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The Effectiveness of Ramosetron and Ondansetron for Preventing

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The Effectiveness of Ramosetron and Ondansetron for Preventing Lee et al. Journal of Orthopaedic Surgery and Research (2020) 15:523 https://doi.org/10.1186/s13018-020-02060-3 RESEARCH ARTICLE Open Access The effectiveness of ramosetron and ondansetron for preventing postoperative nausea and vomiting after arthroscopic rotator cuff repair: a randomized controlled trial Sang-Uk Lee1, Hyo-Jin Lee2 and Yang-Soo Kim2* Abstract Background: Arthroscopic rotator cuff repair is a painful procedure, and treatment of emetic events associated with drugs used in the current multimodal pain management remains challenging. This study aimed to evaluate the effectiveness of ramosetron or ondansetron to relieve postoperative nausea and vomiting (PONV) and pain after arthroscopic rotator cuff repair. Methods: In total, 122 consecutive patients undergoing arthroscopic rotator cuff repair were randomly allocated into three groups: ramosetron group (n = 39), ondansetron group (n = 43), and control group (n = 40). Then, 0.3 mg of ramosetron or 8 mg of ondansetron was administered intravenously at the end of surgery according to group. All patients received general anesthesia and multimodal pain management protocol including preemptive analgesic medication, fentanyl-based intravenous patient-controlled analgesia, and postoperative analgesic medication. Incidence of emetic events, rescue antiemetic requirements (10 mg of metoclopramide, IV), complete response, pain level, and side effects were recorded in three periods: 0–6, 6–24, and 24–48 h postoperatively. The severity of nausea and pain was evaluated using a visual analog scale. Results: The ramosetron group tended to have a lower incidence and severity of nausea during the 6- to 24-h postoperative period and fewer rescue antiemetic drug requirements during the 0- to 48-h period than the control group, showing statistical significance. Additionally, the frequency of complete response of the ramosetron and ondansetron groups was significantly higher than that of the control group. No difference was found among the groups in the pain level except during the 0- to 6-h period. The two groups have a higher complete response during the 6- to 24-h period than the control group. Conclusions: Ramosetron use led to a lower incidence, mild severity of nausea, and reduced use of rescue antiemetic drug after arthroscopic rotator cuff repair during the 6- to 24-h postoperative period than the control. (Continued on next page) * Correspondence: [email protected] 2Department of Orthopedic Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 222, Banpo-daero, Seocho-gu, Seoul, Republic of Korea Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Lee et al. Journal of Orthopaedic Surgery and Research (2020) 15:523 Page 2 of 8 (Continued from previous page) Level of evidence: Level I, randomized controlled trials, treatment study Keywords: PONV (postoperative nausea and vomiting), Rotator cuff tear, Arthroscopic cuff tear repair, Ramosetron, Ondansetron Introduction events and the use of rescue antiemetic drug, and [22] Rotator cuff disease is one of the common causes of ramosetron or ondansetron influences pain levels in pa- shoulder pain and is commonly treated by arthroscopic tients managed with analgesics and fentanyl-based intra- rotator cuff repair, in which patients tend to experience venous PCA after arthroscopic rotator cuff repair. intense postoperative pain [1, 2]. Adequate pain manage- This article fits into the framework of translational ment would not only increase patient satisfaction, but also orthopedic: how to evaluate the efficacy of ramosetron shorten the hospital stay [3, 4]. However, many anesthetic in surgery of arthroscopic rotator [23–25]. and analgesic drugs used in pain control commonly provoke postoperative nausea and vomiting (PONV) after Materials and methods orthopedic surgery, from 20 to 81% [5–8]. Although intra- Patient population venous (IV) opioids have many advantages in the pain This prospective randomized, double-blinded trial study management, PONV causes dehydration, increased pain was approved by the Hospital Institutional Review perception, wound dehiscence, delayed recovery, wors- Board, and informed written consent was obtained from ened patient satisfaction [9, 10], and pulmonary aspiration all reviewed subjects. However, in 2011, when we [11]. Therefore, when patients with high risk of conducted the study, the Clinical Research Information PONV are planned to be treated with opioid-based Service (CRIS) was not implemented in our country. So, IV patient-controlled analgesia (PCA), appropriate we enrolled in CRIS retrospectively for our experiments prophylactic antiemetic treatment should be consid- and then were issued the registration number (KCT0004460 ered, rather than treating the established PONV. on CRIS). The authors confirm that all ongoing and related Several studies report variable responses to specific trials for this drug/intervention are registered. antiemetic drugs [12–14]. Among various antiemetic A total of 122 patients undergoing arthroscopic rotator drugs tried, serotonin receptor antagonists such as cuff repair surgery between September 2011 and February ondansetron [15], granisetron [16], and dolasetron [17] 2013 were randomized to receive either ramosetron (n = are the most commonly used to prevent PONV. How- 39), ondansetron (n = 43), or placebo (n = 40). So, we ever, they have very short duration of action to cover the enrolled and followed up patients from September 1, immediate postoperative period and have limited effect 2011, to February 31, 2013. on postoperative vomiting rather than an anti-nausea ac- The inclusion criterion was ambulatory patients tion [9, 18, 19]. Several studies reported that ramosetron, undergoing arthroscopic rotator cuff repair surgery. The which is a serotonin 5-hydroxytryptamine type 3 (5- exclusion criteria were as follows: (a) previous surgery, HT3) receptor antagonist for PONV treatment, has bet- (b) trauma history, (c) intolerance or allergy to any drugs ter effectiveness and longer-acting properties than other used in the study, (d) severe bowel motility impairment, serotonin receptor antagonists [6, 9, 20]. (e) administration of another antiemetic drug 24 h be- However, information on the effectiveness of ramose- fore surgery, (f) alcohol or opioid dependence, (g) history tron on PONV prevention in orthopedic patients is lim- of cardiovascular or respiratory disease, and (h) renal or ited, and a few clinical studies have compared the hepatic functional impairments. prophylactic efficacies of ondansetron, ramosetron, and In addition, we excluded patients when general anesthesia placebo after arthroscopic rotator cuff repair. Therefore, was contraindicated. After assessing 147 patients for eligi- the aim of this prospective, randomized, double-blinded bility, we excluded 19 patients before enrollment for various trial was to compare the antiemetic effectiveness of reasons; subsequently, 128 patients were enrolled for prophylactic administration of ondansetron, ramosetron, randomization (Fig. 1). Patients were randomly allocated and placebo in high-risk patients with fentanyl-based into three groups by a computer-generated randomization PCA after arthroscopic rotator cuff repair. We hypothe- table (Random Allocation Software Version 1.0). Patients sized that [3] patients receiving ramosetron or ondanse- were allocated into three groups: ramosetron group, ondan- tron medications after arthroscopic rotator cuff repair setron group, or control group (normal saline IV). would have less postoperative emetic events in the early Initially, 42 patients were allocated to the ramosetron postoperative period than the control groups, [21] ramo- group and 43 to the ondansetron and control groups re- setron or ondansetron reduces postoperative emetic spectively. We excluded three patients in the ramosetron Lee et al. Journal of Orthopaedic Surgery and Research (2020) 15:523 Page 3 of 8 Fig. 1 CONSORT flow diagram. PCA, patient-controlled analgesia group and three in the control group according to the Patients were administered every 12 h for 3 days after defined exclusion criteria, leaving 122 patients (ramose- surgery with the following medications: 200 mg of tron group, n = 39; ondansetron group, n = 43; control celecoxib, 75 mg of pregabalin, and 650 mg of acet- group, n = 40) for analysis. aminophen. Rescue antiemetic (10 mg of metoclopra- mide, IV) or analgesic
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