A prospective, randomized, double-blind, and multicenter trial of prophylactic effects of ramosetron on postoperative nausea and vomiting (PONV) after craniotomy: comparison with ondansetron

Abstract

BackgroundCraniotomy patients have a high incidence of postoperative nausea and vomiting (PONV). This prospective, randomized, double-blind, multi-center study was performed to evaluate the efficacy of prophylactic ramosetron in preventing PONV compared with ondansetron after elective craniotomy in adult patients.MethodsA total of 160 American Society of Anesthesiologists physical status I–II patients aged 19–65 years who were scheduled to undergo elective craniotomy for various intracranial lesions were enrolled in this study. All patients received total intravenous anesthesia (TIVA) with propofol and remifentanil. Patients were randomly allocated into three groups to receive ondansetron (4 mg; group A, n = 55), ondansetron (8 mg; group B, n = 54), or ramosetron (0.3 mg; group C, n = 51) intravenously at the time of dural closure. The incidence of PONV, the need for rescue antiemetics, pain score, patient-controlled analgesia (PCA) consumption, and adverse events were recorded 48 h postoperatively.ResultsAmong the initial 160 patients, 127 completed the study and were included in the final analysis. The incidences of PONV were lower (nausea, 14% vs. 59% and 41%, respectively; P < 0.001; vomiting, P = 0.048) and the incidence of complete response was higher (83% vs. 37% and 59%, respectively; P < 0.001) in group C than in groups A and B at 48 h postoperatively. There were no significant differences in the incidence of PONV or need for rescue antiemetics 0–2 h postoperatively, but significant differences were observed in the incidence of PONV and complete response among the three groups 2–48 h postoperatively. No statistically significant intergroup differences were observed in postoperative pain, PCA consumption, or adverse events.ConclusionIntravenous administration of ramosetron at 0.3 mg reduced the incidence of PONV and rescue antiemetic requirement in craniotomy patients. Ramosetron at 0.3 mg was more effective than ondansetron at 4 or 8 mg for preventing PONV in adult craniotomy patients.Trial registrationClinical Research Information Service (CRiS) Identifier: KCT0000320. Registered 9 January 2012.

The Effect of a Transdermal Scopolamine Patch on Postoperative Nausea and Vomiting after Retromastoid Craniectomy with Microvascular Decompression: A Preliminary Single Center, Double-Blind, Randomized Controlled Trial

“…Despite great advances in modern neurosurgical techniques and anesthesia, PONV remains one of the most common postoperative concerns and challenges for subjects and clinicians after craniotomy. Its incidence has been reported to be high as 73% after craniotomy, and it usually leads to patient discomfort, delayed discharge from the hospital, and increased medical costs [2,3]. In addition, PONV may result in an increased risk of aspiration, intracranial hypertension, and neurological deterioration in neurosurgical patients [4].…”

Population pharmacokinetics and prophylactic anti‐emetic efficacy of ramosetron in surgical patients

“…bolus administration of 0.3 mg ramosetron showed better anti-emetic efficacy than that of 4 mg i.v. ondansetron in earlier studies [13,14]. This may be due to the additional ondansetron that was mixed in the i.v.…”

“…In earlier studies that compared the prophylactic efficacies of ramosetron and ondansetron, 0.3 mg ramosetron demonstrated better efficacy for reducing PONV and increased the complete response rate compared with 4 mg ondansetron . However, those studies included small to moderate sample sizes and only a single type of surgery , and comparative studies in low risk groups have not been performed . Anti‐emetic efficacy could be exaggerated if the drug is evaluated selectively in a population with a high incidence of PONV, because PONV occurs more frequently in populations with higher Apfel scores .…”

“…In earlier studies that compared the prophylactic efficacies of ramosetron and ondansetron, 0.3 mg ramosetron demonstrated better efficacy for reducing PONV and increased the complete response rate compared with 4 mg ondansetron [8][9][10][11][12][13][14]. However, those studies included small to moderate sample sizes and only a single type of surgery [8][9][10][11][12][13][14], and comparative studies in low risk groups have not been performed [9][10][11][12].…”

Preoperative headache in patients submitted to unrupted brain aneurysm clamping

“…Nausea and vomiting were symptoms referred by patients with pain. Prophylactic administration of antiemetics may decrease and/or prevent nausea and vomiting in patients submitted to craniotomy 15 . Adequate prevention and treatment of nausea and vomiting minimizes possible postoperative troubles such as bronchial aspiration, hydroelectrolyte imbalance and increased intracranial pressure.…”