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Comparison of Ramosetron and Ondansetron

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Comparison of Ramosetron and Ondansetron Journal name: Therapeutics and Clinical Risk Management Article Designation: Original Research Year: 2018 Volume: 14 Therapeutics and Clinical Risk Management Dovepress Running head verso: Choi et al Running head recto: Ramosetron for established PONV open access to scientific and medical research DOI: 159211 Open Access Full Text Article ORIGINAL RESEARCH Comparison of ramosetron and ondansetron for the treatment of established postoperative nausea and vomiting after laparoscopic surgery: a prospective, randomized, double-blinded multicenter trial Yong Seon Choi1,* Background: Postoperative nausea and vomiting (PONV) is a common complication after Hye-Min Sohn2,* surgery, which increases physical and psychological discomfort and delays recovery. The aim Sang-Hwan Do2 of this study was to test the hypothesis that ramosetron is comparable to ondansetron for the Kyeong Tae Min1 treatment of established PONV after laparoscopic surgery using a prospective, randomized, Jae Hee Woo3 double-blinded, noninferiority study. For personal use only. Hee Jung Baik3 Methods: Patients who had at least two risk factors of PONV and underwent laparoscopic surgery under general anesthesia were assessed for eligibility. Patients who developed PONV 1 Department of Anesthesiology within the first 2 h after anesthesia received ondansetron (4 mg) or ramosetron (0.3 mg) intra- and Pain Medicine, Anesthesia and Pain Research Institute, Severance venously in a randomized double-blind manner. Patients were then observed for 24 h after drug Hospital, Yonsei University College administration. The incidence of nausea and vomiting, severity of nausea, rescue antiemetic of Medicine, Seoul, Republic of Korea; necessity, and adverse effects at 0–2 or 2–24 h after drug administration was evaluated. The 2Department of Anesthesiology and Pain Medicine, Seoul National primary endpoint was the rate of patients exhibiting a complete response, defined as no emesis University Bundang Hospital, and no further rescue antiemetic medication for 24 h after drug administration. Seongnam, Republic of Korea; 3Department of Anesthesiology and Results: Among the 583 patients, 210 (36.0%) developed PONV and were randomized to Pain Medicine, College of Medicine, either the ondansetron (n=105) or ramosetron (n=105) group. Patient’s characteristics were Ewha Womans University, Seoul, similar between the groups. The complete response rate was 44.1% in the ondansetron group Republic of Korea and 52.9% in the ramosetron group after 24 h of initial antiemetic administration. The incidence *These authors contributed equally of adverse events was not different between the groups. to this work Therapeutics and Clinical Risk Management downloaded from https://www.dovepress.com/ by 128.134.207.84 on 26-Jul-2018 Conclusion: We found evidence to support the noninferiority of ramosetron (0.3 mg) compared to ondansetron (4 mg) for the treatment of established PONV in moderate to high-risk patients undergoing laparoscopic surgery. Keywords: laparoscopic surgery, ondansetron, postoperative nausea and vomiting, ramosetron, non-inferiority, antiemetic Introduction Correspondence: Hee Jung Baik Department of Anesthesiology Despite considerable effort in evaluating antiemetic strategies and the development of and Pain Medicine, College of a new antiemetic class, postoperative nausea and vomiting (PONV) remains one of the Medicine, Ewha Womans University, most common and distressing complications after surgery. PONV not only increases 1071 Anyangcheon-ro, Yangcheon-gu, Seoul 07985, Republic of Korea physical and psychological discomfort but also causes wound dehiscence, dehydra- Tel +82 2 2650 2868 tion, and electrolyte imbalance, which leads to delayed recovery, prolonged hospital Fax +82 2 2655 2924 Email [email protected] stays, and life-threatening aspiration.1,2 Published evidence suggests that prophylactic submit your manuscript | www.dovepress.com Therapeutics and Clinical Risk Management 2018:14 601–606 601 Dovepress © 2018 Choi et al. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you http://dx.doi.org/10.2147/TCRM.S159211 hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). Powered by TCPDF (www.tcpdf.org) 1 / 1 Choi et al Dovepress administration of antiemetic drugs should be considered for (serum Cr .1.6 mg/dL) or hepatic (liver enzymes more than patients with two or more PONV risk factors, such as the twice the normal value) insufficiency, conversion to open female gender, nonsmoking, and the use of postoperative laparotomy, pregnant, breastfeeding, borderline QTc prolon- opioids.3,4 In addition, various approaches to prevent or treat gation (.430 ms for male, .450 ms for female), and unable PONV have been studied, especially for high-risk patients, to understand pain scoring or express the PONV degree. which contribute to early recovery, increased patient satisfac- tion, and reduced side effects. Intraoperative and postoperative Among the currently available antiemetics, management 5-hydroxytryptamine receptor 3 (5-HT3) antagonists are The anesthetic techniques were controlled at all three institu- frequently used for prophylaxis against PONV and treat- tions. Premedication was not administered. Anesthesia was ment of established PONV. Ramosetron is a newly devel- induced using propofol (1.5–2 mg/kg) and fentanyl (1 µg/kg) oped selective 5-HT3 receptor antagonist with longer action or remifentanil (0.5–1 µg/kg/min) under standard monitoring; duration (up to 48 h) and higher receptor affinity than its rocuronium (0.6 mg/kg) was administered to facilitate previously developed congeners, including ondansetron.5–7 tracheal intubation. The patient’s lungs were ventilated with Ondansetron is an effective prophylactic and therapeutic a tidal volume of 8 mL/kg of ideal body weight in 50% 8–10 5-HT3 receptor antagonist for the treatment of PONV. oxygen with air. Respiratory rate was adjusted to maintain Although ramosetron is superior to ondansetron for prevent- an end-tidal CO2 pressure of 35–45 mmHg. Anesthesia was ing PONV, ramosetron and ondansetron have never been maintained with sevoflurane or desflurane and remifentanil compared with respect to their therapeutic efficacy in treating (0.1–0.3 µg/kg/min). For management of postoperative pain, a established PONV. single bolus dose of fentanyl (1 µg/kg) was administered intra- Therefore, we designed a randomized controlled trial to venously 15 min before the end of surgery, and remifentanil compare the therapeutic efficacy of ramosetron and ondanse- intravenous infusion was stopped. Fentanyl (15–20 µg/kg at tron for the treatment of established PONV in patients 2 mL/h, 0.5 mL bolus, 15 min lock-out time, total 100 mL) For personal use only. following laparoscopic surgery under general anesthesia. was used in intravenous patient-controlled analgesia (PCA) pumps if indicated to control acute postoperative pain. Methods After extubation and transfer to the postanesthesia care After obtaining approval from the institutional review boards unit (PACU), the patients were monitored with routine care of Yonsei University Severance Hospital, Seoul National and supplementary oxygen through a face mask. During University Bundang Hospital, and Ewha Womans University PACU care, if patients developed nausea with numerical Mokdong Hospital, a total 610 patients undergoing laparo- rating scale (NRS) $4 or vomiting within 2 h postopera- scopic surgery between July 2015 and September 2016 were tively, the therapeutic intervention designed to treat PONV assessed for eligibility. An independent institutional review ensued. The patients were randomly allocated into one of the board from all the institutions at which the participating two groups: the ondansetron group (Zofran® 4 mg) or ramose- anesthesiologists are affiliated has approved this study. This tron group (Nasea® 0.3 mg), using computer-generated ran- study was registered at http://ClinicalTrials.gov (registration dom number codes. When nausea of NRS $4 or vomiting Therapeutics and Clinical Risk Management downloaded from https://www.dovepress.com/ by 128.134.207.84 on 26-Jul-2018 number NCT03017222). still existed, metoclopramide (10 mg) as additional rescue Written informed consent was obtained from all patients antiemetic was administered and recorded. If PONV did before they were recruited. Patient inclusion criteria were not develop within 2 h postoperatively, we excluded the as follows: age 19–65 years, undergoing elective laparo- patient from study enrollment and administered prophylactic scopic surgery under inhalation anesthesia, surgery duration antiemetic agents, given the presence of the relevant risk between 30 min and 4 h, American Society of Anesthe- factors for PONV. The study drugs were prepared in identical siologists physical status I or II, and at least two of these syringes and administered by the personnel who were not risk factors: female gender, history of motion sickness or involved in this study. All patients, physicians, and investiga- PONV, nonsmoking, and
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