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The efficacy of Domperidone (R 33812) in the treatment of postoperative vomiting. A double-blind study with a placebo.

One hundred patients (14-82 years) were given either domperidone 10 mg I.V. or a placebo after they had vomited postoperatively. The patients were then observed for six hours. A supplementary injection of domperidone 10 mg I.V. from an open supply was given if required. In the placebo group 47.9% of patients needed another injection but only 25% of patients in the domperidone group (p less than 0.01). Vomiting occurred later after domperidone than after the placebo (p less than 0.01). At the end of six hours 74% of patients in the domperidone group had no recurrence of vomiting compared with 38% in the control group. In this study neither vomiting nor the efficacy of domperidone were found to be related to the type of surgery, the type of anaesthetic or the physical status (ASA I-III) of the patient (p greater than 0.05).

Adolescent↗

Anticipatory vomiting in women receiving cyclophosphamide, methotrexate, and 5-FU (CMF) adjuvant chemotherapy for breast carcinoma.

To determine the incidence of anticipatory vomiting (AV) and postchemotherapy nausea and vomiting (PCNV) in women receiving cyclophosphamide, methotrexate, and 5-FU (CMF) adjuvant chemotherapy for breast carcinoma, we studied 52 women randomized to two regimens (standard-dose and low-dose) of CMF. Charts were reviewed for the cycle of onset of AV and PCNV, the severity of PCNV, and relationships of these syndromes to CMF dose and protocol compliance. Among the 52 patients, AV occurred in 17 (33%), while PCNV was experienced by 46 (88%). Severe PCNV (defined as uncontrolled nausea and/or vomiting interfering with performance of daily activities) occurred in 22 of 52 (42%) women. Eighteen of 23 (78%) women receiving standard-dose CMF experienced severe PCNV, and 13 of these had AV. Patients in whom severe PCNV began before cycle 4 were more likely to develop AV than women in whom PCNV began later (P less than 0.01). Ten of 52 (19%) patients discontinued CMF adjuvant chemotherapy because of nausea and vomiting; seven of the ten (70%) were receiving standard-dose CMF and seven had experienced AV. This study demonstrates that both AV an PCNV are significant toxic effects that not only affect the quality of life of a woman receiving CMF chemotherapy for breast cancer but also limit the ability of the clinician to provide maximum therapy to woman at high risk of recurrence of breast carcinoma.

Activities of Daily Living↗

Gastric stasis and vomiting: behavioral treatment.

A patient is described in whom gastric stasis and vomiting of 28-yr duration were successfully treated with behavior therapy. Failure of conventional medical treatment in the face of continued vomiting led to consideration for surgery. The need for surgery was obviated by the successful application of exposure and response prevention, which resulted in a complete elimination of vomiting. Changes were produced, not only in the overt behavioral manifestation (vomiting) but in gastrointestinal motility as well. Although there was a lag, gastric emptying returned to normal. The improvements were maintained at over 1-yr follow-up study.

Behavior Therapy↗

Postoperative nausea and vomiting treated with domperidone (r 33812) an open and a double-blind study.

The effect of domperidone on postoperative nausea and vomiting was evaluated in two consecutive studies. Fifty-eight patients with postoperative nausea and vomiting were included in an open pilot study and 38 other patients in a double-blind trial. In the first study 4 mg of domperidone was found to be significantly superior to 2 mg, in controlling nausea and vomiting. In the double-blind trial, vomiting recurred significantly later in domperidone than in placebo-treated patients. Side-effects were not seen nor reported in either study.

Antiemetics↗

[Comparison of granisetron alone and granisetron plus dexamethasone or hydroxyzine hydrochloride for the prevention of nausea and vomiting during chemotherapy including cisplatin].

The comparative study among granisetron alone and granisetron combined with hydroxyzine hydrochloride or dexamethasone was undertaken for the prevention of nausea and vomiting during chemotherapy including cisplatin in patients with advanced head and neck carcinomas. The results indicated that the combination antiemetic therapies were more effective than granisetron alone for acute nausea and vomiting, whereas a significant difference was not observed among these three groups in the acute adverse effects. Otherwhile, there were statistically significant improvements in the prevention of delayed nausea and vomiting for patients receiving granisetron combined with the other antiemetic drugs, especially the combination antiemetic therapy with dexamethasone. These results confirm the antiemetic activity of granisetron in acute nausea and vomiting induced by cisplatin and show that it has an additive effect in combination with dexamethasone.

Adult↗

Ondansetron, an antagonist of 5-HT3 receptors, in the treatment of antineoplastic drug-induced nausea and vomiting in children.

The aim of this study was to evaluate the efficacy and safety of ondansetron, an antagonist of 5-hydroxytryptamine type 3 (serotonin 3) (5-HT3) receptors, in controlling nausea and vomiting induced by antineoplastic therapy in children affected by cancer. Six patients affected by nausea and vomiting due to antineoplastic drugs were treated with ondansetron (4 mg/m2). Urinary samples for the assay of serotonin and 5-hydroxy-indoleacetic acid (5-HIAA) were collected 24 hr before antineoplastic drug treatment, 24 hours after the start of antineoplastic therapy and, 24 hr after the start of ondansetron therapy. All patients were affected by nausea and vomiting within two to four hr after the antineoplastic treatment. Urinary concentrations of serotonin and 5-HIAA were higher and statistically significant (P < 0.01) with respect to basal values. Treatment with ondansetron significantly reduced the number of episodes of nausea and vomiting, as well as the urinary values for serotonin and 5-HIAA.

Antineoplastic Combined Chemotherapy Protocols↗

Optimal combination therapy with Navoban (tropisetron) in patients with incomplete control of chemotherapy-induced nausea and vomiting. The Belgian Navoban Group.

Even with the availability of potent and selective serotonin antagonists, chemotherapy-induced nausea and vomiting remain a major problem for many patients. This study aims to evaluate the benefit of combination therapy based on Navoban (tropisetron) in patients who had incomplete control of nausea and/or vomiting induced by chemotherapy when using Navoban as a single antiemetic agent. In their first chemotherapy course, 1072 patients planned to receive at least two identical cycles of emetogenic chemotherapy were treated with 5 mg Navoban once daily. To evaluate three treatments additional to the recommended 5 mg once-daily Navoban regimen during Course 2 in those patients who had shown incomplete control of nausea and/or vomiting on any day of Course 1, a 2 x 2 x 2 factorial design was employed. Of these patients, 445 were centrally randomised to receive an additional dose of open-label dexamethasone (Day 1, 0.2 mg/kg i.v.; Days 2-6, 8 mg p.o.) and/or open-label alizapride (Day 1, 100 mg i.v. and 4 x 50 mg p.o.; Days 2-6, 4 x 5 mg p.o.) and/or double-blind Navoban--that is, doubling the dose to 10 mg once daily or placebo. Complete response rates during Course 1 (CRR, no nausea and no vomiting) were, for Day 1, 72% and for Days 1-6, 48%. More complete responders were observed when dexamethasone was added during Course 2, both on Day 1 (76% vs. 66%, p = 0.020) and on Days 1-6 (50% vs. 34%, p = 0.0004).(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

Comparison of the combined effects of atropine and neostigmine with atropine and edrophonium on the occurrence of postoperative nausea and vomiting.

To investigate the effects of different types of anticholinesterase on the incidence of the postoperative nausea and vomiting, 100 ASA class I-II adult premenopausal female patients undergoing elective lower abdominal surgery were randomized into two groups. In both groups, anesthesia was induced with thiopental and fentanyl and 50% nitrous oxide and 0.5-1.5% of isoflurane were used for anesthetic maintenance with succinylcholine 1 approximately 1.5 mg/kg for intubation and atracurium 0.3 mg/kg/hr for maintenance of muscle relaxation. Patients received reversal agents for neuromuscular blockade after operation when the evoked train-of-four (TOF) count returned to four visual responses. A mixture of atropine 8 micrograms/kg and edrophonium 0.75 mg/kg was given to the first group of patients while atropine 15 micrograms/kg and neostigmine 40 micrograms/kg was given to another group of patients. All the patients were observed for the occurrence of nausea or vomiting for 2 hours after the operation in the recovery room. The incidence of nausea was not statistically significantly different in both groups (20% in neostigmine group and 26% in edrophonium group). The occurrence of vomiting was also similar in both groups (8% in neostigmine group and 6% in edrophonium group). We concluded that there were no difference in the incidence of postoperative nausea or vomiting with the use of either neostigmine or edrophonium with atropine for antagonizing neuromuscular blockade after the lower abdominal surgery.

Adult↗

Oral ondansetron for preventing nausea and vomiting.

Available clinical data on the use of oral ondansetron for the prevention of nausea and vomiting in patients undergoing cancer chemotherapy or surgery are reviewed. Injectable ondansetron hydrochloride is very effective in preventing nausea and vomiting associated with even the most emetogenic antineoplastic drugs. In December 1992, 4- and 8-mg oral tablets (ondansetron hydrochloride dihydrate) became available. Many of the clinical trials of oral ondansetron have not compared it with other antiemetics or have compared it only with placebo. Oral ondansetron has shown efficacy in such trials, but the standard of care for preventing chemotherapy-induced emesis is not placebo. Studies involving a prechemotherapy i.v. dose of ondansetron followed by oral therapy have shown high response rates for the whole study period; however, when day 1 is excluded, the results are not impressive for the remainder of the study period. It seems that the period beyond 24 hours is when oral ondansetron is effective, and that efficacy against acute emesis is due to i.v. ondansetron. Clinical trials in which oral ondansetron and oral metoclopramide were compared showed ondansetron to be, at best, equal to metoclopramide. One study showed the combination of dexamethasone and metoclopramide to be superior to oral ondansetron. Oral ondansetron is more effective than placebo in preventing post-operative nausea and vomiting in gynecologic surgery patients; however, there have been no comparative studies, and routine use of antiemetics in most surgical patients may be unnecessary because newer anesthetics are less emetogenic. Although the adverse effects of oral ondansetron are milder than those of standard antiemetics, this may not compensate for the drug's high cost. Oral ondansetron is not superior to traditional antiemetics for the prevention of nausea and vomiting caused by chemotherapy or surgery.

Animals↗

[Clinical effects of granisetron and methylprednisolone against nausea, vomiting and anorexia induced by cisplatin].

We investigated the usefulness of concurrent therapy of granisetron with methylprednisolone sodium for on nausea, vomiting and anorexia induced by chemotherapy, including cisplatin, in patients with oral cancer. Group A: 10 patients who were on concurrent therapy of granisetron (3.0 mg/body) with methylprednisolone sodium (750 mg/body) (19 courses). Group B: 13 patients who were given coktail therapy of methylprednisolone sodium (750 mg/body) as the base drug plus metoclopramide (46.7 mg/body on average) and domperidone (82.9 mg/body on average) (21 courses). Efficacy rates for nausea, vomiting and anorexia were 89.4%, 100% and 100% in group A, and 33.3%, 47.6% and 42.9% in group B, respectively. Statistical significance was found with nausea, vomiting and anorexia (p < 0.01). The results suggest usefulness of concurrent therapy of granisetron with methylpredonisolone sodium for cisplatin-induced nausea, vomiting and anorexia.

Adult↗

Minimal middle ear effusion: an indication for ventilation tubes in infants with protracted vomiting.

We have lately treated six infants hospitalized in our hospital for persistent vomiting and failure to thrive with no overt explanation for their condition. Examination of the ears of these infants revealed various degrees of serous otitis media. They all had myringostomies and insertion of ventilation tubes after which they stopped vomiting and gained in weight. We wish to revive the often overlooked association between protracted vomiting and middle ear effusion. It seems that minimal degrees of middle ear effusion may cause vomiting and patients with this condition may benefit from ventilation tubes.

Failure to Thrive↗

[Ictus emeticus. Vomiting as epileptic manifestation].

Autonomic and visceral phenomena are well-known manifestations of epileptic seizures, but recurrent vomiting as ictal epileptic events are less known. Three patients with ictus emeticus, i.e. with nausea and vomiting as their main ictal symptoms, are described. Vomiting is a complex symptom preceded by several phenomena in the gastrointestinal tract and transmitted by the vagal nerve to the vomiting centre in the lateral reticular formation of the medulla oblongata. This autonomic centre in the brain stem is influenced by several cerebral structures. There is both experimental and clinical evidence to support the hypothesis that epileptic disturbances in the insula and the mesial temporal structures are responsible for ictus emeticus.

Adult↗

Evaluation of methylnaltrexone for the reduction of postoperative vomiting and nausea incidences.

We examined the effect of methylnaltrexone on the incidence of postoperative nausea and vomiting in a prospective double-blind placebo controlled study. One hundred and twenty female patients undergoing laparoscopic major gynecological surgery were allocated randomly to receive either 20 mg methylnaltrexone or placebo IV at the end of surgery. Postoperative nausea and vomiting was evaluated for 6 h after admission to the PACU and assessed by number of episodes and degree of severity. The incidences of nausea and vomiting for the placebo group were 27 and 18 percent, respectively. The corresponding values for the methylnaltrexone group were 20 and 10 percent. We conclude that methylnaltrexone did not prevent nor significantly reduced the incidence and severity of postoperative nausea and vomiting following a balanced anesthetic technique in gynecological procedures.

Adult↗

[Study on clinical effect of a continuous intravenous infusion of azasetron against nausea and vomiting induced by anticancer drugs including CDDP].

Azasetron, a selective 5-HT3 receptor antagonist, has been previously shown to be highly effective in the prophylaxis of nausea and vomiting induced by anticancer drugs and is widely used in the clinical setting in Japan. In order to improve the antiemetic effect of azasetron, we designed a continuous intravenous infusion method of this drug and compared the antiemetic effect of this method with that of standard bolus intravenous injection on nausea and vomiting associated with anticancer drugs including 75 mg/m2 cisplatin (CDDP). A continuous group is intravenous bolus injection of 2.5 mg azasetron followed by 7.5 mg continuous intravenous infusion for 24 hrs, and a bolus group is intravenous bolus injection of 10 mg azasetron. The inhibitory effect on nausea of the continuous group was significantly superior to those of the bolus group on day 3 and 4 (p < 0.05) and inhibitory effect on vomiting of the continuous group was significantly superior to those of bolus group on day 2 (p < 0.05). No adverse effects were observed in either group of this study. From these data, continuous intravenous infusion of azasetron was considered to be highly effective in prophylaxis of nausea and vomiting induced by anticancer drugs.

Adult↗

[Efficacy of granisetron rescue therapy for nausea and vomiting induced by cancer chemotherapies in urogenital malignant tumor].

In this study, the usefulness of granisetron rescue therapy for nausea and vomiting induced by cancer chemotherapies, including CDDP, was examined. Granisetron was given to twenty patients with urogenital malignant tumor by iv infusion for thirty minutes after the onset of nausea or vomiting. Nausea disappeared in 15 out of 20 patients (75%), 8 of whom (40%) experienced its disappearance while the granisetron was being administered. Vomiting was perfectly controlled in 5 out of 20 patients (25%) for 24 hours after the granisetron administration. No adverse event seemingly due to granisetron was observed. The result of this study confirmed the speedy effect granisetron on nausea induced by cancer chemotherapy including CDDP, but it stopped short of demonstrating sufficient efficacy for vomiting. Prophylactic use, therefore, seems more desirable in view of the patient's QOL, when a highly emetogenic anti-tumor drug, such as CDDP, is used.

Adult↗

[Postoperative vomiting after pars plana vitrectomy].

In the present investigation we compared two different techniques of anaesthesia--total intravenous anaesthesia (TIVA) versus balanced anaesthesia--with and without antiemetic prophylaxis, with regard to postoperative nausea, strangling irritation and vomiting and their influence upon postoperative complications (intraocular bleedings) and postoperative intraocular pressure after pars plana vitrectomia. For this investigation four groups were formed. The anaesthesias were carried out as orotracheal intubational anaesthesia following two standard techniques, which only differ in the choice of the narcotics. Half the patients in each group were treated with an antiemetic prophylaxis of 2.5 mg DHBP. With regard to the occurrence of postoperative nausea and vomiting, the TIVA-groups proved to be better than those with balanced anaesthesia (16% to 43.5%; p < 0.05): DHBP in both methods led to a reduction of postoperative vomiting and nausea, but the differences showed not to be significant (p > 0.05). Best results were achieved with a combination of TIVA (propofol, alfentanil, atracurium, air/O2) and DHBP (4.7%). The total rate of postoperative complications in form of intraocular bleedings amounted to 8.6%. The appearance of complications increased when postoperative nausea and vomiting or increased intraocular pressure were observed (16.6% to 6.3%; 21.2% to 6.1%). Intraocular pressure, measured for four hours postoperatively, was significantly lower in the TIVA-groups than in the balanced anaesthesia-groups (15.5 +/- 7.7 mmHg to 18.3 +/- 8.2 mmHg). Therefore, we conclude that TIVA with propofol appears to be especially suitable for intraocular surgery.

Adult↗

[Postoperative nausea, vomiting and pain in laparoscopic cholecystectomy: a comparison with minilaparotomy-cholecystectomy].

Postoperative nausea, vomiting and pain were compared between laparoscopic cholecystectomy group and minilaparotomy-cholecystectomy group. All patients were women, and ranged in age from 20 to 60 years. The body mass index of the patients was less than 30, and duration of operation was within 120 minutes in both groups. All patients received general anesthesia combined with epidural analgesia. Morphine hydrochloride 4 mg was administered into epidural space before incision. No significant differences were found in the incident of nausea and vomiting among the two groups. Postoperative analgesic requirement of laparoscopic cholecystectomy group was significantly less than that of minilaparotomy-cholecystectomy group. No significant differences were found in the incidence of nausea and vomiting between the group which required postoperative analgesic drugs and the group which required no postoperative analgesic drugs. These results suggest that laparoscopic operation and postoperative pain do not influence the incidence of nausea and vomiting. Postoperative pain after laparoscopic cholecystectomy is less than that after minilaparotomy-cholecystectomy.

Adult↗

Guidelines for the optimal management of chemotherapy-induced nausea and vomiting: a consensus.

Nausea and vomiting are the most frequently reported adverse effects of cancer chemotherapy and have a significant impact on patients' daily functioning, quality of life and compliance with chemotherapy. Summarized in this article are the recommendations for the optimal management of nausea and vomiting developed by a multidisciplinary group of health care professionals. Issues relating to chemotherapy-induced nausea and vomiting are discussed; general principles of treatment are reviewed; treatment algorithms based on emetogenicity and types of chemotherapy are presented; and the importance of issues including non-pharmacological approaches, patient education and pharmacoeconomic perspectives are considered. The goal of antiemetic therapy should be no episodes of vomiting or retching and minimal or no nausea. Data from clinical trials support the clear superiority of 5-HT3 receptor antagonists in a variety of clinical situations. Their cost must be considered not only as an isolated item from the institutional perspective, but also from the perspective of the impact of successful therapy on the patient.

Algorithms↗