Propofol and remifentanil patient controlled sedation/analgesia versus remifentanil infusion during interventional radiological procedures.

The study was conducted with the approval of Faculty Ethics Committee (Ref. no. 2009/357). This study included 60 patients between 18 and 70 years of age who had ASA I–III and were undergoing interventional radiology procedures for diagnostic and treatment purposes. Informed consent was obtained from all individual participants included in the study. Patients who had allergic reaction to medications to be used, patients with serious cardiovascular and respiratory system diseases, obesity, sleep apnea syndrome, high risk of pulmonary aspiration, or pregnancy, patients who were unable to grasp the meaning of PCAS, and unaccompanied patients were excluded from the study. Patients who were scheduled to undergo painful interventional radiological procedures under local anesthesia were randomly assigned into either the remifentanil (Ultiva; GlaxoSmithKline, Italy) infusion group (Group R; (n) 30 patient) or the remifentanil–propofol (Propofol; Fresenius Kabi, Sweden) PCAS group (Group PR; (n) 30 patient) according to a computer-generated randomization list. Premedication was not performed in any of the cases. An ante-cubital vein was cannulated for intravenous infusions and drug administration. In group R, remifentanil was diluted in 0.9% physiological saline (concentration of 40 µg.mL-1) and administered at 0.2 µg/kg bolus dose, followed by a 0.05 µg/kg/min infusion. Meanwhile, in group PR, a mixture of 10 µg.mL-1 remifentanil and 10 mg.mL-1 propofol was administered via a PCAS device. In the PCAS device the initial loading dose was set at 2.5 mL (25 mg propofol – 25 µg remifentanil) and the bolus dose was set at 1 mL (10 mg propofol–10 µg remifentanil). The lockout time was not set. The patients from group PR were instructed about using the PCAS (Abbott Pain Manager; Abbott Laboratories, Chicago, IL, USA) device during the preanesthetic evaluation. Baseline hemodynamic values were recorded before the procedure. Electrocardiogram (ECG), peripheral oxygen saturation (SpO2), noninvasive arterial pressure, respiratory rate (RR), Visual Analog Scale (VAS) (0; no pain; 10; severe pain), and Ramsey sedation score (RSS) (1;anxious and agitated; 2;cooperative; 3;responding to verbal commands; 4;responding to minor stimulation; 5;responding to deep stimulation; and 6;no response to stimulation) values were recorded every 5 minutes during the procedure. The presence of anxiety in patients was noted as “yes” or “no.” All patients were informed about VAS prior to the procedure. VAS scores were assessed as follows: 1–3, mild pain; 4–7, moderate pain; and score greater than 7, severe pain. A sufficient sedation level for this study was determined as 2–3 according to RSS. Patients were asked to indicate the severity of pain during the procedure. The patients were given 2 L/min oxygen via a face mask then the radiologist administered local anesthetics (2% prilocaine at 3 mg/kg dose) to all patients subcutaneously in addition to intravenous sedation and analgesia. When VAS scores were 4, 10 µg remifentanil as an intravenous bolus dose in group R and 10 µg remifentanil–10 mg propofol from PCAS devices in group PR were administered. In both the groups, patients whose RSS was 1 received 1 mg dose of midazolam (Dormicum, Roche, Germany) for additional sedation. Naloxone hydrochloride and flumazenil were available during all the procedures. An experienced radiologist carried out all of the procedures. During the procedure and in the recovery room, heart rate (HR), mean arterial pressure (MAP) and SpO2 was recorded at 5-minute intervals after getting basal values. Hypotension, bradycardia, desaturation, apnea, nausea, vomiting, euphoria, and shivering were recorded as intraoperative and postoperative complications. If the saturation decreased below 90%, oxygen given via the face mask was increased at a rate of 4 L/min in both the groups, the infusion was stopped in group R, and 1 minute lockout time was set in group PR. The patient was awakened with tactile stimulation or with a loud noise. The head was positioned accordingly. A plan to treat the patients who developed bradycardia with 0.5 mg atropine was prepared. Meanwhile, the patients who developed hypotension and did not respond to the increased fluid infusion were planned to be treated with 5–10 mg ephedrine. Moreover, metoclopramide, which is an antiemetic drug, was planned for the treatment of nausea and vomiting. Drug infusion was continued until the end of the procedure. After the procedure, the patients were taken to the recovery room, and after a 5-minute break, their noninvasive arterial pressure, HR, SpO2, and modified Aldrete score (MAS) (6) were measured and recorded. The patient vital signs were measured at 5-minute intervals while patients were awake (MAS; 10) for at least 30 minutes in the recovery room. Prior to discharge, the patients were asked to grade their satisfaction of the applied anesthesia technique by using a 6-point satisfaction scale (0;very poor; 1;poor; 2;moderate; 3;good; 4;very good; 5;excellent). At the end of the process the same scale was used to assess the satisfaction of the radiologists. Then, the patients were discharged with a companion. The Student's t test was used to compare the differences between the groups for the parametric data. The chi-square test was used for nonparametric data. The two-way analysis of variance test was used to assess the change based on time. P small 0.05 was considered statistically significant.