Prevention of Nausea and Vomiting in Patients After Surgery
Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
Summary
Postoperative nausea and vomiting (PONV) is a common problem after general anesthesia. The
incidence can be as high as 80 percent in high-risk patients. Investigators designed this
randomized, double- blind, single-center study to compare the efficacy of the combination of
dexamethasone with ondansetron and dexamethasone with aprepitant undergoing laparoscopic
surgery.
Seventy American Society of Anesthesiologist (ASA) physical class I-II, age 18-60 years
patients scheduled for laparoscopic surgery were included in this study. Anesthesia was
induced with propofol, fentanyl, and rocuronium, and maintained with sevoflurane in oxygen /
air mixture in all patients. Remifentanil was continuously infused during surgery. Patients
were randomly divided into two groups. Patients in the dexamethasone and aprepitant group
(group DA, n=35) received 40 mg aprepitant orally 1 to 2 hours before induction of anesthesia
and 2 ml saline intravenous (iv) within the last 30 minutes of surgery. Patients in the
dexamethasone and ondansetron group (group DO, n=35) received an oral placebo identical to
aprepitant 1 to 2 hours before induction of anesthesia and 4 mg ondansetron iv within the
last 30 minutes of surgery. All patient received iv 8 mg dexamethasone after induction of
anesthesia.
PONV and postoperative opioid consumption were assessed for 24 hours postoperatively. The
blindly evaluated primary outcome was complete response. The secondary outcomes were
incidence of nausea, retching or vomiting, the need of rescue antiemetic and opioid
consumption within 24 hours after surgery. Statistical analyses were performed using
Mann-Whitney U test, Chi-square test, and Fisher's Exact test. P<0.05 was considered
statistically significant.Investigators hypothesized that the antiemetic efficacy of the
aprepitant and dexamethasone combination is superior compared with ondansetron and
dexamethasone combination following the laparoscopic surgery.