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Acta Medica Iranica Apr 2017Postoperative nausea and vomiting (PONV) are one of the most common complications of anesthesia and without prophylactic intervention occurs by about one-third of... (Comparative Study)
Comparative Study Randomized Controlled Trial
Postoperative nausea and vomiting (PONV) are one of the most common complications of anesthesia and without prophylactic intervention occurs by about one-third of patients under general anesthesia. The aim of this study was to compare the efficacy of ondansetron and metoclopramide in reducing PONV after laparoscopic cholecystectomy. In this study, 60 patients undergoing laparoscopic cholecystectomy were randomly allocated into two equal groups (n=30), and in the first group 10 mg metoclopramide and in the second group 4 mg ondansetron preoperatively were injected. Nausea and vomiting and the need for rescue antiemetic treatment in recovery and 6 hr. and 6-24 hrs. After surgery were evaluated. Data were analyzed by SPSS software with chi-square test and analysis of variance (ANOVA). The incidence of nausea in metoclopramide was 43.3 % and in ondansetron was 33.3 %. The difference between two groups was not significant (P=0.6). The incidence of vomiting in metoclopramide was 20% and in ondansetron was 26.7%, and there was not any significant difference between intervention groups (P=0.12). For prevention of PONV after laparoscopic cholecystectomy, both metoclopramide and ondansetron are effective, and in preventing of nausea, ondansetron is more effective than metoclopramide, whereas there was not any significant difference between two drugs in preventing of vomiting.
Topics: Adult; Analysis of Variance; Anesthesia, General; Antiemetics; Cholecystectomy, Laparoscopic; Double-Blind Method; Female; Humans; Incidence; Male; Metoclopramide; Middle Aged; Ondansetron; Postoperative Nausea and Vomiting
PubMed: 28532137
DOI: No ID Found -
Medicine Oct 2022Postoperative nausea and vomiting (PONV) is a common complication in inpatient and outpatient settings. Multimodal approaches have been pursued to minimize this... (Randomized Controlled Trial)
Randomized Controlled Trial
A randomized controlled trial comparing incidences of postoperative nausea and vomiting after laparoscopic cholecystectomy for preoperative intravenous fluid loading, ondansetron, and control groups in a regional hospital setting in a developing country.
BACKGROUND
Postoperative nausea and vomiting (PONV) is a common complication in inpatient and outpatient settings. Multimodal approaches have been pursued to minimize this undesirable outcome. Despite consensus guidelines for the management of PONV have been updated and published for many years, data from our pilot study showed that patients with high-risk surgeries for PONV, laparoscopic cholecystectomy (LC), still hardly received perioperative PONV prophylaxis. This study aimed to compare the incidences of PONV in adult patients undergoing elective LC who were administered preoperative intravenous fluid loading, ondansetron, or neither fluid nor ondansetron in the setting of a regional hospital in a developing country.
METHODS
The study was designed as a prospective randomized controlled trial. The total of 171 patients was allocated to three groups: one received fluid loading with Ringer's lactate solution before the operation; the second received ondansetron; and the third group received neither.
RESULTS
In total, 156 patients were analyzed. Their demographic data, history of motion sickness/PONV, and smoking status were not significantly different. The overall incidences of PONV within 24 hours of surgery were 29.1% in the fluid group, 18.4% in the ondansetron group, and 25% in the control group, but the difference was not statistically significant (P = .442). In subgroup analysis, the incidences of PONV and PON in patients younger than 50 years old were significantly different among the three groups (P = .008). A post hoc analysis showed that patients under 50 years in the ondansetron group had significantly lower incidences of PONV and PON than those in the control and fluid groups. However, the incidences of morphine consumption and dizziness in the ondansetron group were significantly higher than those of the two other groups.
CONCLUSIONS
Neither the preoperative intravenous fluid loading nor the ondansetron affected PONV in patients aged 50 and older undergoing LC, compared with control. Ondansetron was beneficial for PON prophylaxis in patients under the age of 50, whereas preoperative intravenous fluid loading was considered a risk factor for PON in this population.
Topics: Adult; Humans; Middle Aged; Aged; Ondansetron; Postoperative Nausea and Vomiting; Cholecystectomy, Laparoscopic; Antiemetics; Incidence; Control Groups; Prospective Studies; Ringer's Lactate; Pilot Projects; Developing Countries; Double-Blind Method; Morphine; Hospitals
PubMed: 36281094
DOI: 10.1097/MD.0000000000031155 -
Anaesthesia Jan 1994The clinical development of ondansetron for the prevention and treatment of postoperative nausea and vomiting has been progressing for 5 years, and continues as new... (Review)
Review
The clinical development of ondansetron for the prevention and treatment of postoperative nausea and vomiting has been progressing for 5 years, and continues as new directions of research are being addressed. Large multicentre studies have demonstrated the efficacy of ondansetron in the prevention and treatment of postoperative nausea and vomiting, but no large comparator studies have been reported. Several studies are now being undertaken to compare ondansetron with other currently used antiemetics such as droperidol and metoclopramide, assessing efficacy, safety, pharmacoeconomic, and quality of life parameters. The majority of studies to date have been performed in gynaecological surgery patients receiving general anaesthesia--a population that experiences a high incidence of postoperative nausea and vomiting. Clinical development of ondansetron is therefore progressing to establish its efficacy in a wider surgical population, including paediatrics, the elderly, non-gynaecological surgery, and as retreatment in patients with failed prophylactic antiemetic therapy.
Topics: Adult; Aged; Analgesics, Opioid; Child; Drug Administration Schedule; Female; Humans; Nausea; Ondansetron; Postoperative Complications; Research Design; Vomiting
PubMed: 7907459
DOI: 10.1111/j.1365-2044.1994.tb03581.x -
Alimentary Pharmacology & Therapeutics Jun 2023Ondansetron may be beneficial in irritable bowel syndrome with diarrhoea (IBS-D). (Meta-Analysis)
Meta-Analysis
BACKGROUND
Ondansetron may be beneficial in irritable bowel syndrome with diarrhoea (IBS-D).
AIM
To conduct a 12-week parallel group, randomised, double-blind, placebo-controlled trial of ondansetron 4 mg o.d. (titrated up to 8 mg t.d.s.) in 400 IBS-D patients.
PRIMARY ENDPOINT
% responders using the Food and Drug Administration (FDA) composite endpoint. Secondary and mechanistic endpoints included stool consistency (Bristol Stool Form Scale) and whole gut transit time (WGTT). After literature review, results were pooled with other placebo-controlled trials in a meta-analysis to estimate relative risks (RR), 95% confidence intervals (CIs) and number needed to treat (NNT).
RESULTS
Eighty patients were randomised. On intention-to-treat analysis, 15/37 (40.5%; 95% CI 24.7%-56.4%) met the primary endpoint on ondansetron versus 12/43 (27.9%; 95% CI 14.5%-41.3%) on placebo (p = 0.19). Ondansetron improved stool consistency compared with placebo (adjusted mean difference - 0.7; 95% CI -1.0 to-0.3, p < 0.001). Ondansetron increased WGTT between baseline and week 12 (mean (SD) difference 3.8 (9.1) hours, versus placebo -2.2 (10.3) hours, p = 0.01). Meta-analysis of 327 patients from this, and two similar trials, demonstrated ondansetron was superior to placebo for the FDA composite endpoint (RR of symptoms not responding = 0.86; 95% CI 0.75-0.98, NNT = 9) and stool response (RR = 0.65; 95% CI 0.52-0.82, NNT = 5), but not abdominal pain response (RR = 0.95; 95% CI 0.74-1.20).
CONCLUSIONS
Although small numbers meant the primary endpoint was not met in this trial, when pooled with other similar trials meta-analysis suggests ondansetron improves stool consistency and reduces days with loose stool and urgency. Trial registration - http://www.isrctn.com/ISRCTN17508514.
Topics: Humans; Irritable Bowel Syndrome; Ondansetron; Diarrhea; Double-Blind Method; Feces; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 36866724
DOI: 10.1111/apt.17426 -
BioMed Research International 2022The study was aimed at designing and characterizing the ondansetron hydrochloride (OND) bearing agarose (AG), and hydroxypropyl methyl cellulose (HPMC) mucoadhesive...
The study was aimed at designing and characterizing the ondansetron hydrochloride (OND) bearing agarose (AG), and hydroxypropyl methyl cellulose (HPMC) mucoadhesive buccal films employing glycerol as a plasticizer. The buccal delivery of ondansetron hydrochloride was remarkably boosted by employing physical (iontophoresis) and chemical enhancement approaches (chemical penetration enhancers). To explore the influence of different formulation components, i.e., agarose, hydroxypropyl methyl cellulose (HPMC), and glycerol on various evaluating parameters, i.e., tensile strength, swelling index, ex vivo mucoadhesion time, and subsequently on in vitro drug release, a D-optimal design was opted. A buccal film bearing OND was mounted on bovine buccal mucosa for ex vivo permeation studies and impact of chemical and physical enhancement techniques on the permeation profile was also analysed. A linear release profile was revealed in in vitro drug release of OND over 60 minutes and outcomes ascertained the direct relationship between HPMC content and in vitro drug release and inverse relationship was depicted by AG content. The FTIR and DSC thermal analysis was executed to determine the physicochemical interactions and results exposed no chemical interactions between drug and polymers. The drug (OND) appeared as tiny crystals on smooth film surface during scanning electron microscopy (SEM) analysis. A notable enhancement in permeation flux, i.e., 761.02 g/min of OND during ex vivo permeation studies was witnessed after the application of current (0.5-1 mA) without any time lag and with enhancement ratio of 3.107. A time lag of 15 minutes, 19 minutes, and 26 minutes with permeation flux of 475.34 g/min, 399.35 g/min, and 244.81 g/min was observed after chemical enhancer pretreatment with propylene glycol, Tween 80, and passive, respectively. Rabbit was employed as the experimental animal for pharmacokinetic studies (in vivo) and cats for pharmacological activity (in vivo), and the results illustrated the enhanced bioavailablity (2.88 times) in the iontophoresis animal group when compared with the rabbits of control group. Likewise, a remarkable reduction in emesis events was recorded in cats of iontophoresis group. Conclusively, the histopathological examinations on excised buccal mucosa unveiled no severe necrotic or cytopathetic outcomes of current.
Topics: Animals; Cats; Cattle; Drug Delivery Systems; Glycerol; Hypromellose Derivatives; Iontophoresis; Methylcellulose; Mouth Mucosa; Ondansetron; Rabbits; Sepharose
PubMed: 35372569
DOI: 10.1155/2022/1662194 -
CNS Drug Reviews 2001Ondansetron is a selective 5-hydroxytryptamine(3) (5-HT(3)) receptor antagonist that has been introduced to clinical practice as an antiemetic for cancer... (Review)
Review
Ondansetron is a selective 5-hydroxytryptamine(3) (5-HT(3)) receptor antagonist that has been introduced to clinical practice as an antiemetic for cancer treatment-induced and anesthesia-related nausea and vomiting. Its use under these circumstances is both prophylactic and therapeutic. It has a superior efficacy, safety and pharmacoeconomic profile compared with other groups of antiemetics, namely antidopaminergics, antihistamines and anticholinergics. However, its place in the management of anticipatory and delayed vomiting in cancer treatment and as a rescue antiemetic in surgical patients needs to be further explored. Furthermore, recent animal and human research also reflects its possible novel application in the treatment of other disease states, such as alcoholism, cocaine addiction, opioid withdrawal syndrome, anxiety disorders, gastrointestinal motility disorders, Tourette's syndrome and pruritus. This review revisits the widespread physiological and pathological effects of 5-HT and discusses both the basic science literature and the clinical developments responsible for the conventional and novel uses of ondansetron. In addition, new discoveries relating to the effects of ondansetron on other receptors/channels and their possible therapeutic applications are presented.
Topics: Animals; Colonic Diseases, Functional; Humans; Ion Channels; Nausea; Ondansetron; Receptors, Serotonin; Serotonin Antagonists; Vomiting
PubMed: 11474424
DOI: 10.1111/j.1527-3458.2001.tb00195.x -
International Journal of Surgery... Nov 2016Considerable controversy exists regarding the efficacy of ondansetron in preventing postanesthesia shivering (PAS). We performed a meta-analysis of randomized controlled... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
Considerable controversy exists regarding the efficacy of ondansetron in preventing postanesthesia shivering (PAS). We performed a meta-analysis of randomized controlled trials to examine the controversy.
MATERIALS AND METHODS
Randomized controlled trials assessing the effect of ondansetron on the prevention of PAS were identified from electronic databases (PubMed and EMBASE). The meta-analysis was performed with the fixed-effect model or random-effect model according to heterogeneity.
RESULTS
Twelve trials randomized clinical trials met the inclusion criteria including 1205 subjects. Compared with placebo (saline), ondansetron was associated with a significant reduction of PAS (relative risk 0.33; 95% confidence interval, 0.21-0.51), Substantial heterogeneity was observed between trials (P = 0.0002; I = 71%). Trial sequential analysis showed that the cumulative Z-curve crossed the trial sequential monitoring boundary for benefit establishing sufficient and conclusive evidence. Meta-analysis with all five studies using a fixed-effects model suggested that ondansetron and meperidine have similar effects on the prevention of PAS (relative risk, 0.86; 95% confidence interval, 0.66-1.11), the heterogeneity was not significant (P = 0.34; I = 11%). No significant association of ondansetron with bradycardia was found both comparison with placebo and meperidine.
CONCLUSIONS
Treat with ondansetron is safe, and may reduce PAS. This finding encourages the use of ondansetron to prevent PAS, but, more high quality randomized clinical trials are still warranted to confirm the effects of different doses of ondansetron on PAS.
Topics: Anesthesia; Humans; Ondansetron; Randomized Controlled Trials as Topic; Serotonin Antagonists; Shivering
PubMed: 27632391
DOI: 10.1016/j.ijsu.2016.09.009 -
Pharmacogenetics and Genomics Jun 2019
Topics: Cytochrome P-450 CYP1A2; Cytochrome P-450 CYP2D6; Humans; Inactivation, Metabolic; Metabolic Networks and Pathways; Ondansetron; Receptors, Serotonin, 5-HT3; Serotonin; Serotonin Antagonists; Tropisetron
PubMed: 30672837
DOI: 10.1097/FPC.0000000000000369 -
The Journal of International Medical... Oct 2019We conducted a systematic literature search and meta-analysis to identify randomized controlled trials (RCTs) comparing the efficacy and safety of ramosetron versus... (Comparative Study)
Comparative Study Meta-Analysis
Comparison of ramosetron and ondansetron for the prevention of postoperative nausea and vomiting in patients undergoing laparoscopic surgery: a meta-analysis of randomized controlled trials.
OBJECTIVE
We conducted a systematic literature search and meta-analysis to identify randomized controlled trials (RCTs) comparing the efficacy and safety of ramosetron versus ondansetron for the prevention of postoperative nausea and vomiting (PONV; PON and POV, respectively) in patients undergoing laparoscopic surgery.
METHODS
The electronic databases PubMed, EMBASE, Web of Science, and Cochrane Library were searched up to March 2019 to identify relevant studies.
RESULTS
The final pooled analysis included 6 RCTs and revealed that postoperative treatment with ramosetron at 24 to 48 hours after surgery significantly reduced the incidence of PON and POV relative to treatment with ondansetron. In a subgroup analysis, ramosetron 0.3 mg tended to reduce PON (0–2 hours) and POV (24–48 hours) more effectively than ondansetron 4 mg. However, no statistical difference was observed between ramosetron 0.3 mg and ondansetron 8 mg in terms of the reduction of PON or POV during any time interval within the first 48 hours after surgery.
CONCLUSIONS
Our results indicate that ramosetron 0.3 mg is superior to ondansetron 4 mg and comparable to ondansetron 8 mg for PONV prophylaxis after laparoscopic surgery.
Topics: Adult; Benzimidazoles; Humans; Laparoscopy; Middle Aged; Ondansetron; Postoperative Nausea and Vomiting; Publication Bias; Randomized Controlled Trials as Topic; Risk
PubMed: 31638464
DOI: 10.1177/0300060519871171 -
Clinical and Translational Science Feb 2023The goal of this study was to determine whether CYP2D6 metabolizer status within the ondansetron-treated pediatric tonsillectomy population is associated with risk of...
The goal of this study was to determine whether CYP2D6 metabolizer status within the ondansetron-treated pediatric tonsillectomy population is associated with risk of postoperative nausea and vomiting (PONV) in the post-anesthesia care unit. We conducted a retrospective cohort study of pediatric patients (<18 years) who underwent tonsillectomy and received ondansetron on the day of the procedure. Data were obtained from BioVU, an institutional biobank that links DNA to de-identified electronic health record data. Subjects were tested for 10 CYP2D6 allelic variants and copy number variation, and genotype data translated into CYP2D6 metabolizer status. The cohort included 652 individuals, 105 (16.1%) of whom had PONV. Rates of PONV were similar across groups: ultrarapid metabolizers (UMs), 1 of 9 (11.1%); normal metabolizers (NMs), 64 of 354 (18.1%); intermediate metabolizers (IMs), 33 of 234 (14.1%); poor metabolizers (PMs), 6 of 39 (15.4%); and ambiguous phenotypes, 1 of 16 (6.3%). In multivariable analysis adjusted for age, sex, and time under anesthesia, CYP2D6 metabolizer status was not associated with PONV, with an odds ratio of 1.37 (95% confidence interval 0.9, 2.1) when comparing PM/IM versus NM/UM. In this large pediatric population, no significant differences were detected for PONV based on CYP2D6 metabolizer status. Further investigation is needed to determine mechanisms for ondansetron inefficacy in children.
Topics: Child; Humans; Ondansetron; Cytochrome P-450 CYP2D6; Postoperative Nausea and Vomiting; DNA Copy Number Variations; Retrospective Studies; Tonsillectomy
PubMed: 36350309
DOI: 10.1111/cts.13447