Abstract
Patients undergoing laparoscopic gynecologic surgery and receiving postoperative analgesia with opioids have a high risk of postoperative nausea and vomiting (PONV). We compared the antiemetic efficacy of three doses of ramosetron in this high-risk population. In this prospective, double-blind trial, 174 patients randomly received ramosetron 0.3 mg (R0.3 group; n = 58), 0.45 mg (R0.45 group; n = 58), or 0.6 mg (R0.6 group; n = 58) at the end of surgery. The primary outcome was the incidence of PONV during the first postoperative 48 h. Nausea severity, pain scores, adverse events, and patient satisfaction (1–4; 4, excellent) were assessed. The incidence of PONV was not different between groups (35%, 38%, and 35% in R0.3, R0.45, and R0.6 groups; p = 0.905). Nausea severity, pain scores, and incidence of adverse events (dizziness, headache, or sedation) were similar between groups. Compared to the R0.3 group, the R0.45 and R0.6 groups had lower incidence of premature discontinuation of fentanyl-based patient-controlled analgesia primarily because of intractable PONV (9% and 5% vs. 24%; p = 0.038), and higher satisfaction scores (3.4 ± 0.8 and 3.3 ± 0.7 vs. 2.4 ± 0.9; p = 0.005). Compared to ramosetron 0.3 mg, ramosetron 0.45 and 0.6 mg did not reduce PONV, but reduced premature discontinuation of patient-controlled analgesia and increased patient satisfaction, without increasing adverse events.
Highlights
Postoperative nausea and vomiting (PONV) is a distressing and common complication of general anesthesia and surgery
Patients undergoing laparoscopic gynecologic surgery and receiving opioid-based patient-controlled analgesia (PCA) after surgery may be at high risk of PONV because of patient and surgical factors [1,2]
We estimated that a total of 159 patients would be required to detect a 30% reduction in PONV from a basal incidence of 70%, with 90% power at a significance of p < 0.05
Summary
Postoperative nausea and vomiting (PONV) is a distressing and common complication of general anesthesia and surgery. Patients undergoing laparoscopic gynecologic surgery and receiving opioid-based patient-controlled analgesia (PCA) after surgery may be at high risk of PONV because of patient and surgical factors [1,2]. The incidence of PONV may be as high as 80% in high-risk patients [3]. Numerous strategies involving the use of different pharmacological classes (including anticholinergics, antihistamines, phenothiazines, and butyrophenones) have been employed to prevent PONV [4], no approach is universally successful. 5-hydroxytryptamine (5-HT3) receptor antagonists are recommended as first- and second-line pharmacologic antiemetic agents for PONV prophylaxis because of their efficacy and limited side effects [5]. Ramosetron is the most recently developed selective 5-HT3 receptor antagonist, and is more effective than other 5-HT3 receptor antagonists because of its higher receptor binding capacity and longer half-life [6]
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