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.     

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.     

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.     

Double-blind,placebo-controlled,dose-ranging study of ramosetron for the prevention of nausea and vomiting after thyroidectomy

BACKGROUND: Patients receiving general anesthesia during thyroidectomy have a high risk for postoperative nausea and vomiting. OBJECTIVE: This prospective, randomized, double-blind, placebo-controlled, dose-ranging study was undertaken to assess the efficacy and safety of ramosetron, a selective 5-hydroxytryptamine type 3-receptor antagonist, in preventing nausea and vomiting after thyroidectomy. METHODS: Standard general anesthetic technique and postoperative analgesia were employed. Patients undergoing thyroidectomy were randomized to receive IV ramosetron 0.15, 0.3, or 0.6 mg or placebo at completion of the procedure. During the first 48 hours after anesthesia, episodes of emesis and adverse events were assessed by nursing staff who were blinded to patients' treatment assignment. RESULTS: Eighty patients (22 men, 58 women; age range, 28-63 years; weight range, 37-91 kg) were enrolled in the study. There were no differences in demographic characteristics between treatment groups. The numbers of patients who were emesis free (no nausea, retching, or vomiting) 0 to 24 hours after anesthesia were 10 of 20 (50%) with ramosetron 0.15 mg, 17 of 20 (85%) with ramosetron 0.3 mg, 18 of 20 (90%) with ramosetron 0.6 mg, and 8 of 20 (40%) with placebo. The corresponding numbers 24 to 48 hours after anesthesia were 11 of 20 (55%), 18 of 20 (90%), 18 of 20 (90%), and 9 of 20 (45%). At both time points, only the values for ramosetron 0.3 and 0.6 mg were statistically significant versus placebo (P < or = 0.001). No clinically serious adverse events were observed in any group. CONCLUSIONS: In this population of patients receiving general anesthesia while undergoing thyroidectomy, ramosetron 0.3 mg was effective in preventing postoperative nausea and vomiting 0 to 48 hours after anesthesia. Increasing the dose to 0.6 mg provided no demonstrable benefit.     

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.     

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.     

Treatment of postoperative emetic symptoms with granisetron in women undergoing abdominal hysterectomy: a randomized, double-blind, placebo-controlled, dose-ranging study

Background

Postoperative emetic symptoms (nausea, retching, and vomiting) frequently occur in women undergoing general anesthesia for abdominal hysterectomy. In a previous report by us, granisetron, a selective serotonin receptor antagonist, was more effective than the traditional antiemetics, droperidol and metoclopramide, for the treatment of postoperative emetic symptoms in this population.

Objective

The aim of this study was to determine the optimal dose of granisetron for the treatment of emetic symptoms following abdominal hysterectomy.

Methods

This randomized, double-blind, placebo-controlled, dose-ranging study was conducted at Toride Kyodo General Hospital (Toride, Japan). Female patients aged 33 to 66 years experiencing postoperative emetic symptoms after abdominal hysterectomy were eligible for the study. Patients received IV granisetron at 1 of 4 doses (10, 20, 40, or 100 μg/kg) or placebo; they were then observed for 24 hours. Emetic symptoms and the need for a rescue antiemetic were recorded by nursing staff, who were blinded to treatment assignment.

Results

A total of 100 patients (mean [SD] age, 45 [7] years [range, 33-66 years]) were enrolled (n = 20 in each group). No significant differences in patient demographic characteristics were observed between the groups. The number of patients in whom complete control of postoperative emetic symptoms, defined as being free of emetic symptoms and not needing rescue antiemetic medication for 24 hours after study drug administration, was established was significantly greater in 3 of the granisetron groups than in the placebo group (6 patients [30%]): granisetron 10 μg/kg, 7 patients (35%; P= NS); granisetron 20 μg/kg, 17 patients (85%; P = 0.001); granisetron 40 μg/kg, 17 patients (85%; P = 0.001); and granisetron 100 μg/kg, 16 patients (80%; P = 0.002). No clinically significant adverse events attributable to the study drug were observed in any group.

Conclusion

In this study of patients who experienced emetic symptoms after undergoing general anesthesia for abdominal hysterectomy, granisetron at doses ≥20 μg/kg was effective in the treatment of established postoperative emetic symptoms.     

Effects of granisetron in the treatment of nausea and vomiting after laparoscopic cholecystectomy: a dose-ranging study

BACKGROUND: Patients undergoing general anesthesia for laparoscopic cholecystectomy are at high risk for postoperative emetic symptoms (nausea, vomiting, and retching). Antihistamines, butyrophenones, dopamine receptor antagonists, and selective serotonin receptor antagonists (SSRAs) have been investigated for the prevention and treatment of emetic symptoms. However, these drugs are associated with undesirable adverse effects (AEs), such as excessive sedation, hypotension, dry mouth, dysphoria, hallucinations, and extrapyramidal signs. Granisetron hydrochloride is a newer SSRA developed for the prevention and treatment of cytotoxic drug-induced emetic symptoms, but its effects in postoperative laparoscopic cholecystectomy have not been studied. OBJECTIVE: The aims of this study were to assess the efficacy and tolerability of 4 doses of granisetron, and to determine the minimum effective dose, for the control of established emetic symptoms in patients undergoing general anesthesia for laparoscopic cholecystectomy. METHODS: This prospective, randomized, double-blind, placebo-controlled, dose-ranging study was conducted in the Departments of Anesthesiology and Surgery, Toride Kyodo General Hospital (Toride, Japan). Male and female patients aged 23 to 68 years with American Society of Anesthesiologists physical status I (no organic, physiologic, biochemical, or psychiatric disturbance) who were experiencing nausea lasting >10 minutes or retching or vomiting within 3 hours after recovery from general anesthesia for laparoscopic cholecystectomy were enrolled. Patients were randomized to receive a single IV dose of placebo or granisetron at 1 of 4 doses (10, 20, 40, or 80 microg/kg). Patients were monitored for 24 hours after study drug administration. RESULTS: One hundred patients (60 women, 40 men; mean [SD] age, 48 [10] years [range, 23-68 years]; mean [SD] height, 158 [7] cm [range, 145-177 cm]; mean [SD] body weight, 56 [8] kg [range, 43-75 kg]) were enrolled. No significant differences in baseline demographic or clinical characteristics were found between the study groups. The proportions of patients who were free of emetic symptoms were significantly higher with granisetron 20, 40, and 80 microg/kg than with placebo (P = 0.02, 0.007, and 0.007, respectively). The difference between the granisetron 10-microg/kg group and the placebo group was not significant. No clinically significant AEs were reported in any group. CONCLUSIONS: Granisetron 20 microg/kg was the minimum effective dose for the treatment of established postoperative emetic symptoms in patients undergoing laparoscopic cholecystectomy. Increasing the dose to 80 microg/kg provided no further benefit.     

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.     

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.     

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.     

超声引导下连续股神经阻滞联合喉罩下全麻与硬膜外阻滞复合喉罩下全麻用于全膝关节置换术的效果比较

目的 比较超声引导下连续股神经阻滞联合喉罩全麻与连续硬膜外阻滞复合喉罩全麻用于全膝关节置换术的效果.方法 择期行全膝关节置换术的类风湿性关节炎和骨关节炎造成的膝关节破坏患者60例,采用随机数字表法分为2组.Ⅰ组超声引导行连续股神经阻滞联合喉罩下全麻,Ⅱ组在连续硬膜外阻滞复合喉罩下全麻.记录术中和PACU停留期间的生命体征用药情况.记录术后48 h内PAC药物用量和恶心呕吐、低血压的发生情况,术后VAS评分和患者总体满意度评价.结果 2组一般资料比较无显著差异（P＞0.05）,2组患者术后6h、12 h、24 h、48 hVAS评分比较无显著差异（P＞0.05）.Ⅰ组术中截骨后即刻平均动脉压、心率与Ⅱ组比较有显著差异（P＜0.05）,其他效果基本一致,Ⅱ组术后恶心呕吐,低血压发生率比Ⅰ组高（P＜0.05）.结论 两种方式均能满足术后镇痛需要,但Ⅰ组并发症少、风险低,操作简单直观,患者舒适度高.     

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.     

Comparison of granisetron with granisetron plus droperidol combination prophylaxis in post-operative nausea and vomiting after laparoscopic cholecystectomy

The aim of this study was to evaluate the effects of granisetron and granisetron plus droperidol combination therapy on post-operative nausea and vomiting (PONV) in 60 patients who had undergone elective laparoscopic cholecystectomy. Induction of anaesthesia was achieved using 5 mg/kg thiopentone, 2 micrograms/kg fentanyl and 0.5 mg/kg atracurium, and anaesthesia was maintained with 2-2.5% sevoflurane. The patients were randomly assigned to two groups: group G (granisetron) (n = 30) patients received 3 mg granisetron and group GD (granisetron plus droperidol) (n = 30) patients received 3 mg granisetron and 1.25 mg droperidol shortly before the induction of anaesthesia. PONV incidence was recorded post-operatively at 15 min, 30 min, 60 min, 2 h, 4 h, 12 h and 24 h. While PONV prophylaxis provided almost complete emetic control in patients who received the granisetron plus droperidol combination, patients who received granisetron prophylaxis alone experienced PONV more frequently at 30 min and 60 min post-operatively. We conclude that addition of a low dose of droperidol to granisetron prophylaxis is more effective than granisetron prophylaxis alone for successful control of PONV.     

Control of emsis by intravenous granisetron in breast cancer patients treated with 5-FU,epirubicin and cyclophosphamide

Granisetron, a potent and selective 5-hydroxytryptamine receptor (5-HT₃) antagonist was reported to be an effective antiemetic agent both in animal studies and in patients given highly emetogenic chemotherapy. A sample of 43 patients with breast cancer was accrued from September to November 1992 in a phase II study to assess the efficacy of granisetron in patients receiving FEC (5-FU, epirubicin, cyclophosphamide). Each patient received 3 mg intravenous granisetron as a single dose just prior to chemotherapy. Oral metoclopromide was prescribed to each patient as a rescue anti-emetic. The emetic episodes and degree of nausea were evaluated on a daily basis. Good control of emesis (0–2 episodes of vomiting) and nausea (mild or no nausea) was in the range 77%–98% and 77%–93% respectively. There was a complete response (no emetic episodes throughout the 6-day period) in 16 patients (37.2%). Onset of emesis tends to occur on day 1 and tend to subside after day 3; 85% of patients had onset of emesis in the first 2 days after chemotherapy. Control of emesis and nausea tends to improve after day 3, which could be the result of the reduced emetogenicity of the combination FEC with time. Altogether, 77% had good control of acute emesis; control of delayed emesis was better with 84% achieving a major response on day 2 after chemotherapy, which improved to more than 90% after day 4. Granisetron was generally tolerated with headache being the most common side-effect folloed by constipation and flushing. This study suggests that granisetron is an effective and well-tolerated anti-emetic agent, which deserves randomised trials to elucidate its efficacy further.     

The effectiveness of inhalation isopropyl alcohol vs. granisetron for the prevention of postoperative nausea and vomiting

We evaluated preemptive treatment for postoperative nausea and vomiting (PONV) with intravenous (IV) granisetron, 0.1 mg, introoperatively as compared with the use of 70% inhalation isopropyl alcohol and a control group for the prevention of PONV. We randomly assigned 57 women, 18 to 50 years old, undergoing laparoscopic procedures to 1 of 3 groups: (1) inhalation of 70% isopropyl alcohol, (2) 0.1 mg granisetron IV, and (3) no prophylactic treatment control. Participants were asked to rate their nausea and vomiting preoperatively, on arrival to postanesthesia care unit (PACU), at discharge from PACU, 6 hours after extubation, and 24 hours after extubation and any occurrence of nausea and vomiting using the numeric rating scale (NRS), 0 to 10. Group 1 experienced more PONV episodes than groups 2 and 3 during the 6- to 24-hour postsurgical timeframe (P = .02). There were no significant differences among the 3 groups in demographics, first episode of PONV, total number of episodes in 24 hours, NRS rating at rescue, and anesthetic duration. PONV and menstrual cycle phase had no positive correlation (P > .05). History of smoking, PONV, and motion sickness had no significant difference against any measure of PONV (P > .05).     

Ramosetron for the prevention of cisplatin-induced acute emesis: a prospective randomized comparison with granisetron

Control of nausea and vomiting is very important in determining patient compliance with cisplatin chemotherapy. A multicentre, randomized, single-blind study was conducted to compare the tolerability and efficacy of ramosetron with those of granisetron over 24 h following cisplatin administration to cancer patients. In eight study centres, a total of 194 adult patients were randomly assigned to receive either intravenous ramosetron 0.3 mg or intravenous granisetron 3.0 mg. The anti-emetic effect of ramosetron determined from the no-vomiting rate lasted longer, but there was no significant difference in the number of acute vomiting episodes or the severity of nausea between the two groups. In the tolerability evaluation, there were no statistically significant differences between the two groups, except for a higher incidence of dull headache in the granisetron group. Ramosetron and granisetron appear to have equivalent efficacy and tolerability profiles, but the effects of ramosetron on the prevention of acute vomiting in patients undergoing cisplatin chemotherapy were longer lasting.     

Effects of Ondansetron and Granisetron on Postoperative Nausea and Vomiting in Adult Patients Undergoing Laparoscopic Cholecystectomy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Background: Postoperative nausea and vomiting (PONV) are common and potentially distressing adverse events (AEs) associated with surgery and anesthesia. In patients undergoing laparoscopic cholecystectomy (LC) without antiemetic prophylaxis, the incidence of PONV can be as high as 72%.Objective: The aim of this study was to investigate the prophylactic antiemetic effects of ondansetron and granisetron in patients undergoing LC when these agents are administered before the end of surgery.Methods: Patients classified by the American Society of Anesthesiologist's physical status as I or II who were scheduled for elective LC were included in this randomized, double-blind, placebo-controlled study. Anesthesia was induced with thiopental 5 mg/kg and fentanyl 2 μg/kg, and was maintained with isoflurane 1% to 3% in 50% oxygen and 50% nitrous oxide and fentanyl as needed. Approximately 20 to 30 minutes before the end of the surgery, the patients randomly received either IV ondansetron 100 μg/kg (group O), IV granisetron 40 μg/kg (group G), or normal saline (group P). Plasma levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were determined preoperatively and 24 hours postoperatively. The patients were observed for 24 hours for PONV and other possible AEs. Postoperative pain intensity was determined using a 10-cm visual analogue scale. Four-point satisfaction scores were determined at 24 hours.Results: Ninety patients (69 women, 21 men) participated in the study. Demographic characteristics and operative data (duration of surgery and anesthesia and amount of intraoperative fentanyl) were similar in the 3 groups. The only AE reported by patients during the 24-hour observation period was nonsevere headache. The number of patients experiencing headache was similar in group P, group O, and group G (10 [33%] patients, 6 [20%], and 10 [33%], respectively). No significant changes were found in presurgical and postsurgical plasma levels of ALT and AST in any group. The mean (SD) satisfaction scores in group O and group G (3.0 [0.4] and 3.0 [0.6], respectively) were significantly higher than those in group P (2.5 [0.5]; both, P < 0.01). Immediately after surgery (period 0), significantly more patients in the placebo group (21 [70%]) experienced PONV compared with those in the ondansetron group (9 [30%]; P < 0.05) and the granisetron group (7 [23%]; P < 0.01). During the 24-hour observation period, a significantly greater number of patients in group P (18 [60%]) required a single dose of a rescue antiemetic drug compared with those in groups O and G (9 [30%] and 6 [20%], respectively; both, P < 0.01).Conclusions: Patients administered ondansetron 100 μg/kg or granisetron 40 μg/kg 20 to 30 minutes before the end of LC had significantly higher PONV control during the 24-hour postoperative observation period than patients receiving placebo. However, there were no significant differences between the active treatment groups in the incidence of PONV, patient satisfaction, or AEs.     

快速康复理论在小儿全身麻醉术后早期进饮食中的应用

目的应用快速康复理论探讨婴幼儿及儿童全身麻醉下行非胃肠道择期手术后早期进饮食的安全性及可行性。方法选择240例骨科择期手术患儿,按随机数字表法分为观察组与对照组各120例。观察组患儿术后麻醉清醒、意识清楚后实施早期饮食指导,即无胃肠道和咽喉部不适,有进饮食需求,先少量饮水,无呛咳、恶心、呕吐再进食。对照组按常规术毕4h进饮食。分别于术后2h和进食后1h评估患儿口渴、饥饿、恶心、呕吐、呛咳、疼痛等情况,并进行比较。结果两组患儿术后麻醉清醒及意识清楚时间比较,差异无统计学意义（P〉0.05）。观察组有90.0％的患儿术后2h内饮水,77.5％的患儿术后2h内进食。术后2h观察组患儿口渴、饥饿感的发生率分别为10.8%和22.5%,明显低于对照组的95.0%和99.2%,差异有统计学意义（χ2值分别为66.5,47.0;P〈0.01）,观察组术后2h疼痛评分为（4.73±0.13）分,低于对照组（5.70±0.13）分,差异有统计学意义（t=1.86,P〈0.05）。观察组与对照组患儿术后2h和进食后1h恶心、呕吐和呛咳发生情况比较,差异无统计学意义（P〉0.05）。结论小儿骨科全身麻醉手术患儿术后4h进食的常规可修改,评估患儿术后麻醉清醒、意识清楚后,根据患儿需求术后早进饮食是可行的。