Comparison of granisetron and ramosetron for the prevention of nausea and vomiting after thyroidectomy

BACKGROUND: Postoperative nausea and vomiting (PONV) are common after thyroidectomy. Granisetron, a selective 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist, is more effective than the traditional antiemetics droperidol and metoclopramide for the prevention of PONV after thyroidectomy. Ramosetron, another new selective antagonist of 5-HT3 receptor, has been shown to have more potent and longer-acting properties than granisetron against cisplatin-induced emesis in ferrets. OBJECTIVE: This study was undertaken to compare the efficacy and tolerability of granisetron and ramosetron for the prevention of PONV after thyroidectomy. METHODS: In this randomized, double-blind study, patients received granisetron 3 mg or ramosetron 0.3 mg intravenously at the end of surgery. A standard general anesthetic technique and postoperative analgesia were used. Emetic episodes and safety were assessed during the first 24 hours and the second 24 hours after anesthesia. RESULTS: Eighty patients (15 men, 65 women) aged 33 to 58 years were included in the study. Each study group consisted of 40 patients. There were no differences between groups with regard to patient demographics. The percentage of patients who were emesis free (no nausea, no retching, no vomiting) 0 to 24 hours after anesthesia was 83% (33 of 40) with granisetron and 88% (35 of 40) with ramosetron; the corresponding rates 24 to 48 hours after anesthesia were 63% (25 of 40) and 90% (36 of 40), respectively (P = 0.004). The safety profile of the two 5-HT3 receptor antagonists was comparable, as no clinically serious adverse effects caused by the study drug were observed in either of the groups. CONCLUSIONS: Prophylactic antiemetic therapy with ramosetron was comparable to therapy with granisetron for the prevention of PONV 0 to 24 hours after anesthesia in patients who underwent thyroidectomy; 24 to 48 hours after anesthesia, ramosetron was more ef- fective than granisetron for prophylaxis against PONV in this population.     

Benefits and risks of granisetron versus ramosetron for nausea and vomiting after breast surgery: a randomized, double-blinded, placebo-controlled trial

Women undergoing general anesthesia for breast surgery are at particular risk of postoperative nausea and vomiting. In a randomized, double-blinded, placebo-controlled trial, 90 patients scheduled for breast surgery, aged 33-63 years, received intravenously placebo, 3 mg granisetron, or 0.3 mg ramosetron (n = 30 of each) at the end of surgical procedure. A standard general anesthetic technique and postoperative analgesia were used. Emetic episodes and safety assessment were performed during 0-24 hours and 24-48 hours after anesthesia. The rate of patients experiencing emetic symptoms (nausea, retching, vomiting) 0-24 hours after anesthesia was 17% with granisetron (P = 0.013) and 10% with ramosetron (P = 0.002) compared with placebo (47%); the corresponding rate 24-48 hours after anesthesia was 27% (P = 0.032) and 7% (P = 0.001), compared with placebo (53%). In the 24-48 hours after anesthesia, there were fewer emetic episodes in patients who had received ramosetron than in those who had received granisetron (P = 0.039). The severity of nausea was less in patients receiving ramosetron than in those receiving granisetron (P = 0.044). Zero to 24 hours after anesthesia, no difference in the rate of patients having emetic symptoms and the severity of nausea was observed between the granisetron and ramosetron groups. The most common reported adverse events were headache and dizziness, and there were no difference in the incidence of adverse events due to the study drug among the 3 groups. In conclusion, prophylactic therapy with ramosetron is more effective than that with granisetron for the long-term prevention of postoperative nausea and vomiting in women undergoing general anesthesia for breast surgery.     

Randomized, double-blind, placebo-controlled, dosed-finding study of the antiemetic effects and tolerability of ramosetron in adults undergoing middle ear surgery

BACKGROUND: Ramosetron is a selective serotonin receptor antagonist (SSRA) that is approved for the treatment of emetic symptoms induced by cytotoxic drugs in Japan. We have reported that ramosetron 0.3 mg had comparable efficacy to granisetron 3 mg, another SSRA, in preventing emetic symptoms in adults in the first 48 hours after the start of anesthesia for middle ear surgery. Although it has been shown that a high dose of ramosetron can cause adverse effects (AEs), such as severe headache, the minimal effective dose of ramosetron is unknown. OBJECTIVE: The aim of this study was to determine the minimum effective and tolerable dose of ramosetron needed to prevent postoperative emetic symptoms in adult patients undergoing middle ear surgery. METHODS: This randomized, double-blind, placebo-controlled, dose-finding study was conducted at the Department of Anesthesiology, Toride Kyodo General Hospital (Toride, Japan). Patients aged > or =20 years scheduled for middle ear surgery were randomized to receive either placebo or ramosetron at 1 of 3 doses (0.15, 0.3, or 0.6 mg), regardless of body weight, i.v. immediately before anesthesia induction. Emetic symptoms (nausea, retching, or vomiting) occurring from 0 to <24 and 24 to 48 hours after the start of anesthesia were recorded. Other AEs also were assessed. RESULTS: A total of 100 patients (55 women, 45 men; mean [SD] age, 44 [12] years; mean [SD] body weight, 56 [8] kg; mean [SD] height, 159 [8] cm) were enrolled. Each treatment group comprised 25 patients. The treatment groups were comparable with regard to demographic characteristics and type of surgery After the second 24 hour postanesthesia period, significantly more patients in the ramosetron 0.3-mg and 0.6-mg groups were emesis free than in the placebo group (both P<0.001). The number of emesis-free patients in the ramosetron 0.15-mg group and the placebo group were similar after both study periods. No significant difference in antiemetic efficacy was found between the ramosetron 0.3-mg and 0.6-mg groups. No relationship between body weight and the efficacy of ramosetron was observed. The incidence of AEs was similar in all 4 groups. CONCLUSIONS: Ramosetron 0.3 mg, regardless of body weight, was more effective than either ramosetron 0.15 mg or placebo and as effective as ramosetron 0.6 mg for the prevention of emetic symptoms in the first 48 hours after the start of anesthesia in this selected population of adult patients who underwent middle ear surgery.     

Results of a prospective, randomized, double-blind, placebo-controlled, dose-ranging trial to determine the effective dose of ramosetron for the prevention of vomiting after tonsillectomy in children

BACKGROUND: Postoperative vomiting (POV) is an important adverse effect of anesthesia and surgery, and children undergoing tonsillectomy may be particularly at risk. OBJECTIVE: The aim of this study was to determine the effective dose of ramosetron, a 5-hydroxytryptamine type 3 receptor antagonist, for prophylaxis of severe POV (> or =2 episodes) in children undergoing general anesthesia for tonsillectomy. METHODS: Standard general anesthetic technique and postoperative analgesia were used in this prospective, randomized, double-blind, placebo-controlled, dose-ranging trial of pediatric patients. Patients who had experienced POV, had taken an antiemetic medication within 24 hours before surgery of had a history of motion sickness were excluded. Only patients aged 4 to 10 years were included, because of their ability to answer questions. Patients received a single administration of either i.v. placebo or i.v. ramosetron at 3, 6, or 12 microg/kg immediately after the end of surgery. During the first 48 hours after anesthesia, episodes of retching, vomiting, and adverse events were recorded by nursing staff blinded to treatment assignment. RESULTS: Eighty children (20 in each group)--42 girls and 38 boys--were enrolled. There were no differences in patient demographic characteristics among the treatment groups. The rates of complete response (no vomiting, retching, or need for another antiemetic medication) from 0 to 24 hours after anesthesia were 35% (7/20) with ramosetron 3 microg/kg, 90% (18/20) with ramosetron 6 micro/kg, and 90% (18/20) with ramosetron 12 microg/kg compared with placebo (30% [620], P=NS, P=0.001, and P=0.001 vs placebo, respectively); the corresponding rates from 24 to 48 hours after anesthesia were 35% (7/20), 90% (18/20), and 95% (19/20) compared with placebo (35% [7/20]; P=NS, P=0.001, and P=0.001 vs placebo, respectively). No difference in antiemetic efficacy was observed between ramosetron 6 and 12 microg/kg. No clinically serious adverse events attributable to the study drug were observed in any group. CONCLUSIONS: In the pediatric population studied, ramosetron 6 microg/kg was effective for the prevention of vomiting after tonsillectomy from 0 to 48 hours after anesthesia. Increasing the dose to 12 microg/kg did not appear to provide further benefit.     

Comparison of ramosetron, dexamethasone, and a combination of ramosetron and dexamethasone for the prevention of postoperative nausea and vomiting in Korean women undergoing thyroidectomy: A double-blind, randomized, controlled study

Background: Thyroidectomy is associated with a relatively high incidence of postoperative nausea and vomiting (PONV), ranging from 51% to 76%. Because these symptoms are distressing for patients, prophylactic medication to avoid or reduce PONV is recommended.Objective: The aim of the present study was to compare the efficacy of ramosetron, dexamethasone, and a combination of ramosetron and dexamethasone in preventing PONV in Korean women undergoing thyroidectomy.Methods: In this double-blind, randomized, controlled trial, consecutive adult female patients who were scheduled to undergo thyroidectomy under general anesthesia at the Kyungpook National University Hospital (Daegu, Korea) were randomly assigned to receive ramosetron 0.3 mg alone, dexamethasone 8 mg alone, or a combination of ramosetron 0.3 mg and dexamethasone 8 mg administered intravenously as a single dose immediately after induction of anesthesia. The primary end point of this study was the total PONV rate up to 24 hours postanesthesia. The secondary end points were the incidence of nausea, incidence of vomiting, severity of nausea (0 = no nausea to 10 = nausea as bad as it could be), use of rescue antiemetic drugs, and the occurrence of adverse events (AEs) determined through interview or spontaneous patient report for 24 hours postanesthesia.Results: A total of 198 female patients were approached for study inclusion, 18 of whom were excluded. Therefore, 180 Korean women (mean [SD] age, 46.5 [12.6] years; height, 159.8 [2.7] cm; weight, 53.2 [3.6] kg) were enrolled and completed the study. The total PONV rates up to 24 hours postanesthesia were 35%, 13%, and 10% in the dexamethasone, ramosetron, and combination groups, respectively. The PONV rate was significantly lower in the combination group than in the dexamethasone alone group (P = 0.006). The PONV rate was not significantly different in the combination group compared with the ramosetron alone group. The PONV rate in the dexamethasone alone group was significantly higher than that in the ramosetron alone group (P = 0.03). The severity of nausea (median [25th-75th percentiles], 0 [0-0] vs 0 [0-4]; P = 0.009) and rate of use of rescue antiemetic drugs (5% vs 27%; P = 0.006) were significantly lower in the combination group than in the dexamethasone alone group, whereas the severity of nausea (median [25th-75th percentiles], 0 [0-0] vs 0 [0-0]) and rate of use of rescue antiemetic drugs (5% vs 7%) were not significantly different between the combination and ramosetron alone groups. The severity of nausea (median [25th-75th percentiles], 0 [0-4] vs 0 [0-0]; P = 0.033) and the rate of use of rescue antiemetic drugs (27% vs 7%; P = 0.018) were significantly higher in the dexamethasone alone group than in the ramosetron alone group. The rates of AEs (headache: 15%, 20%, and 18%; dizziness: 18%, 22%, and 15%) were not significantly different in the dexamethasone alone, ramosetron alone, or combination groups, respectively.Conclusions: The combination of ramosetron and dexamethasone was more effective in reducing PONV than was dexamethasone monotherapy. However, the combination did not show additional benefits compared with ramosetron alone in preventing PONV after thyroidectomy in these Korean women.     

Clinical evaluation of Ramosetron injections in the treatment of cisplatin-induced nausea and vomiting

A phase III, double-blind, placebo-controlled study was performed to examine the safety and efficacy of ramosetron in cancer patients with cisplatin-induced nausea/vomiting. Patients were divided into two groups: group R received 0.3 mg ramosetron intravenously and group P received placebo. Eighty-eight patients were enrolled, 44 in each group; 84 (43 in group R, 41 in group P) were included in the clinical efficacy analysis and 86 (44 in group R, 42 in group P) in the safety analysis. Ramosetron was significantly more clinically effective than placebo against nausea, vomiting and anorexia; 65.1% of patients in group R experienced no vomiting in the first 6 h of observation compared with 7.3% of those receiving placebo. No serious adverse reactions or significant differences in safety were observed between the groups. Based on these results, ramosetron injection is effective in the treatment of cisplatin-induced nausea/vomiting and its clinical usefulness is demonstrated here.     

Granisetron versus granisetron/dexamethasone combination for the treatment of nausea,retching, and vomiting after major gynecologic surgery: a randomized,double-blind study

BACKGROUND: Granisetron, a selective 5-hydroxytryptamine3 antagonist, is effective for the treatment of patients with postoperative nausea and vomiting. Dexamethasone decreases chemotherapy-induced emesis when added to an antiemetic regimen. OBJECTIVE: This study compared the efficacy of granisetron alone with granisetron/dexamethasone combination for the treatment of nausea and vomiting after major gynecologic surgery. METHODS: In this randomized, double-blind study, patients who were experiencing emetic symptoms during 0 to 3 hours after the end of anesthesia administration received granisetron 40 microg/kg i.v. either alone or in combination with dexamethasone 8 mg. Patients then were observed for 24 hours after study drug administration, with emetic episodes recorded and tolerability assessments performed by nursing staff blinded to treatment. RESULTS: A total of 120 women were enrolled (n = 60 in each treatment group; mean [SD] age in the granisetron group, 44 [9] years [range, 23-63 years]; combination group, 45 [8] years [range, 21-65 years]). No significant differences in patient demographic characteristics were found between the 2 treatment groups. However, the percentage of patients free of emetic symptoms (nausea, retching, vomiting) was higher in the granisetron/dexamethasone combination group than in the granisetron group (95.0% and 80.0%, respectively; P = 0.012). No clinically serious adverse events attributed to the study drugs were observed in either group. CONCLUSION: In this study, the granisetron/dexamethasone combination was more effective than was granisetron alone for the management of nausea and vomiting during 0 to 3 hours after anesthesia in women undergoing major gynecologic surgery.     

Oral formulations of the selective serotonin3 antagonists ramosetron (intraoral disintegrator formulation) and granisetron hydrochloride (standard tablet) in treating acute chemotherapy-induced emesis, nausea, and anorexia: A multicenter, randomized, single-blind, crossover, comparison study

Background: Chemotherapeutic drugs used to treat cancer may cause nausea and emesis by inducing the release of 5-hydroxytryptamine (5-HT) in the small intestine. Blockage of 5-HT₃ receptors in the small intestine by 5-HT₃-receptor antagonists might prevent the nausea and vomiting associated with chemotherapy for cancer.Objective: The aim of this study was to compare the efficacy and tolerability of the selective 5-HT₃ antagonists ramosetron (0.1-mg intraoral disintegrator preparation) and granisetron hydrochloride (2-mg standard tablet) in the treatment of acute chemotherapy-induced digestive disturbances.Methods: Male and female Chinese cancer patients aged 16 to 74 years were eligible for this multicenter, randomized, single-blind, crossover, comparison study. Patients were randomized to 1 of 2 treatment groups. Group 1 received 1-time administration of ramosetron 0.1 mg orally without water, followed by a 2-week washout period after which they received granisetron 2 mg orally with water. Group 2 received granisetron 2 mg orally with water, followed by a 2-week washout period after which they received ramosetron 0.1 mg orally without water. Each study drug was administered 1 time, 1 hour before infusion of the chemotherapeutic agent. For the efficacy assessment, response data were recorded every 6 hours for a total of 24 hours after the start of chemotherapy infusion. For the tolerability assessment, adverse events (AEs) were recorded continuously over 24 hours.Results: A total of 73 patients (46 males, 27 females; mean age, 49.6 years [range, 17-70 years]) were enrolled. Group 1 comprised 37 patients; group 2, 36 patients. Data from 62 (84.9%) patients were used in the efficacy assessment; data from 70 (95.9%) patients were used in the tolerability assessment. The ability of ramosetron to prevent emesis, nausea, and anorexia was similar to that of granisetron during the 0-to-6-hour and 0-to-24-hour periods following administration of cisplatin or doxorubicin chemotherapy. The tolerability of ramosetron was similar to that of granisetron; AEs were generally mild and transient.Conclusions: In this study, both the intraoral disintegrator formulation of ramosetron and the standard tablet formulation of granisetron were clinically useful for preventing chemotherapy-induced digestive disturbances in cancer patients.     

Procedures for preventing postoperative nausea and vomiting after laparoscopic cholecystectomy: dexamethasone and ondansetron

This randomized double-blind study was undertaken to evaluate the efficacy of ondasetron and dexamathesone in reducing the incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy. The study covered 60 patients (ASA I/II) who had undergone laparoscopic cholecystectomy under general anesthesia. The patients were divided into two groups: 1) 30 patients who received dexamethasone, 4 mg i.v.; and 2) 30 patients who took ondansetron, 4 mg i.v., prior to general anesthesia. Postoperatively, nausea, vomiting, and severe pain (VAS) were observed every 6 hours within the first 24 hours. Postoperative nausea and vomiting occurred in 6 (20) patients in Group I and in 13 (43.33) patients in Group 2 (p < 0.05), while vomiting did only in 5 (16.66%) patients in Group I and 4 (13.33%) in Group 2 (p > 0.05). The least intensity of postoperative pain was observed in Group 1, but the difference between the study groups was insignificant. It is concluded that dexamethasone is more effective in preventing postoperative nausea and vomiting after laparoscopic cholecystectomy than ondansetron. This is mainly determined by a significant reduction in the incidence of postoperative nausea.     

Ondansetron is effective in decreasing postoperative nausea and vomiting.

The efficacy of ondansetron, a selective 5-HT3 receptor antagonist, in preventing postoperative nausea and vomiting in surgical patients was studied. Fifty women were randomized in a double-blind manner to receive either two 8 mg doses of intravenous ondansetron or two doses of placebo vehicle: the first given just before general anesthesia induction and the second 8 hours later. During the first 24 postoperative hours, the number of emetic episodes was recorded and the subjects rated their nausea on a scale from 0 to 10. Ondansetron-treated subjects had fewer emetic episodes (p less than 0.001) and lower subjective nausea scores (p less than 0.001). The number of complete responders (no emetic episodes and no rescue therapy) was 1 of 24 (4%) and 15 of 26 (58%) in the placebo and ondansetron groups, respectively (p less than 0.001). Ondansetron is clearly more effective than placebo in the prophylaxis of postoperative nausea and vomiting. The adverse event profile for ondansetron was similar to that of placebo.     

A comparison of granisetron,droperidol, and metoclopramide in the treatment of established nausea and vomiting after breast surgery: a double-blind,randomized, controlled trial

BACKGROUND: Women undergoing breast surgery are at particular risk for post-operative nausea and vomiting (PONV), with an incidence of emesis as high as 50% when no prophylactic antiemetic is used.OBJECTIVE: This study compared the efficacy of the selective 5-hydroxytryptamine(3) receptor antagonist granisetron with that of the traditional antiemetics droperidol and metoclopramide in the treatment of established PONV after breast surgery. METHODS: In this prospective, randomized, double-blind trial, patients who had undergone breast surgery and were experiencing PONV during the first 3 hours after anesthesia received either granisetron 40 microg/kg IV, droperidol 20 microg/kg IV, or metoclopramide 0.2 mg/kg IV. Patients were observed for 24 hours after administration of study drug. Emetic episodes were recorded by nursing staff who were blinded to treatment assignment. RESULTS: Seventy-five patients were enrolled in the study, 25 in each treatment group. Their age ranged from 41 to 65 years. There were no significant between-group differences in patients' demographic or surgical characteristics at study entry. The number of patients who were emesis free (no nausea, retching, or vomiting) was significantly higher in patients who received granisetron (88% [2225]) than in those who received droperidol (64% [1625]; P = 0.047) or metoclopramide (56% [1425]; P = 0.013). In patients who experienced nausea (3, 8, and 9 patients in the granisetron, droperidol, and metoclopramide groups, respectively), the severity of nausea was significantly lower with granisetron compared with droperidol (P = 0.028) and metoclopramide (P = 0.025). No clinically serious adverse events were observed in any group. CONCLUSION: Granisetron was significantly more effective than the traditional antiemetics droperidol and metoclopramide for the treatment of PONV in this population of patients undergoing breast surgery.     

柑橘属和甲氧氯普安在预防神经外科全麻术后恶心呕吐的观察

【摘要】目的 观察柑橘属和甲氧氯普安对预防神经外科全麻术后恶心呕吐的疗效差异。 方法 将2014年206例神经外科全麻术后患者,随机分为柑橘组103例,甲氧氯普安组103例,在术后回病房后3小时内观察期间,针对出现的PONV(恶心呕吐)症状,柑橘组使用自制柑橘属科果皮吸入及氧气雾化方法预防;甲氧氯普安组使用甲氧氯普安10mg肌肉注射方法。 结果 柑橘组和甲氧氯普安组均对神经外科全麻术后恶心呕吐具有明显的抑制作用,差异有统计学意义(P<0.05),而柑橘组和甲氧氯普安组总有效率比较差异无统计学意义(P>0.05),同比情况下柑橘组预防全麻术后恶心呕吐作用整体作用高。 结论 柑橘组对神经外科全麻术后恶心呕吐有明显的抑制作用,且方法操作简便,不存在药物副作用的潜在隐患,减少了患者住院药物费用,为预防全麻术后PONV(恶心呕吐)症状提供了新的方法。 【关键词】神经外科全麻手术;术后恶心呕吐;柑橘属;甲氧氯普安     

Multicenter,randomized trial of ramosetron plus dexamethasone versus ramosetron alone in controlling cisplatin-induced emesis

Goals To establish whether the combination of a corticosteroid (dexamethasone) and the newer serotonin-3 (5-HT₃) receptor antagonist ramosetron is superior to ramosetron alone in controlling cisplatin-induced emesis.Patients and methods A total of 283 patients aged 18–75 years with confirmed malignant disease who were scheduled to receive cisplatin 50 mg/m² with or without other antineoplastic agents were randomized to intravenous treatment with either ramosetron 300 g plus dexamethasone 20 mg (n=149) or ramosetron 300 g alone (n=134) given 30 min prior to cisplatin infusion. If vomiting occurred in the following 24 h, patients in both groups received an intravenous rescue dose of ramosetron 300 g. Subsequently, on days 2 and 3, treatment was continued orally with either ramosetron 100 g once daily plus dexamethasone 8 mg twice daily, or ramosetron 100 g once daily.Main results During the first 24 h after cisplatin infusion, significantly more patients receiving combination therapy had a complete response (no nausea or vomiting or requirement for rescue therapy) than those receiving ramosetron alone (68% vs 54%, respectively; P=0.034), and significantly fewer patients needed a rescue dose of ramosetron (22% vs 34%, respectively; P=0.032). In addition, the percentages of patients with no nausea and no vomiting were significantly greater in the ramosetron plus dexamethasone group than in the ramosetron-alone group at both 24 h and 72 h after cisplatin administration.Conclusions The antiemetic efficacy of ramosetron in cancer patients receiving highly emetogenic cisplatin chemotherapy is significantly enhanced by its use in combination with dexamethasone.This work is presented on behalf of the Philippines Nasea Study Group whose members are listed in the Appendix.     

Biphasic dosing regimen of meclizine for prevention of postoperative nausea and vomiting in a high-risk population

The purpose of this study was to determine if giving 50 mg of meclizine the night before and on the day of surgery would effectively reduce postoperative nausea and vomiting (PONV) for the entire 24 hours after surgery in patients identified as being at high risk for PONV Subjects were randomly assigned to receive either 50 mg of oral meclizine (experimental group) or a placebo (control group) the night before and the day of surgery. All subjects were intravenously administered 4 mg of ondansetron before the conclusion of surgery. Seventy subjects (35 control; 35 experimental) were included in analysis. postoperaIn the placebo group we noted higher verbal numeric rating scale scores for nausea, a higher incidence oftive nausea and vomiting (PONV) continues to be a common complication after general anesthesia, with the incidence ranging from 17% to 87%.15 It has been reported that PONV increased antiemetic requirements, and lower overall anesthesia satisfaction scores at all time intervals measured, compared with the experimental group, but the differences were not statistically significant until analyzed by postoperative setting. No difference in sedation or side effects was noted between groups. Based on these results, we recommend that the administration of 50 mg of oral meclizine the night before and on the day of surgery be considered effective antiemetic prophylaxis in patients identified as having a high risk for PONV.     

The Effect of Ginger on Postoperative Nausea and Vomiting Among Patients Undergoing Upper and Lower Limb Surgery: A Randomized Controlled Trial

PurposePostoperative nausea and vomiting is one of the most common side effects associated with anesthesia. The aim of this study is to determine the effect of ginger on severity and incidence of nausea and vomiting after lower and upper limb surgery.DesignThis was a triple-blinded clinical trial.MethodsSixty eligible patients were randomly assigned to the intervention and control groups. The intervention group received four 250 mg ginger capsules and the control group received four placebo capsules 2 hours before surgery. Incidence and severity of nausea and vomiting immediately after the surgery and 2, 4, 6, and 8 hours after the surgery were evaluated.FindingsThe results of this study showed that the use of ginger capsules significantly reduces the incidence and severity of postoperative nausea and vomiting at different hours after surgery compared to placebo, P < .05, irrespective of the gender and the age of the patients.ConclusionsUse of ginger is effective in decreasing postoperative nausea and vomiting. However, further studies in comorbid patients are required to verify these outcomes.     

A double-blind, crossover, randomized comparison of granisetron and ramosetron for the prevention of acute and delayed cisplatin-induced emesis in patients with gastrointestinal cancer: is patient preference a better primary endpoint?

BACKGROUND: Serotonin receptor antagonists are recommended by the American Society of Clinical Oncology for the prevention of acute and delayed chemotherapy-induced emesis. However, the most effective agent in this class of antiemetic drugs for preventing emesis has not been clearly defined. We therefore performed a double-blind, crossover, randomized, controlled trial comparing the efficacy of granisetron and ramosetron, using patient preference as the primary endpoint. METHODS: Thirty patients receiving two courses of combined chemotherapy (including > or =60 mg/m(2) cisplatin) for gastric or esophageal cancer were randomly assigned to the granisetron-ramosetron group (treatment phase 1: granisetron, 3 mg; treatment phase 2: ramosetron, 0.3 mg) or the ramosetron-granisetron group (treatment phase 1: ramosetron, 0.3 mg; treatment phase 2: granisetron, 3 mg). All patients received methylprednisolone sodium, 250 mg i.v., during each treatment phase. RESULTS: The efficacy of granisetron and ramosetron was similar in terms of the suppression of emesis and appetite status. However, the majority of patients (19/30, 63.3%) expressed a preference for granisetron, as compared with 9 patients (30.0%) who preferred ramosetron; 2 patients (6.7%) had no preference (chi(2) test: p = 0.008; Fisher's exact test: p = 0.015). CONCLUSIONS: (1) A significant proportion of patients prefer granisetron over ramosetron for the prevention of chemotherapy-induced emesis. (2) Granisetron and ramosetron possess similar effectiveness for the suppression of emesis. (3) The variable of 'patient preference' should be accepted as a primary endpoint of antiemetic drug efficacy.     

甲状腺术后患者发生恶心呕吐综合征的影响因素分析

目的探讨甲状腺术后患者发生恶心呕吐综合征(symdrome of postoperative nausea and vomiting,SPNV)影响因素。方法对214例行甲状腺手术患者资料进行回顾性分析,了解患者SPNV发生及影响因素情况。结果术后发生SPNV72例,发生率为33.64%;其中恶心发生率为100.00%,1度、2度、3度分别占47.22%、27.78%、25.00%;呕吐发生率为38.89%,轻度、中度、重度分别占32.14%、57.14%、10.71%;患者不同性别、吸烟史、麻醉方式与手术时间与患者术后发生SPNV具有相关性(均P0.05);多因素分析结果显示,患者为女性、全麻麻醉方式、手术时间≥2 h是引起患者术后发生SPNV的独立危险因素(均P0.05)。结论甲状腺手术患者术后SPNV发生率较高,女性、全麻麻醉方式及手术时间长是引起患者发生SPNV的独立危险因素。     

Rationale for the use of a single fixed intravenous dolasetron dose for the prevention of cisplatin-induced nausea and vomiting

Dolasetron mesilate is a selective 5-HT₃ receptor antagonist that prevents chemotherapy-induced and postoperative nausea and vomiting. For the majority of patients in intravenous dolasetron trials for chemotherapy-induced nausea and vomiting, dosing has been based on body weight (mg/kg). The approved weight-based dose is 1.8 mg/kg based on results of controlled clinical trials. However, trials of dolasetron evaluating oral doses for prevention of chemotherapy-induced emesis, and intravenous doses for prevention and treatment of postoperative emesis have used a fixed milligram dose. To identify an appropriate intravenous fixed milligram dose for the prevention of chemotherapy-induced nausea and vomiting, this analysis was performed to derive efficacy results for fixed milligram doses from pooled results obtained with dosing based on body weight. Intravenous dolasetron doses for 1,598 patients treated on a mg/kg basis (0.3, 0.6, 1.2, 1.8, 2.4, 3.0 and 5.0 mg/kg) in 14 clinical trials were converted to fixed milligram doses based on weight. Fixed-dose groups were established at doses of 50, 75, 100, 125, 150, and 200 mg. Doses less than or equal to the midpoint between two dose groups were included in the lower dose group. Pooled results showed that the 100 mg intravenous dolasetron dose group (who received actual doses of 88–112 mg) produced the highest rate (53%) of complete response (0 emetic episodes and no rescue medication in the 24-h period following initiation of chemotherapy).     

地塞米松对术后硬膜外吗啡引起恶心呕吐的预防作用

目的:评价地塞米松对硬膜外吗啡引起恶心呕吐的预防效果。方法:妇科肿瘤择期手术病人120例,随机双盲分为地塞米松(A)组、恩丹西酮(B)组、生理盐水(C)组三组,每组40人。当手术开始时,随机给予地塞米松10 mg或者恩丹西酮8 mg或者生理盐水2 mL。所有病人在手术结束前1 h均接受硬膜外吗啡2 mg,然后以0.125％布比卡因100 mL和吗啡0.12mg/kg维持硬膜外术后止痛48 h,评价镇痛效果、恶心呕吐。结果:A组和B组早期和晚期恶心呕吐发生率低于C组(P<0.05),而A组和B组无差别(P>0.05)。结论:地塞米松和恩丹西酮均能降低硬膜外吗啡引起的恶心呕吐,地塞米松对术后硬膜外吗啡引起的恶心呕吐有预防作用。