Abstract
Postoperative nausea and vomiting (PONV) is among the most common distressing complications of surgery under anesthesia. Previous studies have demonstrated that patients who undergo craniotomy have incidences of nausea and vomiting as high as 50-70%. The main purpose of this pilot study is to assess the incidence of PONV by using two different prophylactic regimens in subjects undergoing a craniotomy. Thus, we designed this study to assess the efficacy and safety of triple therapy with the combination of dexamethasone, promethazine, and aprepitant versus ondansetron to reduce the incidence of PONV in patients undergoing craniotomy. This is a prospective, single center, two-armed, randomized, double-dummy, double-blind, pilot study. Subjects were randomly assigned to one of the two treatment groups. Subjects received 40 mg of aprepitant pill (or matching placebo pill) 30-60 min before induction of anesthesia and 4 mg of ondansetron IV (or 2 ml of placebo saline solution) at induction of anesthesia. In addition, all subjects received 25 mg of promethazine IV and 10 mg of dexamethasone IV at induction of anesthesia. Assessments of PONV commenced for the first 24 h after surgery and were subsequently assessed for up to 5 days. The overall incidence of PONV during the first 24 h after surgery was 31.0% (n = 15) in the aprepitant group and 36.2% (n = 17) for the ondansetron group. The median times to first emetic and significant nausea episodes were 7.6 (2.9, 48.7) and 14.3 (4.4, 30.7) hours, respectively, for the aprepitant group and 6.0 (2.2, 29.5) and 9.6 (0.7, 35.2) hours, respectively, for the ondansetron group. There were no statistically significant differences between these groups. No adverse events directly related to study medications were found. This pilot study showed similar effectiveness when comparing the two PONV prophylaxis regimens. Our data showed that both treatments could be effective regimens to prevent PONV in patients undergoing craniotomy under general anesthesia. Future trials testing new PONV prophylaxis regimens in this surgical population should be performed to gain a better understanding of how to best provide prophylactic treatment.
Highlights
Nausea and vomiting are known to be among the most common distressing postsurgical complications
This study explored the effects of triple therapy to prevent postoperative nausea and vomiting (PONV) as a primary endpoint, which is defined as nausea and/or vomiting during the first 24 h after a surgical procedure
Tsutsumi et al designed a similar randomized study that evaluated the effects of IV fosaprepitant versus IV ondansetron on the prevention of PONV in neurosurgery patients (24)
Summary
Nausea and vomiting are known to be among the most common distressing postsurgical complications. Both of these conditions are associated with prolonged post-anesthesia care, delayed patient recovery and discharge, and increased overall cost of surgical intervention (1–7). Postoperative nausea and vomiting treatment and prevention may prove imperative to the postsurgical outcomes of patients undergoing craniotomies. Retching and vomiting increases intracranial and intravascular pressure, leading to homeostatic changes and a decrease in cerebral perfusion (7). These factors are important to consider in neurosurgical settings as they can increase the risk for brain swelling and surgical debridement following craniotomy (7). Sedated patients are at higher risk of aspiration from vomiting due to the impairment of their airway reflexes; the use of antiemetic medications with few sedative properties are recommended as the preferred course of treatment (1, 8, 9)
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