenter clinical study. A total of 210 patients from 9 clinical research centers underwent selective abdominal operation with general anesthesia were enrolled in the study, including laparoscopic-assisted abdominal operation on stomach, intestines or open surgery on stomach, intestines, kidneys and liver, the American Society of Anesthesiologists status I to II. Patients were randomly assigned into 2 groups: control group (group C) sufentanil 100 μg+normal saline 100 mL in total and test group (group D) sufentanil 100 μg+ dexmedetomidine 200 μg+normal saline 100 mL in total. PCIA was set as follow: background infusion of sufentanil 2 μg/h, bolus dose of sufentanil 2 μg, lockout interval 5 minutes. Main measure indices were analgesic consumption, pressing times and effective pressing times of analgesic pump, usage count, and consumption of remedy drug. Validity indices were visual analog scale (VAS) scores and patient satisfaction. Drug safety indices were hemodynamic parameters, drug side effects, and anal exhaust time.

RESULTS: In total, 203 cases were analyzed. Seven cases were eliminated for incomplete data record. The total consumption of sufentanil (μg) in 24 hours after operation of group C and group D were 56.9±21.5 and 49.8±15.5, respectively, and the difference was statistically significant (P<0.05). Pressing times of analgesic pump in 24 hours after operation of group C and group D were 9.47±16.07 and 5.02±5.56 times, respectively, and the difference was statistically significant (P<0.05). Effective pressing times of analgesic pump in 24 hours after operation of group C and group D were 7.8±9.7 and 4.57±5.02 times, respectively, and the difference was statistically significant (P<0.05). Resting VAS scores and movement VAS scores at 2, 4, 8, and 24 hours postoperatively were statistically different (P<0.05). Usage times of rescue drug (pethidine) of group C and group D were 9 and 1, mean rank 118.13 and 85.71, respectively, and the difference was statistically significant (P<0.05). Mean rank of general satisfaction of group C and group D were 98.99 and 105.04, respectively, and the difference was statistically significant (P<0.05). Incidence rate of nausea in group C and group D within 24 hours after surgery was 25% and 12.5%, and of vomiting 18.2% and 6.25%, respectively and of vomiting and the difference was statistically significant.

CONCLUSIONS: Compared with sufentanil PCIA alone, the combination of dexmedetomidine and sufentanil for PCIA after abdominal operation could reduce sufentanil consumption, decrease VAS scores, lower the rate of nausea and vomiting, and improve patient satisfaction.