No abstract available.
Gastroparesis* ; Granisetron*

BACKGROUND: Women undergoing general anesthesia for breast mass excision have a high risk for postoperative nausea and vomiting (PONV). We therefore evaluated the efficacy of ramosetron versus granisetron for preventing PONV. METHODS: One hundred twenty women scheduled for breast mass excision received, in a randomized allocated, double-blind manner, an intravenous placebo (P group), granisetron 40microgram/kg (G group) or ramosetron 6 microgram/kg (R group) at the end of surgery. Emetic episode and side effects were assessed. RESULTS: The incidence and severity of nausea in G and R group was less than P group (P<0.05) during the first 24 hrs. The incidence of vomiting in R group was less than P group (P<0.05) during the first 6 hrs. However there was no significant difference in the incidence of PONV between G and R group. CONCLUSIONS: Our results showed that both granisetron and ramosetron significantly decreased the occurrence of PONV compared to placebo. However, any different efficacy for preventing PONV was not revealed between granisetron and ramosetron.
Anesthesia, General* ; Breast* ; Female ; Granisetron* ; Humans ; Incidence ; Nausea ; Postoperative Nausea and Vomiting* ; Vomiting

BACKGROUND: Granisetron, a new 5-HT3 receptor antagonist, was reported as a highly effective antiemetics, especially in combination with dexamethasone, in the prevention of acute emesis induced by cisplatin. But there is lack of data about effectiveness in the prevention of delayed emesis. In this study, the efficacy of granisetron plus dexamethasone in the prevention of delayed emesis induced by cisplatin was evaluated. MATERIALS AND METHODS: Sixty-four patients who were to receive high-dose cisplatin containing chemotherapy regimen were enrolled in this study. They were received 20 mg of dexamethasone and 3 mg of granisetron at 30 min and 10 minutes prior to cisplatin infusion, respectively. They were monitored for 5 days, first 24 hours for acute nausea/ vomiting and the subsequent 4 days for delayed nausea/vomiting. Antiemetic effect of granisetron was evaluated according to the criteria of Italian Group of Antiemetic Research. RESULTS: Control of delayed nausea and vomiting was achieved in 58% and 84%, respectively. Eastern Cooperative Oncology Group performance status was a statistically significant prognostic factor for control of acute vomiting and delayed nausea/vomiting. There were no stastically significant differences between control of delayed nausea/ vomiting and other prognostic factors, including sex, age, and prior history of cisplatin therapy. The antiemetic effect was greater in the patients who had controled acute nausea/ vomiting than those who had not. CONCLUSION: Granisetron plus dexamethasone is an excellent regimen in the control of not only acute emesis but also delayed emesis induced by high-dose cisplatin chemotherapy.
Antiemetics ; Cisplatin ; Dexamethasone* ; Drug Therapy ; Granisetron* ; Humans ; Nausea* ; Receptors, Serotonin, 5-HT3 ; Serotonin ; Vomiting*

PURPOSE: Granisetron is a potent, the most selective 5-HT3 receptor antagonist and is reported to be effective in treatment of radiation-induced emesis. The antiemetic efficacy and safety of oral granisteron was evaluated in patients with receiving highly emetogenic treatment by conventional fractionated irradiation. MATERIAL AND METHODS: Patients with various cancers who were being treated with irradiation were accrued into the present study. The intensity of nausea was evaluated on first 24 hours and on day-7 by patients according to the degree of interference with normal daily life as followings; a) none; b) present but no interference with normal daily life (mild); c) interference with normal daily life (moderate); and d) bedridden because of nausea (severe). Non or mild state was considered to indicate successful treatment. The efficacy of antiemetic treatment was graded as follows; a) complete response; no vomiting, no worse than mild nausea and receive no rescue antiemetic therapy over the 24h period, b) major response; either one episode of vomiting or moderate/severe nausea or had received rescue medication over 24h period, or any combination of these, c) minor response; two to four episodes of vomiting over the 24h period, regardless of nausea and rescue medication, d) failure; more than four medication. The score of the most sympto m was recorded and the total score over 24 hours was summarized. The complete or major response was considered to indicate successful treatment. RESULTS: A total of 10 patients were enrolled into this study, and all were assessable for efficacy analysis. Total nausea control was achieved in 90% (9/10:none=60% plus mild=30%) of total patients after 7 days. The cotrol of vomiting by granisteron was noted in seven patients (70%) of complete response and three (30%) of major response with a hundred-percent successful treatment over 7 days. The minor response or treatment failure were not observed. No significant adverse events or toxicities from granisetron were recorded in patient receiving granisetron. CONCLUSION: We concluded that granisetron is a highly effective antiemetic agent in controlling radiotherapy-induced nausea or vomiting with a minimal toxicity profile.
Granisetron* ; Humans ; Nausea* ; Radiotherapy ; Receptors, Serotonin, 5-HT3 ; Treatment Failure ; Vomiting*

BACKGROUND: Postoperative nausea and vomiting (PONV) remains a challenge for patients and health professionals despite various newly developed prophylactic interventions. We reviewed the efficacy and safety of ramosetron in randomized controlled trials (RCTs) for the prevention of PONV. METHODS: We reviewed 18 randomized controlled trials investigating the efficacy and safety of ramosetron in comparison with placebo or any other drugs. Relevant studies were searched in the MEDLINE, SCOPUS, and the Cochrane database libraries. Our end points of concern were prevention of PONV and adverse effects as dichotomous data. RESULTS: The prophylactic effect of 0.3 mg ramosetron was observed in early PON (relative risk, RR: 0.4; 95% CI 0.3-0.6), early POV (RR: 0.3; 95% CI 0.1-0.6), late POV (RR: 0.3; 95% CI 0.1-0.6), but not late PON (RR: 0.7; 95% CI 0.5-1.0). Compared with placebo, the efficacy of 0.3 mg ramosetron in adults and 6 microg/kg in children were consistently beneficial in preventing PONV overall (RR: 0.4; 95% CI: 03-0.6). The effects of 0.3 mg ramosetron and 3 mg granisetron were similar. No serious side effects or adverse events resulted from ramosetron and other active drugs, and incidence was similar to those of the placebo group. CONCLUSIONS: Ramosetron is effective and safe in children and adults without serious adverse effects compared with placebo or other active drugs, as shown in pooled data of RCTs, in terms of the prevention of PONV.
Adult ; Antiemetics ; Benzimidazoles ; Child ; Granisetron ; Health Occupations ; Humans ; Incidence ; Postoperative Nausea and Vomiting

BACKGROUND: Postoperative nausea and vomiting (PONV) is a distressing adverse effect of anesthesia. This study was designed to evaluate antiemetic effects of metoclopramide, ondansetron and granisetron in middle ear surgery. METHODS: We compared the antiemetic activity of prophylactic administration of metoclopramide, ondansetron and granisetron in 103 patients undergoing middle ear surgery (tympanomastoidectomy and tympanoplasty). All Study drugs were given as a short intravenous infusion 30 minutes before the end of anesthesia. The incidence of PONV were assessed by direct questioning of patients at 6, 12, 24 and 48 hr after recovery from anesthesia. RESULTS: For the first 6 hr recovery period after surgery, the percentages of emesis in patients were 46.7%, 16%, 12% and 16% in the control, metoclopramide, ondansetron and granisetron groups respectively. After 6 hr, the percentage of emesis in patients significantly decreased in the control, ondansetron and granisetron groups when compared with the first 6 hr, but in the metoclopramide group there was no changes after 6 hr. CONCLUSIONS: The antiemetic drugs, metoclopramide, ondansetron and granisetron, were all effective in controling PONV in middle ear surgery.
Anesthesia ; Antiemetics* ; Ear, Middle* ; Granisetron* ; Humans ; Incidence ; Infusions, Intravenous ; Metoclopramide* ; Ondansetron* ; Postoperative Nausea and Vomiting ; Vomiting

OBJECTIVETo develop a headspace gas chromatography method for determining dimethyl sulphate residual in granisetron hydrochloride.

METHODSAn Angilent INNOWAX capillary column with nitrogen gas as carrier and FID as detector was applied in this study. Dimethyl sulphate was tested under a constant column temperature.

RESULTDimethyl sulphate had different retention time from other organic solvents such as alcohol,acetoacetate, isopropanol, dichlormethane and chloroform, which might exist in granisetron hydrochloride. The detection limit of dimethyl sulphate;s was 0.0016%.

CONCLUSIONThe method can be used for the determination of dimethyl sulphate residual in granisetron hydrochloride.

Chromatography, Gas ; methods ; Drug Contamination ; prevention & control ; Granisetron ; analysis ; Pharmaceutical Preparations ; analysis ; Sulfuric Acid Esters ; analysis

PURPOSE: The combination of dexamethasone and granisetron provides effective prophylaxis in patients treated with high-dose cisplatin. We performed this study to evaluate the antiemetic effect of granisetron plus dexamethasone for the patients refractory to metoclo- pramide, dexamethasone, lorazepam (MDL) regimen. MATERIALS AND METHODS: From 1996 to 1998, we administered the MDL regimen in patients who received high-dose cisplatin (more than 60 mg/m/day) for the first time. The granisetron plus dexamethasone were administered in the subsequent cycle for the patients refractory to the MDL regimen during the first or the second cycle of chemotherapy. Efficacies of treatment were assessed daily from days 1 to 5. Complete response was defined as the absence of vomiting episodes and major response as 1 or 2 episodes per day. Complete or major responses were considered effective. RESULTS: Twenty patients received granisetron plus dexamethasone therapy. During the first 24 hours, complete and major responses were achieved in 75% and 15% respectively, thus it was effective in 90% of patients. For delayed vomiting (occurring during days 2 through 5), complete and major responses were achieved in 30% and 50% respectively, thus it was effective in 80%. Side effects included hiccups, headache, diarrhea, sedation, dizziness and insomnia, but discontinuation or dose adjustment was not needed. CONCLUSION: The granisetron plus dexamethasone regimen was an effective antiemetic regimen for the patients refractory to the MDL regimen.
Antiemetics* ; Cisplatin ; Dexamethasone* ; Diarrhea ; Dizziness ; Drug Therapy ; Granisetron* ; Headache ; Hiccup ; Humans ; Lorazepam* ; Metoclopramide* ; Sleep Initiation and Maintenance Disorders ; Vomiting

BACKGROUND/AIMS: Serotonin receptor (eg, 5-HT₃) antagonists are used to treat nausea and vomiting from a variety of causes. Granisetron transdermal system (GTS) is an appealing delivery system for patients with gastroparesis. To assess if GTS improves nausea and vomiting and other gastroparesis symptoms in patients with gastroparesis. METHODS: Patients with gastroparesis and symptoms of nausea and vomiting refractory to conventional treatment were treated with GTS. Symptoms of gastroparesis were assessed using a modified Gastroparesis Cardinal Symptom Index (GCSI). Following 2 weeks of treatment, patients were asked to assess their symptoms and indicate their therapeutic response using the Clinical Patient Grading Assessment Scale (CPGAS) reporting if symptoms of nausea and vomiting improved on a scale: 0 = no change to +7 = completely better. RESULTS: Fifty-one patients received GTS by prescription: average age was 40 ± 17 years, 44 female, 11 diabetics, 23 ± 20% retention at 4 hours on gastric emptying scintigraphy. Thirty-nine of the 51 (76%) patients stated improvement with GTS. There was significant improvement in nausea and vomiting as assessed with CPGAS at 2 weeks (2.28 ± 2.53; P < 0.05). Symptoms of nausea and vomiting significantly improved. Other symptoms including postprandial fullness, loss of appetite, upper abdominal pain, and early satiety improved. Side effects reported included redness at the site of the patch in 7 patients, pruritus in 5, and constipation in 5. CONCLUSIONS: GTS was moderately effective in reducing nausea and/or vomiting in 76% of gastroparesis patients. In addition to nausea and vomiting, symptoms of postprandial fullness, loss of appetite, upper abdominal pain, and early satiety also improved.
Abdominal Pain ; Appetite ; Constipation ; Female ; Gastric Emptying ; Gastroparesis* ; Granisetron* ; Humans ; Nausea ; Prescriptions* ; Pruritus ; Radionuclide Imaging ; Serotonin ; Vomiting

PURPOSE: The physiologic mechanism of chemotherapy induced emesis is poorly understood, but recently it is thought to be mediated by serotonergic (5-hydroxytryptamine-3 or 5-HT3) receptars. 5-HT3 is released by enterochromaffin cells in the gastrointestinal tract, which peaks 2-6 hours after the start of chemotherapy. In this study, the granisetron, an antiemetic agent, was given over 2-hour from the start of cisplatin administration to synchronize the peak level of the drug with that of 5-HT3 release. MATERIALS AND METHODS: Chemotherapy-naive patients undergoing their first cycle of cisplatin ( > 60 mg/m)-based chemotherapy were included. One milligram of granisetron was given intravenously 15 minutes before the start of cisplatin as a loading dose, then 2 mg was given over 2-hour starting with the cisplatin. RESULTS: 24 of 25 patients were evaluable for efficacy and safety. Fifteen (62.5%) of the 24 evaluable patients had advanced gastric carcinoma and 21 (87.5%) received FP (5-FU/ Cisplatin) combination chemotherapy. The complete response rate for acute and delayed vomiting/retching was 58.3% (10/24) and 33.3% (8/24), respectively. The median latency time to first vomiting or retching was 20.3 hours. Side effects were tolerable, but central nervous symptoms (dizziness, headache, or anxiety) and diarrhea were frequently noted. CONCLUSION: Two-hour infusion of granisetron with the beginning of cisplatin showed no superior efficacy compared with historical controls that used bolus administration of granisetron, but somewhat more frequent central nervous system and gastrointestinal symptoms were observed.
Central Nervous System ; Cisplatin* ; Diarrhea ; Drug Therapy ; Drug Therapy, Combination ; Enterochromaffin Cells ; Gastrointestinal Tract ; Granisetron* ; Headache ; Humans ; Vomiting