Baylor University Medical Center Proceedings January 2014, Volume 27, Number 1 | Page 9

Table 2. Results for subjects randomized to placebo compared to intravenous dexmedetomidine Placebo group (n = 19) Variable Dexmedetomidine group (n = 19) P value a. Demographic characteristics Age (years) 56 ± 13 Male 61 ± 11 0.24 7 (37%) 8 (42%) Female 12 (63%) 11 (58%) Weight (kg) 79.4 ± 20.4 79.2 ± 14.8 Body mass index 25.8 ± 5.4 25.3 ± 4.8 African American 0 1 (5%) Asian 0 1 (5%) 19 (100%) 17 (89%) Total infusion time (minutes) 1281 ± 288 1214 ± 347 0.52 Total study drug administered (mcg) 496† ± 239 497 ± 268 0.50 541 ± 257 576 ± 282 0.35 Caucasian 1.0 0.97 0.35 b. Drug administration Total study drug administered (mcg) adjusted to 24 hours 0.60 Early withdrawal Consent withdrawn Hypotension Pneumonia Volume depletion — — — 1 (5%) 1 (5%) 1 (5%) 1 (5%) — IV morphine equivalency administered (mg) 49 ± 35 29 ± 26 0.03* IV morphine equivalency administered (mg) adjusted for total time on study drug 54 ± 37 35 ± 28 0.04* c. Type of opioid use PCA Morphine sulfate: 18 Hydromorphone: 1 Morphine sulfate: 17 Hydromorphone: 2 Supplemental opioids Hydrocodone: 3 Meperidine (IV): 1 Hydrocodone/fentanyl (IV): 1 Hydrocodone: 4 Hydromorphone: 1 Fentanyl (transdermal): 1 d. Vital signs Systolic blood pressure (mm Hg) 125 ± 11.4 114 ± 11.1 Diastolic blood pressure (mm Hg) 65 ± 7.4 64 ± 5.3 0.008* 0.41 Heart rate (beats per minute) 90 ± 12.3 80 ± 12.3 0.01* Respiratory rate (breaths per minute) 20 ± 2.8 19 ± 2.3 0.41 drug was resumed only with a systolic blood pressure of >89 mm Hg and after a minimum of 30 minutes and no longer than 4 hours had passed. Three of the five subjects, one in the placebo group and two in the dexmedetomidine group, did not require any interventions, and the study drug was resumed with no further complications. One dexmedetomidine subject experienced mild hypotension and had the study drug interrupted and restarted 30 minutes later with no interventions. Five and a half hours later, this same subject experienced hypotension and the study drug was interrupted. The study drug remained off and the subject was withdrawn from the study due to pneumonia and the sepsis syndrome that had developed. This same subject also was the one dexmedetomidine subject to experience tachycardia. A second dexmedetomidine subject had the study drug interrupted due to hypotension, which required treatment of a 250 mL normal saline bolus. The study drug was resumed 95 minutes later. This subject was withdrawn from the study 70 minutes after the second start of the study drug when it was discovered that a concurrent betablocker had been administered and the subject experienced a second episode of hypotension. Adverse events associated with opioid administration such as constipation, nausea, and pruritus were reported in greater numbers in the placebo group (placebo = 12 vs dexmedetomidine = 4). The odds ratio of developing one of these side effects in the dexmedetomidine group was 0.3 compared with the placebo group, with a 95% confidence interval of (0.07, 1.23). Pulse oximetry (%) 98 ± 1.6 97 ± 1.7 0.13 Transcutaneous carbon dioxide (mm Hg) 44 ± 5.3 43 ± 6.7 0.58 Pain score 3 ± 1.7 3 ± 2.3 0.52 Ramsay Sedation Scale 2 ± 0.1 2 ± 0.1 0.01* *P < 0.05. †Calculated based on infusion rates assuming concentration of dexmedetomidine group. Data are presented as mean ± standard deviation or n (%). January 2014 DISCUSSION The standard procedure for managing postoperative pain for thoracotomy patients in this institution is to provide a paraverteb Ʌ