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.     

Comparison of recovery characteristics, postoperative nausea and vomiting, and gastrointestinal motility with total intravenous anesthesia with propofol versus inhalation anesthesia with desflurane for laparoscopic cholecystectomy: A randomized controlled study

Background:Clinical effects, recovery characteristics, and costs of total intravenous anesthesia with different inhalational anesthetics have been investigated and compared; however, there are no reported clinical studies focusing on the effects of anesthesia with propofol and desflurane in patients undergoing laparoscopic cholecystectomy.Objective: The aim of this study was to determine the effects of total intravenous anesthesia with propofol and alfentanil compared with those of desflurane and alfentanil on recovery characteristics, postoperative nausea and vomiting (PONV), duration of hospitalization, and gastrointestinal motility.Methods: Patients classified as American Society of Anesthesiologists physical status I or II undergoing elective laparoscopic cholecystectomy due to benign gallbladder disease were enrolled in the study. Patients were randomly assigned at a 1:1 ratio to receive total intravenous anesthesia with propofol (2-2.5 mg/kg) and alfentanil (20 μg/kg) or desflurane (4%-6%) and alfentanil (20 μg/kg). Perioperative management during premedication, intraoperative analgesia, relaxation, ventilation, and postoperative analgesia were carried out identically in the 2 groups. Extubation time, recovery time, PONV, postoperative antiemetic requirement, time to gastrointestinal motility and flatus, duration of hospitalization, and adverse effects were recorded. Postoperative pain was assessed using a visual analogue scale.Results: Sixty-eight patients were assessed for inclusion in the study; 5 were excluded because they chose open surgery and 3 did not complete the study because they left the hospital. Sixty patients (33 women, 27 men) completed the study. Recovery time was significantly shorter in the propofol group (n = 30) compared with the desflurane group (n = 30) (8.0 [0.77] vs 9.2 [0.66] min, respectively; P < 0.005). Fifteen patients (50.0%) in the propofol group and 20 patients (66.7%) in the desflurane group experienced nausea during the first 24 hours after surgery. The difference was not considered significant. In the propofol group, significantly fewer patients had vomiting episodes compared with those in the desflurane group (2 [6.7%] vs 16 [53.3%]; P < 0.005). Significantly fewer patients in the propofol group required analgesic medication in the first 24 hours after surgery compared with those in the desflurane group (10 [33.3%] vs 15 [50.0%]; P < 0.005). Patients in the propofol group experienced bowel movements in a significantly shorter period of time compared with patients in the desflurane group (8.30 [1.67] vs 9.76 [1.88] hours; P = 0.02). The mean time to flatus occurred significantly sooner after surgery in the propofol group than in the desflurane group (8.70 [1.79] vs 9.46 [2.09] hours; P = 0.01). The duration of hospitalization after surgery was significantly shorter in the propofol group than in the desflurane group (40.60 [3.49] vs 43.60 [3.56] hours; P = 0.03).Conclusion: Total intravenous anesthesia with propofol and alfentanil was associated with a significantly reduced rate of PONV and analgesic consumption, shortened recovery time and duration of hospitalization, accelerated onset of bowel movements, and increased patient satisfaction compared with desflurane and alfentanil in these patients undergoing laparoscopic surgery who completed the study.     

托烷司琼与氟哌利多复合地塞米松对腹腔镜胆囊切除术后恶心呕吐的对比

目的比较托烷司琼、氟哌利多复合地塞米松预防腹腔镜胆囊切除术后恶心、呕吐的效果。方法择期腹腔镜胆囊切除术患者120例（ASAⅠ～Ⅱ级）,于麻醉前随机分为三组,每组40例。A组：托烷司琼2 mg（加盐水稀释至3 ml）;B组：氟哌利多2.5 mg＋地塞米松10 mg（共3 ml）;C组：生理盐水3 ml。观察术后24 h恶心、呕吐发生率并对两组进行对比。结果三组术后24 h恶心、呕吐总发生率分别为：A组25%,B组30%,C组75%。A组和B组术后恶心、呕吐的发生率均明显低于C组（P〈0.01）,而A组与B组间比较差异无统计学意义（P〉0.05）。结论托烷司琼、氟哌利多复合地塞米松对腹腔镜胆囊切除术后恶心、呕吐都有较好的预防作用,但托烷司琼价格昂贵,相比而言氟哌利多复合地塞米松更显示其性价比优越性。     

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.     

A randomized, double-blind comparison of granisetron alone and combined with dexamethasone for post-laparoscopic cholecystectomy emetic symptoms

Background

Granisetron hydrochloride, a selective serotonin receptor antagonist, has been used to treat established postoperative nausea and vomiting (PONV). Dexamethasone has been shown to reduce the incidence of chemotherapy-induced emesis when added to an antiemetic regimen.

Objective

The aim of this study was to examine the differences in efficacy and tolerability between the combination of granisetron plus dexamethasone and granisetron alone for the treatment of PONV.

Methods

This study was a randomized, double-blind trial conducted at Toride Kyodo General Hospital (Toride, Ibaraki, Japan). Men and women aged 25 to 65 years and experiencing emetic symptoms after laparoscopic cholecystectomy were eligible for the study. Patients received IV therapy with either granisetron 40 μg/kg alone or with dexamethasone 8 mg. Patients were observed for 24 hours. Emetic episodes and the need for a rescue antiemetic were recorded by nursing staff, who were blinded to treatment assignment.

Results

One hundred patients (63 women, 37 men; mean [SD] age, 47 [10] years; range, 25-65 years) were enrolled; 50 patients were randomized to each treatment group. No significant differences in baseline demographic or clinical characteristics were observed between the groups. Complete control of established PONV, defined as no emetic symptoms and no need for another rescue antiemetic medication, occurred in significantly more patients who received the combination (49/50 [98%]) than in those who received granisetron alone (41/50 [82%]) (P = 0.008). No clinically important adverse effects due to the study drugs were observed in either group.

Conclusion

In this study population of patients experiencing post-cholecystectomy emesis, the combination of granisetron plus dexamethasone was more efficacious than granisetron alone for the treatment of PONV. Tolerability between the 2 treatments was similar.     

Effect of Metoclopramide Dose on Preventing Emesis After Oral Administration of N-Acetylcysteine for Acetaminophen Overdose

Objective: To determine the effect of the metoclopramide dose on the prevention of vomiting of N-acetylcysteine in acetaminophen overdose. Methods: Patients with acetaminophen ingestions receiving metoclopramide prior to emergency department administration of N-acetylcysteine were included. Emergency Department and poison center records were reviewed for administration of metoclopramide pre-N-acetylcysteine and incidence of subsequent vomiting. The treatment group was defined as patients receiving high-dose metoclopramide (20–50 mg intravenously) prior to the loading dose of N-acetylcysteine. Controls were patients receiving standard-dose (<20 mg intravenously) metoclopramide prior to loading dose of N-acetylcysteine. Outcome was vomiting within 60 minutes of N-acetylcysteine administration. Results: Twelve of 19 patients (63%) receiving standard-dose metoclopramide vomited N-acetylcysteine. Only 5 of 23 patients (22%) receiving high-dose metoclopramide vomited N-acetylcysteine (crude odds ratio: 6.2; 95% CI [1.3–30.3]). After controlling for confounding in the logistic regression model, the effect of high-dose metoclopramide in preventing vomiting of N-acetylcysteine remained significant (adjusted odds ratio: 17.0; 95% CI [2.6–110.0]). Conclusion: This study supports the efficacy of high-dose metoclopramide to prevent emesis after the oral loading dose of N-acetylcysteine.     

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.     

微剂量异丙酚对术后恶心呕吐的作用

目的:异丙酚为镇静催眠药物,有研究表明其可能具有治疗术后恶心呕吐的作用。本研究通过对60例择期腹部肿瘤手术患者的观察,了解其对术后恶心呕吐的作用。方法:60例ASAI-Ⅱ择期腹部肿瘤手术患者,随机分为实验组和对照组,实验组在麻醉苏醒后静脉注入异丙酚0.2 mg/kg,对照组使用生理盐水2 mL。观察麻醉苏醒后6h内两组患者恶心呕吐的发生率以及镇静/清醒评分。结果:实验组在麻醉清醒后6 h内恶心发生率(16.6％)明显低于对照组(26.6％),P<0.05,但是呕吐发生率没有差异。结论:微剂量的异丙酚用于直接治疗术后恶心呕吐有一定的疗效,但是具体临床使用剂量以及时机尚需要进一步的研究。     

A double-blind, multicentre comparison of intravenous dolasetron mesilate and metoclopramide in the prevention of nausea and vomiting in cancer patients receiving high-dose cisplatin chemotherapy

The potent serotonin receptor (5-HT₃) antagonists are new highly selective agents for the prevention and control of chemotherapy-induced nausea and vomiting that have been shown to be comparable to or more effective than traditional metoclopramide regimens. This study was designed to compare the antiemetic efficacy of dolasetron and metoclopramide in chemotherapy-naive and non-naive cancer patients receiving high-dose cisplatin-containing chemotherapy. This multicentre, double-blind, randomized trial compared the efficacy and safety of single i.v. doses of dolasetron mesilate salt (1.2 or 1.8 mg/kg) and metoclopramide (7 mg/kg) in 226 patients for the prevention of acute emesis and nausea associated with the administration of high-dose (80 mg/m²) cisplatin. Efficacy and safety were evaluated for 24 h. Complete responses were achieved by 57%, 48%, and 35% of patients given dolasetron mesilate 1.8 mg/kg (P=0.0009 vs metoclopramide), dolasetron mesilate 1.2 mg/kg (P=0.0058 vs metoclopramide), and metoclopramide, respectively. Overall, dolasetron was significantly more effective than metoclopramide for time to first emetic episode, nausea, patient satisfaction, and investigator global assessment of efficacy. Males, chemotherapy-naive patients, and alcoholics had higher response rates. Dolasetron was well tolerated, with mild-to-moderate headache most commonly reported. Twelve percent of patients receiving metoclopramide reported extrapyramidal symptoms compared with 0% of patients receiving dolasetron. In conclusion, dolasetron mesilate was effective for the prevention of CINV with high-dose cisplatin. Single i.v. doses of dolasetron mesilate were more effective than 7 mg/kg metoclopramide in preventing nausea and vomiting induced by highly emetogenic cisplatin-containing chemotherapy. In addition, 1.8 mg/kg dolasetron mesilate consistently produced the highest response rates and appears to be the most effective dose for further clinical development.     

Intermediate dose metoclopramide is not more effective than standard dose metoclopramide for patients who present to the emergency department with nausea and vomiting: a pilot study

Objective: To determine whether intermediate dose metoclopramide is more effective than standard dose metoclopramide for patients who present to the ED with nausea and vomiting. Methods: This prospective, single‐blind, randomized trial was conducted in the ED of two community teaching hospitals in a convenience sample of adult patients who presented to ED with nausea and vomiting. Patients were randomized to receive either 10 mg metoclopramide IV or 0.4 mg/kg IV (up to a maximum dose of 32 mg). The outcomes measured were: change in nausea score (measured on a 11‐point verbal rating scale), requirement for other anti‐emetic drug administration, and presence of side‐effects. Results: Fifty‐eight patients were eligible for analysis (34 in 10 mg group and 24 in 0.4 mg/kg group). Median reduction in nausea score in 10 mg group was four (range 0–10, 95% CI 3–5) compared with five for 0.4 mg/kg group (range ?1–10, 95% CI 4–6). This difference was not statistically significant (P = 0.629). Five patients in the 10 mg group required rescue anti‐emetic, compared with three in the 0.4 mg/kg group (P = 1.00). There were no side‐effects in the 10 mg group and two in the 0.4 mg/kg group. Conclusion: This study suggests that there is no difference in effectiveness between 10 mg and 0.4 mg/kg of metoclopramide in the ED population with nausea and vomiting.     

Aprepitant vs. Multimodal Prophylaxis in the Prevention of Nausea and Vomiting following Extended‐Release Epidural Morphine

Background: Extended‐release epidural morphine (EREM) is an effective option for postoperative analgesia following major orthopedic surgery; however, postoperative nausea/vomiting (PONV) is a recognized limitation. The incidence of PONV following prophylactic aprepitant, a neurokinin‐1 antagonist, was compared with prophylactic multimodal antiemetic therapy in patients receiving EREM for postoperative analgesia following unilateral primary total knee arthroplasty (TKA). Methods: Prospectively collected quality assurance data were examined with Institutional Review Board approval. A sequential, open‐label, active matched case‐control study compared PONV following EREM in patients receiving ondansetron and dexamethasone, and either metoclopramide, diphenhydramine, or prochlorperazine every 6 hours for the 48‐hour study period, to patients receiving aprepitant 40 mg given as a single oral dose in the preoperative holding area. Cases were matched for procedure (TKA), age, epidural morphine dose, and known major risk factors for PONV (sex, smoking, previous PONV/motion sickness). Results: Twelve consecutive patients (3 male; 9 female) receiving aprepitant prior to EREM were matched to 12 patients of the same sex of similar age (range 51 to 84 years.) and EREM dose (range 5 to 12.5 mg) receiving the multimodal regime. The incidence of PONV was significantly less for the aprepitant group where 3 of 12 (25%) had PONV compared with 9 of 12 (75%) in the multimodal group (P = 0.039, Fisher's Exact Test; odds ratio = 0.11; 95% CI: 0.018 to 0.706, P = 0.03). Conclusion: While aprepitant significantly reduced the incidence of PONV compared with a multimodal antiemetic regime, used alone it did not eliminate PONV.     

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.     

Intravenous lysine clonixinate for the acute treatment of severe migraine attacks: a double-blind, randomized, placebo-controlled study

Background

Several nonsteroidal anti-inflammatory drugs (NSAIDs) have been shown to be effective in the treatment of migraine. However, few commercially available NSAIDs can be administered IV. Lysine clonixinate (LC), an NSAID derived from nicotinic acid, has been proved effective in various algesic syndromes (eg, renal colic, muscular pain, nerve compression, odontalgia). The oral formulation of LC has been shown to be effective in the treatment of migraine of moderate severity.

Objective

The aim of this study was to assess the efficacy and tolerability of the IV formulation of LC in the treatment of severe migraine.

Methods

This double-blind, randomized, placebo-controlled, prospective study enrolled patients with severe migraine (without aura) as defined by the criteria of the International Headache Society. When patients presented to a neurology hospital with an outpatient headache unit (Instituto de Neurologia Deolindo Couto, Rio de Janeiro, Brazil) with a severe migraine attack that had lasted <4 hours, they were randomized to 1 of 2 groups (IV placebo [25 mL of 0.9% saline] or IV LC [21 mL of 0.9% saline plus 4 mL of LC 200 mg]). Headache intensity and adverse effects (AEs) were assessed before (0 minute) and 30, 60, and 90 minutes after study drug administration. Rescue medication was available 2 hours after study drug administration, and its use was compared between groups.

Results

Thirty-two patients (23 women, 9 men; mean [SD] age, 32 [2] years; range, 18-58 years) entered the study. Twenty-nine patients (21 women, 8 men; mean [SD] age, 32 [2] years; range, 18-56 years) completed the study. Three patients (all in the placebo group) did not complete the study (1 patient was unable to rate the pain severity after drug administration and 2 patients refused IV drug administration). Among study completers, 17 patients received LC and 12 placebo. At 30 minutes, 1 patient (8.3%) in the placebo group and 5 patients (29.4%) in the LC group were pain free; the between-group difference was not statistically significant. At 60 and 90 minutes, respectively, 3 (25.0%) and 5 (41.7%) patients in the placebo group and 12 (70.6%) and 14 (82.4%) patients in the LC group were pain free (P = 0.021 and P = 0.028 between groups at 60 and 90 minutes, respectively). Six patients (50.0%) in the placebo group and 1 patient (5.9%) in the LC group required rescue medication at 2 hours (P = 0.010 between groups). Three patients (25.0%) in the placebo group experienced AEs, including vomiting, dizziness, and malaise (1 patient [8.3%] each); 11 patients (64.7%) in the LC group experienced 1 AE, including burning pain at the injection site (5 patients [29.4%]), heartburn (4 patients [23.5%]), and dizziness and malaise (1 patient [5.9%] each) (P = 0.025).

Conclusions

NSAIDs administered by the IV route cannot be used routinely in an outpatient environment, although an attempt to improve drugs in this class is clearly justified. This study demonstrated that IV LC was effective and well tolerated in the treatment of severe migraine attacks. This finding differs from results with the oral formulation, which is effective only in migraine of moderate severity.     

Antiemetic effects of midazolam added to fentanyl-ropivacaine patient-controlled epidural analgesia after subtotal gastrectomy: A prospective, randomized, double-blind, controlled trial

Background: Nausea and vomiting are frequent adverse effects of patient-controlled epidural analgesia (PCEA) with opioids.Objective: This study was designed to assess the antiemetic effect of midazolam added to fentanyl—ropivacaine PCEA.Methods: In a prospective, randomized, double-blind, controlled trial, smoking patients with gastric cancer undergoing elective subtotal gastrectomy were evenly allocated to 1 of 2 treatment groups to manage postoperative pain: 0.2% ropivacaine mixed with fentanyl 4 μg/mL and midazolam 0.2 mg/mL (test group) or 0.2% ropivacaine mixed with fentanyl 4 μg/mL (control group). The PCEA infusion was set to deliver 4 μL/h of the study solution, with a bolus of 2 mL per demand and a 15-minute lockout time. The incidence of postoperative nausea and vomiting (PONV), pain intensity, sedation score, usage of rescue analgesia and rescue antiemetic, respiratory depression, urinary retention, and pruritus were recorded at 2, 6, 12, 24, 48, and 72 hours after surgery. Total infused volume of PCEA at 72 hours after surgery was measured.Results: A total of 60 patients were approached and randomized to treatment. No patients were excluded by exclusion criteria and all enrolled patients completed this study. Incidence of nausea (7% vs 33%; P = 0.02) in the test group was significantly lower than in the control group. The overall frequency of PONV in the test group was significantly less than that of the control group (7% vs 40%; P = 0.006). In addition, the mean (SD) infused volume of PCEA in the test group was significantly lower than that in the control group (392.3 [68.9] vs 351.2 [49.8] mL; P = 0.01). However, there were no significant differences in pain intensity, usage of rescue antiemetics and rescue analgesics, and mild pruritus between groups. No patient reported moderate or severe sedation, respiratory depression, or hypoxemia. In addition, there were no severe adverse events.Conclusions: Midazolam added to fentanyl-ropivacaine PCEA was associated with a significant reduction in the incidence of PONV compared with fentanyl-ropivacaine alone, and a significant decrease in the amount of PCEA administered without a significant increase in adverse events in these patients who underwent subtotal gastrectomy.     

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     

Tropisetron versus metoclopramide for the treatment of nausea and vomiting in the emergency department: A randomized,double‐blinded,clinical trial

Aim: We aimed to compare the relative efficacy of tropisetron and metoclopramide in treating nausea/vomiting in undifferentiated ED patients. Methods: We undertook a randomized, double‐blinded, clinical trial. Adult patients requiring treatment for nausea/vomiting were randomly assigned to either tropisetron (5 mg) or metoclopramide (10 mg), by i.v. bolus. The primary end‐point was incidence of vomiting. Secondary end‐points were decrease in nausea score from baseline (0–100 VAS), the requirement of ‘rescue’ anti‐emetics, ongoing nausea over 48 h and side‐effects. Results: Fifty patients were enrolled in each group. The demographic variables, presenting complaints and nausea scores at baseline did not differ (P > 0.05). By 180 min, two (4.0%) and nine (18.0%) patients had vomited in the tropisetron and metoclopramide groups respectively (difference 14.0%, 95% CI 0.1–28.0, P= 0.05). Also, there were two and 20 episodes of vomiting respectively. Vomiting rates were 0.02 and 0.16 episodes/person‐hour (difference 0.14 episodes/person‐hour, 95% CI 0.07–0.21, P < 0.001) respectively. By 60 min and thereafter, the decrease in nausea score from baseline was greater (although not significantly so) in the tropisetron group. At 180 min, the decreases were 47.9 mm and 37.0 mm respectively (difference 10.9 mm, 95% CI ?0.7–22.6). Five (10.0%) and 13 (26.0%) patients required a rescue anti‐emetic respectively (difference 16.0%, 95% CI ?0.7–32.7, P= 0.07). Of patients followed up, 13/47 (27.7%) and 20/49 (40.8%) had ongoing nausea respectively (difference 13.2%, 95% CI ?7.7–34.0, P= 0.25). The tropisetron group had less akathisia. Conclusions: Tropisetron was associated with a significantly lower vomiting rate and shows promise as an alternative anti‐emetic in the ED.     

Effects of 2 Different Doses of Pregabalin on Morphine Consumption and Pain After Abdominal Hysterectomy: A Randomized, Double-Blind Clinical Trial

Background

Pregabalin has a similar pharmacologic profile to that of its developmental predecessor gabapentin but has shown greater analgesic activity in rodent models of neuropathic pain.

Objective

The objective of the study was to compare the effects of 2 different doses of pregabalin and placebo on postoperative pain and morphine consumption.

Methods

Ninety patients who underwent abdominal hysterectomy were included in the study and randomly divided into 3 groups in a doubled-blinded manner. They were given 150 mg of pregabalin (group P300, n = 30), 300 mg of pregabalin (group P600, n = 30), or placebo capsules (group C, n = 30) 4 hours before the induction of anesthesia; they received a second dose of the drug 12 hours postoperatively. Morphine consumption, nausea, and vomiting, visual analogue scale-pain intensity (VAS-PI), sedation scores, and dissatisfaction scores were recorded in the postanesthesia care unit (PACU) and at 2, 4, 6, and 24 hours after operation.

Results

Morphine consumption at 24 hours was 40.80 (3.42) mg, 33.79 (5.77) mg, and 46.97 (6.67) mg in groups P300, P600, and C, respectively (P < 0.001). VAS-PI scores at movement and at rest in the PACU and at 2, 4, and 6 hours decreased in group P600 (P < 0.01). In the PACU and at 2, 4, and 6 hours, the sedation scores were increased in group P600 compared with the scores in group C (P < 0.001, P < 0.001, P = 0.01, P = 0.006, respectively). Patient satisfaction was higher in group P600 than in group C for all time points (P < 0.001, P < 0.001, P < 0.001, P = 0.001, P < 0.001, respectively). There were no statistically significant differences between the groups for side effects such as nausea, vomiting, and dizziness (P = 0.58).

Conclusions

Pregabalin at a total dose of 600 mg, administered before operation and at 12 hours postoperatively after abdominal hysterectomy, reduced morphine consumption and pain intensity and increased patient satisfaction. No significant differences in side effects were observed between the study groups.     

A randomized controlled trial of two different interventions for the prevention of postoperative nausea and vomiting: total intravenous anaesthesia using propofol and remifentanil versus prophylactic palonosetron with inhalational anaesthesia using sevoflurane-nitrous oxide

Total intravenous anaesthesia (TIVA) can reduce the risk of postoperative nausea and vomiting (PONV) almost as much as a single antiemetic. This study compared TIVA (using propofol and remifentanil) with prophylactic palonosetron (a 5-hydroxytryptamine type 3 receptor antagonist) combined with inhalation anaesthesia using sevoflurane in 50% nitrous oxide, for the prevention of PONV. Patients were randomly assigned to one of two prophylactic interventions: (i) palonosetron 0.075 mg, intravenously before induction of inhalation anaesthesia (palonosetron group); and (ii) TIVA (propofol target blood concentration 2.5-6.0 μg/ml; remifentanil target blood concentration 2.5-6.0 ng/ml; TIVA group). Nausea/vomiting occurrence and severity were monitored immediately after the end of surgery for 24 h. The incidence of PONV was around 50% in both groups and the severity of nausea was similar in both groups. Prophylactic palonosetron with inhalational anaesthesia using sevoflurane in 50% nitrous oxide reduced the incidence of PONV after gynaecological laparoscopic surgery almost as much as TIVA using propofol and remifentanil.     

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.     

Use of a prophylactic antiemetic with morphine in acute pain: randomised controlled trial

Objective

The aim of this study was to compare the incidence of nausea and vomiting in patients with acute pain treated with morphine along with prophylactic metoclopramide or placebo.

Method

A randomised controlled trial was carried out on patients requiring morphine for acute pain in the emergency department (ED) setting. Children under the age of 12, patients who had been vomiting or had already received prehospital analgesia, and those unable to give consent were excluded. All patients were given either metoclopramide (10 mg) or placebo (normal saline) followed by intravenous morphine. Pain scores (measured on a visual analogue scale) before and after morphine administration, all incidents of nausea or vomiting, the dose of morphine, and the patients'' demographic data were recorded. Fisher''s exact test was used for comparing the two groups of patients.

Results

A total of 259 patients were recruited. There were 123 patients in the metoclopramide group (age range 15–94 years; median age 53) and 136 patients in the placebo group (age range 17–93 years; median age 52.5). The overall incidence of nausea and vomiting in the whole study population was 2.7%, (1.6% in the metoclopramide group and 3.7% in the placebo group). The difference between the two groups was not statistically significant (Fisher''s exact test = 0.451; p = 0.3; z‐test statistic = 1.02; 95% CI –6% to 2%).

Conclusion

When intravenous morphine is administered for acute pain, the overall incidence of nausea and vomiting is low, regardless of whether these patients are given prophylactic metoclopramide or not.