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Korean Journal of Anesthesiology Sep 2009Postoperative nausea and vomiting (PONV) is a common problem in patients undergoing thyroidectomy. In this study we evaluated the effects of prophylactic dolasetron...
BACKGROUND
Postoperative nausea and vomiting (PONV) is a common problem in patients undergoing thyroidectomy. In this study we evaluated the effects of prophylactic dolasetron and/or induction with propofol on PONV.
METHODS
Two hundred three patients scheduled thyroidectomy under general anesthesia with sevoflurane were included and were randomly allocated to one of four groups. In control (group C) and dolasetron groups (group D), the patients received thiopental sodium 4-5 mg/kg intravenously for the induction of anesthesia, and the patients in group D received prophylactic intravenous dolasetron 210 microgram/kg. In propofol (group P) and dolasetron + propofol groups (group D + P), the patients received propofol 2 mg/kg intravenously for the induction of anesthesia, and the patients in group D + P received prophylactic intravenous dolasetron 210 microgram/kg. The incidence and severity of PONV, the need for rescue antiemetics, adverse events were assessed during 0 to 1 hour and 1 to 24 hours postoperatively.
RESULTS
During the first 24 hours after anesthesia, the incidences of PONV and postoperative vomiting were significantly reduced in group D + P compared with group C (P < 0.05, respectively). There were no significant differences in postoperative nausea, need for rescue antiemetics, severity of PONV, and adverse events of antiemetics among the four groups.
CONCLUSIONS
In patients with thyroidectomy, combination of prophylactic dolasetron administration and induction with propofol was found to reduce the incidence of PONV during the first 24 hours after anesthesia, compared with that of routine induction with thiopental sodium.
PubMed: 30625880
DOI: 10.4097/kjae.2009.57.3.320 -
Chinese Clinical Oncology Apr 2020Review the clinical evidence of tropisetron or palonosetron, an old- and new-generation serotonin (5-hydroxytryptamine) type 3 (5-HT3) receptor antagonist (RA),... (Review)
Review
Review the clinical evidence of tropisetron or palonosetron, an old- and new-generation serotonin (5-hydroxytryptamine) type 3 (5-HT3) receptor antagonist (RA), respectively, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with cancer, and evaluate any difference in efficacy trends. A literature search of the EMBASE and PubMed databases was performed to identify publications of intravenous (IV) tropisetron (generic forms or Navoban®) for the treatment of CINV in patients with various cancers. Data from the pivotal clinical studies evaluating the IV formulation of Aloxi® (palonosetron HCl) were also considered. The effectiveness and safety of each antiemetic was summarized. Sixteen papers for tropisetron fulfilled the inclusion criteria and were extracted for full analysis; publications from six pivotal palonosetron clinical trials were considered. No direct data comparisons could be made between the two drugs, due to the varying definitions of efficacy endpoints between studies. For tropisetron, the rates of no emesis were lower in patients receiving highly emetogenic chemotherapy (HEC) versus moderately emetogenic chemotherapy (MEC). For palonosetron, the rates of complete response (no emesis, no rescue medication) were comparable in the MEC and HEC settings, demonstrating the effectiveness of this agent in patients receiving HEC. Both antiemetics offered some protection against nausea, although lower rates of no nausea were achieved compared with rates of no emesis. Two trials that evaluated the efficacy of palonosetron and tropisetron within the same study reported that palonosetron was more effective than tropisetron in controlling delayed vomiting in the HEC and MEC settings, with significantly higher rates of no emesis observed (P≤0.01). Palonosetron was non-inferior or more efficacious in controlling CINV compared with other older 5-HT3RAs, such as dolasetron, ondansetron, and granisetron. Conversely, tropisetron was no more efficacious than ondansetron or granisetron. Both tropisetron and palonosetron were generally well tolerated, with adverse event profiles consistent with drugs of this class (e.g., headache, constipation, and diarrhea). These data suggest that palonosetron is a highly selective prophylactic agent that may have an improved therapeutic profile compared with tropisetron, and is a feasible treatment option for controlling CINV in patients with cancer.
Topics: Antineoplastic Agents; Female; Humans; Male; Nausea; Neoplasms; Palonosetron; Tropisetron; Vomiting
PubMed: 31865713
DOI: 10.21037/cco.2019.11.02 -
Cancer Research and Treatment Dec 2004The aim of this study is to compare the antiemetic efficacy and tolerability of intravenous dolasetron mesylate and ondansetron in the prevention of acute and delayed...
Open-label, randomized comparison of the efficacy of intravenous dolasetron mesylate and ondansetron in the prevention of acute and delayed cisplatin-induced emesis in cancer patients.
PURPOSE
The aim of this study is to compare the antiemetic efficacy and tolerability of intravenous dolasetron mesylate and ondansetron in the prevention of acute and delayed emesis.
MATERIAL AND METHODS
From April 2002 through October 2002, a total of 112 patients receiving cisplatin- based combination chemotherapy were randomized to receive a single i.v. dose of dolasetron 100 mg or ondansetron 8 mg, 30 minutes before the initiation of chemotherapy. In the ondansetron group, two additional doses of ondansetron 8 mg were given at intervals of 2 to 4 hours. To prevent delayed emesis, dolasetron 200 mg p.o. daily or ondansetron 8 mg p.o. bid was administered from the 2(nd) days to a maximum of 5 days. The primary end point was the proportion of patients that experienced no emetic episodes and required no rescue medication (complete response, CR) during the 24 hours (acute period) and during Day 2 to Day 5+/-2 days (delayed period), after chemotherapy. The secondary end points included the incidence and severity of emesis.
RESULTS
105 patients were evaluable for efficacy. CR rates during the acute period were 36.0% for a single dose of dolasetron 100 mg, and 43.6% for three doses of ondansetron 8 mg. CR rates during the delayed period were 8.0% and 10.9%, respectively. There was no significant difference in the efficacy between the two groups. Adverse effects were mostly mild to moderate and not related to study medication.
CONCLUSIONS
A single i.v. dose of dolasetron 100 mg is as effective as three i.v. doses of ondansetron 8 mg in preventing acute and delayed emesis after cisplatin-based chemotherapy, with a comparable safety profile.
PubMed: 20368831
DOI: 10.4143/crt.2004.36.6.372 -
BMC Medicine Dec 2016Although serotonin (5-HT) receptor antagonists are effective in reducing nausea and vomiting, they may be associated with increased cardiac risk. Our objective was to... (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
Although serotonin (5-HT) receptor antagonists are effective in reducing nausea and vomiting, they may be associated with increased cardiac risk. Our objective was to examine the comparative safety and effectiveness of 5-HT receptor antagonists (e.g., dolasetron, granisetron, ondansetron, palonosetron, tropisetron) alone or combined with steroids for patients undergoing chemotherapy.
METHODS
We searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials from inception until December 2015 for studies comparing 5-HT receptor antagonists with each other or placebo in chemotherapy patients. The search results were screened, data were abstracted, and risk of bias was appraised by pairs of reviewers, independently. Random-effects meta-analyses and network meta-analyses (NMAs) were conducted.
RESULTS
After screening 9226 citations and 970 full-text articles, we included 299 studies (n = 58,412 patients). None of the included studies reported harms for active treatment versus placebo. For NMAs on the risk of arrhythmia (primary outcome; three randomized controlled trials [RCTs], 627 adults) and mortality (secondary outcome; eight RCTs, 4823 adults), no statistically significant differences were observed between agents. A NMA on the risk of QTc prolongation showed a significantly greater risk for dolasetron + dexamethasone versus ondansetron + dexamethasone (four RCTs, 3358 children and adults, odds ratio 2.94, 95% confidence interval 2.13-4.17). For NMAs on the number of patients without nausea (44 RCTs, 11,664 adults, 12 treatments), number of patients without vomiting (63 RCTs, 15,460 adults, 12 treatments), and number of patients without chemotherapy-induced nausea or vomiting (27 RCTs, 10,924 adults, nine treatments), all agents were significantly superior to placebo. For a NMA on severe vomiting (10 RCTs, 917 adults), all treatments decreased the risk, but only ondansetron and ramosetron were significantly superior to placebo. According to a rank-heat plot with the surface under the cumulative ranking curve results, palonosetron + steroid was ranked the safest and most effective agent overall.
CONCLUSIONS
Most 5-HT receptor antagonists were relatively safe when compared with each other, yet none of the studies compared active treatment with placebo for harms. However, dolasetron + dexamethasone may prolong the QTc compared to ondansetron + dexamethasone. All agents were effective for reducing risk of nausea, vomiting, and chemotherapy-induced nausea or vomiting.
TRIAL REGISTRATION
This study was registered at PROSPERO: ( CRD42013003564 ).
Topics: Adult; Antiemetics; Antineoplastic Agents; Drug Therapy, Combination; Glucocorticoids; Humans; Nausea; Network Meta-Analysis; Serotonin 5-HT3 Receptor Antagonists; Vomiting
PubMed: 28007031
DOI: 10.1186/s12916-016-0761-9 -
Anesthesiology Feb 1999
Topics: Anesthesia; Antiemetics; Granisetron; Humans; Indoles; Ondansetron; Postoperative Nausea and Vomiting; Quinolizines
PubMed: 9952135
DOI: 10.1097/00000542-199902000-00003 -
The Cochrane Database of Systematic... Jul 2006Drugs can prevent postoperative nausea and vomiting, but their relative efficacies and side effects have not been compared within one systematic review. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Drugs can prevent postoperative nausea and vomiting, but their relative efficacies and side effects have not been compared within one systematic review.
OBJECTIVES
The objective of this review was to assess the prevention of postoperative nausea and vomiting by drugs and the development of any side effects.
SEARCH STRATEGY
We searched The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 2, 2004), MEDLINE (January 1966 to May 2004), EMBASE (January 1985 to May 2004), CINAHL (1982 to May 2004), AMED (1985 to May 2004), SIGLE (to May 2004), ISI WOS (to May 2004), LILAC (to May 2004) and INGENTA bibliographies.
SELECTION CRITERIA
We included randomized controlled trials that compared a drug with placebo or another drug, or compared doses or timing of administration, that reported postoperative nausea or vomiting as an outcome.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed trial quality and extracted outcome data.
MAIN RESULTS
We included 737 studies involving 103,237 people. Compared to placebo, eight drugs prevented postoperative nausea and vomiting: droperidol, metoclopramide, ondansetron, tropisetron, dolasetron, dexamethasone, cyclizine and granisetron. Publication bias makes evidence for differences among these drugs unreliable. The relative risks (RR) versus placebo varied between 0.60 and 0.80, depending upon the drug and outcome. Evidence for side effects was sparse: droperidol was sedative (RR 1.32) and headache was more common after ondansetron (RR 1.16).
AUTHORS' CONCLUSIONS
Either nausea or vomiting is reported to affect, at most, 80 out of 100 people after surgery. If all 100 of these people are given one of the listed drugs, about 28 would benefit and 72 would not. Nausea and vomiting are usually less common and, therefore, drugs are less useful. For 100 people, of whom 30 would vomit or feel sick after surgery if given placebo, 10 people would benefit from a drug and 90 would not. Between one to five patients out of every 100 people may experience a mild side effect, such as sedation or headache, when given an antiemetic drug. Collaborative research should focus on determining whether antiemetic drugs cause more severe, probably rare, side effects. Further comparison of the antiemetic effect of one drug versus another is not a research priority.
Topics: Antiemetics; Humans; Postoperative Nausea and Vomiting; Randomized Controlled Trials as Topic
PubMed: 16856030
DOI: 10.1002/14651858.CD004125.pub2 -
Cancer Management and Research 2012Chemotherapy-induced nausea and vomiting and postoperative nausea and vomiting are one of the most frequent but also very concerning consequences for patients undergoing...
Chemotherapy-induced nausea and vomiting and postoperative nausea and vomiting are one of the most frequent but also very concerning consequences for patients undergoing chemotherapy or surgical procedures under general anesthesia. There are a variety of mechanisms involved in the activation of nausea and vomiting. Serotonin, a ubiquitous central and peripheral neurotransmitter, is thought to be the predominant mediator of the perception of nausea and triggering of the vomiting response in both the brain and the periphery via the 5-hydroxytryptamine type 3 (5-HT(3)) receptor pathways. 5-HT(3) receptor antagonists disrupt this pathway, largely at the level of the vagal afferent pathways, to decrease nausea and vomiting. This review will focus on dolasetron, an older but sill commonly used 5-HT(3) receptor antagonist and its multimodal mechanism of action, safety and tolerability, patient considerations, and a review of the current literature on its use to combat both chemotherapy-induced and postoperative nausea and vomiting in these two important patient populations.
PubMed: 22427733
DOI: 10.2147/cmar.s15545 -
Therapeutics and Clinical Risk... 2021Our aim was to compare the antiemetic efficacy of the triple combination of aprepitant, dolasetron and dexamethasone with the combination of dolasetron and dexamethasone...
PURPOSE
Our aim was to compare the antiemetic efficacy of the triple combination of aprepitant, dolasetron and dexamethasone with the combination of dolasetron and dexamethasone for chemotherapy-induced nausea and vomiting (CINV) in hepatocellular carcinoma (HCC) patients receiving hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin, fluorouracil and leucovorin (FOLFOX).
PATIENTS AND METHODS
This was a retrospective study. In the dolasetron plus dexamethasone group (D group), the patients received dolasetron (100 mg, i.v., on day 1) and dexamethasone (10 mg, i.v., on day 1) 30 min before starting administration of chemotherapeutic drugs. In the aprepitant plus dolasetron and dexamethasone group (AD group), the patients received dolasetron and dexamethasone as described above, and aprepitant (125 mg, p.o.) on day 1 followed by 80 mg on days 2 and 3. The primary endpoint was the complete response rate (CR, defined as no emetic episodes and no rescue medication use) during the first cycle of hepatic arterial infusion chemotherapy.
RESULTS
Between January 2018 and August 2019, 302 eligible patients were included: 197 in AD group and 105 in D group. Patients in AD group had significantly higher complete response rates than those in D group during the first cycle (85.8% vs 71.4%, P = 0.003) and all cycles (73.6% vs 49.5%, P<0.001). Patients in AD group had lower rescue therapy (1.5% vs 26.7%, P<0.001) and lower incidence of disruption related to chemotherapy-induced nausea and vomiting (0.5% vs 6.7%, P = 0.002) than patients in D group.
CONCLUSION
Aprepitant, dolasetron plus dexamethasone is more effective to prevent chemotherapy-induced nausea and vomiting in hepatocellular carcinoma patients treated with FOLFOX-HAIC therapy than dolasetron plus dexamethasone.
PubMed: 33519205
DOI: 10.2147/TCRM.S283192 -
Supportive Care in Cancer : Official... Jan 1997The potent serotonin receptor (5-HT3) antagonists are new highly selective agents for the prevention and control of chemotherapy-induced nausea and vomiting that have... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
A double-blind, multicentre comparison of intravenous dolasetron mesilate and metoclopramide in the prevention of nausea and vomiting in cancer patients receiving high-dose cisplatin chemotherapy.
The potent serotonin receptor (5-HT3) antagonists are new highly selective agents for the prevention and control of chemotherapy-induced nausea and vomiting that have been shown to be comparable to or more effective than traditional metoclopramide regimens. This study was designed to compare the antiemetic efficacy of dolasetron and metoclopramide in chemotherapy-naive and non-naive cancer patients receiving high-dose cisplatin-containing chemotherapy. This multicentre, double-blind, randomized trial compared the efficacy and safety of single i.v. doses of dolasetron mesilate salt (1.2 or 1.8 mg/kg) and metoclopramide (7 mg/kg) in 226 patients for the prevention of acute emesis and nausea associated with the administration of high-dose (> or = 80 mg/m2) cisplatin. Efficacy and safety were evaluated for 24 h. Complete responses were achieved by 57%, 48%, and 35% of patients given dolasetron mesilate 1.8 mg/kg (P = 0.0009 vs metoclopramide), dolasetron mesilate 1.2 mg/kg (P = 0.0058 vs metoclopramide), and metoclopramide, respectively. Overall, dolasetron was significantly more effective than metoclopramide for time to first emetic episode, nausea, patient satisfaction, and investigator global assessment of efficacy. Males, chemotherapy-naive patients, and alcoholics had higher response rates. Dolasetron was well tolerated, with mild-to-moderate headache most commonly reported. Twelve percent of patients receiving metoclopramide reported extrapyramidal symptoms compared with 0% of patients receiving dolasetron. In conclusion, dolasetron mesilate was effective for the prevention of CINV with high-dose cisplatin. Single i.v. doses of dolasetron mesilate were more effective than 7 mg/kg metoclopramide in preventing nausea and vomiting induced by highly emetogenic cisplatin-containing chemotherapy. In addition, 1.8 mg/kg dolasetron mesilate consistently produced the highest response rates and appears to be the most effective dose for further clinical development.
Topics: Acute Disease; Alcoholism; Antiemetics; Antineoplastic Agents; Basal Ganglia Diseases; Cisplatin; Double-Blind Method; Female; Headache; Humans; Indoles; Injections, Intravenous; Male; Metoclopramide; Middle Aged; Nausea; Neoplasms; Patient Satisfaction; Quinolizines; Remission Induction; Safety; Serotonin Antagonists; Sex Factors; Vomiting
PubMed: 9010986
DOI: 10.1007/BF01681958