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A randomized controlled trial of the antiemetic effect of three doses of ondansetron after strabismus surgery in children.

METHODS: One hundred and thirty-one healthy children, aged 31-152 months, undergoing strabismus surgery under general anaesthesia, were randomly allocated to one of four groups: group A received 0.04 mg.kg-1 ( identical with 1 mg.m-2) of ondansetron, group B 0.1 mg.kg-1 ( identical with 2.5 mg.m-2), group C 0.2 mg.kg-1 ( identical with 5 mg.m-2) and group D placebo, given intravenously following induction of anaesthesia. Morphine 0.15 mg.kg-1 was given intravenously, intraoperatively, to provide postoperative analgesia. Hourly records of emetic episodes were made for 24 h. RESULTS: A considerably higher proportion of children suffered emesis in the placebo group compared to the active treatment groups taken together, during the first 8 h of postoperative care (76% vs. 45%, P=0.002). During the first 8 h, only 25% of those in treatment group C suffered emesis, the number-needed-to-treat was 3. There was a statistically significant decrease in the chance of vomiting with increasing dose of ondansetron (P=0.03). By 24 h, the difference in the rate of emesis was less marked but still statistically significant (90% vs. 69%, P=0.03). CONCLUSION: Overall, children given ondansetron had less than one-half the risk of vomiting compared to those given placebo (hazard ratio 0.46, 95% confidence interval 0.29-0.74). The mean number of emetic episodes declined from 2.73 in the placebo group to 1.92 in treatment group C. There was no difference in the incidence of side-effects between groups.

Antiemetics↗

A nonpeptide vasopressin V(1a) receptor antagonist, SR 49059, does not prevent cisplatin-induced emesis in piglets.

We determined the pharmacological and the antiemetic properties of SR 49059, a selective nonpeptide V(1a) receptor antagonist, on cisplatin-induced emesis in the piglet. Firstly, we clearly demonstrate that SR 49059 is a potent V(1a) receptor antagonist in vitro and in vivo in the piglet. In binding studies, [3H]-SR 49059 exhibited high affinity for V(1a) receptors in piglet liver membranes (K(d) of 0.76 +/- 0.12 nM and B(max) of 138 +/- 22 fmol/mg prot.). In vivo, in decerebrate piglets, SR 49059 (1 mg/kg iv) antagonized AVP (500 ng/kg iv)-induced hypertension for at least 150 min and also blocked, for at least 270 min at 3 mg/kg iv, the pressor responses to exogenous LVP. After single and repeated iv or icv administration, we studied the antiemetic properties of SR 49059 on cisplatin-induced emesis in piglets. Animals receiving an emetic dose of cisplatin (5.5 mg/kg, iv) were observed continuously for 60 h. Piglets acting as controls were iv administered with vehicle 15 min prior to cisplatin infusion (T0(-15min)), while experimental animals received a single iv administration of SR 49059 at the dose of 1 or 3 mg/kg. In additional piglets, we administered SR 49059 (3 mg/kg) every 12 h from T0(-15min) to T48(-15min) (cumulative dose, 15 mg/kg). Another set of animals - observed only during the acute phase - was administered with SR 49059 (10 mg/kg) every 3 h from T0(-15min) to T15(-15min) (cumulative dose, 60 mg/kg). Lastly, 10 piglets were given a bilateral icv injection of SR 49059 (500 microg and 1500 microg/side) 1 h prior to cisplatin infusion. In all groups treated with SR 49059, the latency of the first emetic episode and the incidence of vomiting during the acute, the delayed and the cumulative phases remained statistically similar to that observed in controls, suggesting that V(1a) receptors are not involved in the onset and completion of nausea and vomiting.

Animals↗

Retching and vomiting in neurologically impaired children after fundoplication: predictive preoperative factors.

BACKGROUND/PURPOSE: In neurologically impaired children, retching and recurrent vomiting are common after Nissen fundoplication. The aim of this study was to identify whether there are preoperative factors that predict their occurrence. METHODS: Twenty neurologically impaired children (8 boys, 12 girls; age range, 3 months to 8 years) were studied prospectively by taking a detailed history of behaviors and symptoms associated with feeding before and after Nissen fundoplication for gastroesophageal reflux. RESULTS: Preoperatively, children could be classified into 2 groups. Children in group A had symptoms suggestive of only gastroesophageal reflux (effortless "vomiting" or regurgitation), whereas children in group B exhibited one or more features associated with activation of the emetic reflex (pallor, sweating, retching, forceful vomiting). Postoperatively 0 of 8 in group A retched compared with 8 of 12 in group B (P <.005, Fishers Exact test). CONCLUSIONS: Children at high risk of retching, and ultimately vomiting, after antireflux surgery may be identified clinically preoperatively. They have symptoms that are specifically caused by activation of the emetic reflex rather than to gastroesophageal reflux. In these cases, antireflux surgery could be considered inappropriate and hence be avoided.

Central Nervous System Diseases↗

New agents, new treatment, and antiemetic therapy.

With the introduction of newer antineoplastic agents, the challenge for supportive care is enlarging. For the most part, these targeted therapies are given in addition to more classic anticancer drugs, either in combination or in sequence, underscoring the need for prevention of emesis and attention to all treatment toxicities. Strategies for preventing these side effects need to be investigated while appropriately addressing more familiar problems such as emesis. Two directions for improving emetic control are clear. First is the development of newer antiemetics that enhance current control rates, and second is the proper use of existing agents in all emetic settings. This report outlines the rationale behind the development of neurokinin type 1 antagonists, and reviews consensus recommendations in the prevention of acute and delayed emesis.

Antiemetics↗

[Postoperative nausea and emesis: mechanisms and treatment].

The incidence of postoperative emetic symptoms in patients varies between 3 and 91%. Nausea and emesis remain the most common as well as unpleasant side-effects experienced by patients following general anaesthesia, both in the ambulatory and non-ambulatory care setting. Furthermore, emesis carries the risk of severe postoperative complications and is associated with additional costs. Multiple factors are associated with an increased risk of developing postoperative nausea and emesis including age, gender, weight, preexisting disease, as well as anaesthetic and surgical procedures. Routine antiemetic prophylaxis is not currently advisable in patients with a low Emesis Risk, due to undesirable side-effects of antiemetics and additional costs. However, anti-emetic prophylaxis is recommended for patients with an increased risk. Besides administration of antiemetics, other factors that may provoke postoperative emesis need to be considered such as gastric distension, early mobilisation, insufficient analgesia, choice of anaesthetic drugs. High-risk patients may be anaesthetized with propofol, if possible. If symptoms do develop in the recovery room, tight fitting oxygen masks should be avoided and adequate hydration and analgesia ensured. To avoid side effects, antiemetics should be administered in minimally effective dosages. If emesis persists, combination of antiemetic drugs with different profiles of receptor action may be particularly useful.

Anesthesia↗

[A comparison of the effect of propofol in 3 subhypnotic doses within the framework of tumor chemotherapy].

PURPOSE: In anaesthesia and critical care propofol is often used as a hypnotic or sedative. There are some reports showing propofol as a mood-altering drug. The use of propofol in subanaesthetic doses, for example in antineoplastic chemotherapy, led to similar results. In previous studies it was hypothesised that these mood effects could also reduce chemotherapy-induced nausea and vomiting. The present prospective randomised double-blind study evaluated mood effects of different subanaesthetic doses of propofol in oncology patients who received antineoplastic chemotherapy. METHODS: Propofol was applied in a double-blind and randomised manner as follows (N = 8 per group): Initial bolus of 0.1 mg/kg followed by a continuous infusion of 1.0 mg/kgxh (group 1), 1.5 mg/kgxh (group 2) or 2.0 mg/kgxh (group 3). Dependent variables were as behavioural (i.e. nausea and vomiting) as aspects of mood as somatic aspects. RESULTS: Subanaesthetic doses of propofol showed different effects. In respect of somatic variables some well-known results were replicated, showing highest reduction of blood pressure under highest dose of propofol. With regard to psychic variables no deterioration of mood or feeling tone was seen. Rather, a reduction of anxiety and especially under 2.0 mg/kgxh an induction of well-being occurred. However, even propofol was used as the only "anti-emetic" drug, patients reported no induction of nausea and vomiting during antineoplastic chemotherapy. CONCLUSIONS: Further studies are needed to specify the "anti-emetic" effects of subhypnotic propofol in antineoplastic chemotherapy. Especially a comparison with a standard drug for the prevention of nausea and vomiting, such as ondansetron, will have to be conducted. The results of this study showed that a dose of propofol of 1.0 mg/kgxh after an initial bolus of 0.1 mg/kg is a useful reference dose.

Adult↗

Protection against the staphylococcal enterotoxin-induced intestinal disorder in the monkey by anti-idiotypic antibodies.

The staphylococcal enterotoxin serotype B (SEB)-induced enteric intoxication and the immediate-type reaction in the skin of unsensitized monkeys was used to define whether agents competing with SEB for target cell receptors may inhibit pathophysiological effects. For this purpose a duodenal provocation test was developed by use of a pediatric gastroscope, allowing the evaluation of the influence of antagonists on the intestinal disorder upon SEB challenge at the same duodenal site. First, carboxymethylation of histidine residues of SEB caused a complete loss of emetic and skin-sensitizing activity without changing the immunological specificity. However, carboxymethylated SEB is a strong inhibitor of enteric intoxications and immediate-type skin reactions upon SEB challenge. Second, after immunization of BALB/c mice with monoclonal anti-SEB antibodies, monoclonal antiidiotypic antibodies (anti-Id) were obtained by the "hybridoma technique" and purification by idiotype-affinity chromatography. Anti-Id specifically inhibited the binding of horseradish peroxidase-labeled anti-SEB to the ligand, and SEB blocked as well the interaction of these two antibody species, indicating a high degree of binding-site selectivity. Anti-Id completely protected against emetic response and diarrhea upon duodenal provocation with SEB and inhibited immediate-type skin reactions as well. Further, anti-Id acted as an antagonist without triggering biologic functions themselves. This shows that anti-Id constitute a useful tool to protect against a bacterial toxin-induced intestinal disorder.

Animals↗

Impact of oliceridine versus sufentanil on postoperative nausea and vomiting in patients undergoing thyroid surgery: a prospective, double-blind, randomized controlled trial.

PURPOSE: Postoperative nausea and vomiting (PONV) is a common complication following thyroid surgery, often exacerbated by opioid use. Oliceridine, a novel G protein-biased &#x3bc;-opioid receptor agonist, may reduce opioid-related adverse events. This study aimed to compare the impact of oliceridine versus sufentanil on the incidence and severity of PONV in patients undergoing thyroid surgery. PATIENTS AND METHODS: In this prospective, double-blind, randomised controlled trial conducted between May 2025 and February 2026, 232 patients scheduled for thyroid surgery were randomly assigned to receive either oliceridine or sufentanil for intraoperative analgesia. The primary outcome was the incidence of PONV during the first 48&#x2009;h postoperatively. Secondary outcomes included PONV severity, need for rescue anti-emetics, postoperative pain scores, recovery quality, and other adverse events. RESULTS: The incidence of PONV within 48&#x2009;h postoperatively was significantly lower in the oliceridine group [13/107 (12%)] compared with the sufentanil group [31/110 (28%)] (OR = 0.35, 95% CI: 0.17-0.72, p&#x2009;=&#x2009;0.006). Postoperative pain scores, rescue analgesia requirements, and Quality of Recovery-15 scores were comparable between the two groups (p&#x2009;>&#x2009;0.05). Besides, exploratory unadjusted analyses revealed fewer rescue anti-emetics: O group 8/107 (8%) vs S group 25/110 (23%) (OR = 0.27, 95% CI: 0.12-0.64, p&#x2009;=&#x2009;0.002); and less abdominal distension: O group 4/107 (4%) vs S group 19/110 (17%) (OR = 0.19, 95% CI: 0.06-0.57, p&#x2009;=&#x2009;0.001). CONCLUSION: For young ASA I-II patients undergoing thyroid surgery, oliceridine yields adequate postoperative analgesia and lower PONV rates versus sufentanil. Additional trials involving high-intensity surgical procedures are needed to confirm consistent equivalence.

Humans↗

Double-blind randomized trial of lorazepam versus placebo with methylprednisolone for control of emesis due to non-cisplatin containing chemotherapy.

Fifty-three breast cancer patients receiving adjuvant chemotherapy entered a double-blind randomized trial of lorazepam 2.5 mg orally prior to chemotherapy and repeated after 12 hours (Arm A) versus placebo (Arm B) with methylprednisolone (MPN) 375 mg in 3 equal doses: 125 mg i.v. prior to chemotherapy and repeated i.m. 6 and 12 hours later. Adjuvant therapy with 5-fluorouracil 600 mg/m2, 4'-epi-doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2 (FEC) day 1 was alternated every 21 days with cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, 5-fluorouracil 600 mg/m2 (CMF) day 1 for a total of 12 courses. The majority of patients experienced greater than or equal to 5 emetic episodes with FEC therapy (Arm A = 52%; Arm B = 55%). Mild and moderate nausea were reported by 60% and 68% of patients in Arms A and B, respectively. With CMF therapy complete control of emesis was observed in 33% (Arm A) and 35% (Arm B) of patients. The addition of lorazepam did not improve results either with FEC or CMF. Sedation was experienced by 86 to 92% of patients treated with lorazepam and amnesia was observed in 48-50% of cases. FEC therapy must be considered a highly emetic regimen and antiemetic therapy planned accordingly.

Adult↗

Electroacupuncture for refractory acute emesis caused by chemotherapy.

PURPOSE: To evaluate the efficacy of electroacupuncture in preventing anthracycline-based chemotherapy-related nausea and emesis refractory to combination 5HT(3)-antagonist and dexamethasone. PATIENTS AND METHODS: Cancer patients with refractory emesis after their first cycle of doxorubicin-based chemotherapy were accrued into this study. Electroacupuncture was given during the second cycle of chemotherapy. Each patient was evaluated for the number of emetic episodes and grade of nausea within the first 24 hours after chemotherapy and electroacupuncture. RESULTS: Forty-seven of a total of 317 patients screened were eligible for this study. Of these, 27 patients agreed to participate. Twenty-six (26; 96.3%) of them had significant reduction in both nausea grade and episodes of vomiting after electroacupuncture. There was complete response with no emetic episodes in 37%. Subjectively, 25 (92.6%) of the total 27 patients believed that acupuncture was an acceptable procedure and was helpful in reducing emesis. Electroacupuncture was well-tolerated with a median pain score of 3 of 10. CONCLUSION: Electroacupuncture is well-tolerated and effective as an adjunct in reducing chemotherapy-related nausea and emesis.

Adult↗

Studies of drugs given before anaesthesia. XXIV: Metocloramide with morphine and pethidine.

When given with pethidine 100 mg or morphine 10 mg as preanaesthetic medication, 10 and 20 mg of metoclopramide cause a reduction in postoperative nausea and vomiting in women undergoing a standard operation with a standard anaesthetic technique. The preoperative emetic effects of pethidine are almost completely abolished by metoclopramide. An additional 10-20 mg of metoclopramide, given i.m. at the end of the operation markedly reduces the emetic effects of pethidine premedication but has less effect when morphine has been given. The evidence suggests that the ineffectiveness of metoclopramide, relative to other antiemetics, is because of its brevity of action.

Adult↗

Ergometrine, oxytocin and extradural analgesia.

Blood loss and the incidence of emetic sequelae were assessed in 148 patients undergoing midcavity forceps delivery under continuous lumbar extradural analgesia. Five units of oxytocin i.v. was found to be as effective as ergometrine 0.5 mg i.v. in reducing blood loss at delivery. Nausea, retching or vomiting occurred in 35 (46%) of the mothers who received ergometrine and in none of those who received i.v. oxytocin. The cardiovascular side-effects of ergometrine and oxytocin are reviewed and compared with special reference to patients with hypertension and heart disease. It is suggested that 5 units of oxytocin i.v. should be preferred in these high-risk patients. Because of the absence of an emetic action, i.v. oxytocin is preferable to i.v. ergometrine for patients receiving extradural analgesia.

Anesthesia, Epidural↗

Psychological adjunct to perioperative antiemesis.

In a prospective, randomized study, we have examined the effects of preoperative and preinduction positive suggestion on postoperative emetic sequelae. A total of 226 patients were allocated randomly to receive either positive suggestions or no suggestions. Those patients in the positive suggestion group were told before operation and on induction of anaesthesia that postoperative emetic sequelae would be greatly reduced by the use of two antiemetic drugs. Control patients were simply asked to participate in a study of postoperative well being with no mention of nausea or vomiting. Nausea, vomiting or retching, and antiemetic administration were measured in the first 24 h after operation. Antiemetic administration in the positive suggestion group was 16.5% less than in the control group (P = 0.03) but there was no significant difference between the groups in nausea or vomiting-retching.

Adult↗

Combination of ondansetron and dexamethasone in the prophylaxis of postoperative nausea and vomiting.

We studied 100 ASA I-II females undergoing general anaesthesia for major gynaecological surgery, in a prospective, double-blind, placebo-controlled, randomized study. Patients received one of four regimens for the prevention of postoperative nausea and vomiting (PONV): ondansetron 4 mg (n = 25), dexamethasone 8 mg (n = 25), ondansetron with dexamethasone (4 mg and 8 mg, respectively, n = 25) or placebo (saline, n = 25) There were no differences in background factors or factors related to operation and anaesthesia, morphine consumption, pain or side effects between groups. The incidence of nausea and emetic episodes in the ondansetron with dexamethasone group was lower than in the placebo (P < 0.01), ondansetron (P < 0.05) and dexamethasone (P = 0.057) groups. There were no differences between ondansetron and dexamethasone, and both were more effective than placebo (P < 0.05 and P < 0.01, respectively). Dexamethasone appeared to be preferable in preventing nausea than emetic episodes. Fewer patients in the ondansetron with dexamethasone group needed antimetic rescue (P < 0.01 vs placebo and P < 0.05 vs ondansetron). We conclude that prophylactic administration of combined ondansetron and dexamethasone is effective in preventing PONV.

Adolescent↗

Propofol anaesthesia and postoperative nausea and vomiting: quantitative systematic review of randomized controlled studies.

We have analysed randomized controlled studies which reported the incidence of postoperative nausea and vomiting (PONV) after propofol anaesthesia compared with other anaesthetics (control). Cumulative data of early (0-6 h) and late (0-48 h) PONV were recorded as occurrence or non-occurrence of nausea or vomiting. Combined odds ratio and number-needed-to-treat were calculated for propofol as an induction or maintenance regimen, early or late outcomes, and different emetic events. This was performed for all control event rates and within a range of 20-60% control event rates. We analysed 84 studies involving 6069 patients. The effect of propofol on PONV was dependent mainly on the method of administration, time of measurement and range of control event rates. When all studies were included the number-needed-to-treat to prevent PONV with propofol was more than 9 when used for induction of anaesthesia and at best 6 when used for maintenance. Within the 20-60% control event rate range, best results were achieved with propofol maintenance to prevent early PONV: the number-needed-to-treat to prevent early nausea was 4.7 (95% confidence interval 3.8-6.3), vomiting 4.9 (4-6.1) and any emetic event 4.9 (3.7-7.1). Within the 20-60% control event rate, of five patients treated with propofol for maintenance of anaesthesia, one will not vomit or be nauseated in the immediate postoperative period who would otherwise have vomited or been nauseated. This may be clinically relevant. In all other situations the difference between propofol and control may have reached statistical significance but was of doubtful clinical relevance. Treatment efficacy should be established within a defined range of control event rates for meaningful estimates of efficacy and for comparisons.

Anesthetics, Intravenous↗

Ondansetron compared with metoclopramide in the treatment of established postoperative nausea and vomiting. The French Ondansetron Study Group.

We have studied 746 males and females undergoing general anaesthesia for any type of surgical procedure in a double-blind, controlled, randomized study. After experiencing at least one nausea and/or one emetic episode in the 6 h after recovery from anaesthesia, patients received either ondansetron 4 mg i.v. or metoclopramide 10 mg i.v. Patients were observed for postoperative nausea and vomiting (PONV) for 24 h after drug administration. Complete control of PONV was achieved more frequently in the ondansetron-treated patients compared with the metoclopramide-treated patients during the 24-h period (59% vs 41% (P < 0.001) and 44% vs 34% (P = 0.006) for emetic episodes and nausea, respectively). Furthermore, ondansetron was associated with greater patient satisfaction than metoclopramide (P < 0.001) with 49% and 32% of patients, respectively, very satisfied. The overall incidence of adverse events was similar in the ondansetron (7%) and metoclopramide (8%) groups. Ondansetron was as well tolerated and more effective than metoclopramide for all assessment criteria in the treatment of established PONV.

Adolescent↗

Effect of rofecoxib on platelet aggregation and blood loss in gynaecological and breast surgery compared with diclofenac.

BACKGROUND: Non-selective cyclooxygenase (COX) inhibitors or non-steroidal anti- inflammatory drugs (NSAIDs) are frequently omitted for perioperative pain relief because of potential side-effects. COX-2-selective inhibitors may have a more favourable side-effect profile. This study tested the hypothesis that the COX-2-selective inhibitor rofecoxib has less influence on platelet function than the NSAID diclofenac in gynaecological surgery. In addition, analgesic efficacy and side-effects of the two drugs were compared. METHODS: In this single-centre, prospective, double-blind, active controlled study, women undergoing vaginal hysterectomy (n=25) or breast surgery (n=25) under general anaesthesia received preoperatively 50 mg of rofecoxib p.o. followed 8 and 16 h later by two doses of placebo or three doses of diclofenac 50 mg p.o. at the same time points. We assessed arachidonic acid-stimulated platelet aggregation before and 4 h after the first dose of study medication, estimated intraoperative blood loss, and haemoglobin loss until the first morning after surgery. Analgesic efficacy, use of rescue analgesics, and side-effects were also recorded. RESULTS: In the rofecoxib group, stimulated platelet aggregation was disturbed less (P=0.02), and estimated intraoperative blood loss (P=0.01) and the decrease in haemoglobin were lower (P=0.01). At similar pain ratings, the use of anti-emetic drugs was less in the rofecoxib group (P=0.03). CONCLUSION: Besides having a smaller effect on platelet aggregation, one oral dose of rofecoxib 50 mg given before surgery provided postoperative analgesia similar to that given by three doses of diclofenac 50 mg and was associated with less use of anti-emetics and less surgical blood loss in gynaecological surgery compared with diclofenac.

Adult↗

Effect of intraoperative intravenous crystalloid infusion on postoperative nausea and vomiting after gynaecological laparoscopy: comparison of 30 and 10 ml kg(-1).

BACKGROUND: I.V. fluid administration has been shown to reduce postoperative nausea and vomiting (PONV). The optimum dose is unknown. We tested the hypothesis that administration of i.v. crystalloid of 30 ml kg(-1) would reduce the incidence of PONV compared with 10 ml kg(-1) of the same fluid. METHODS: A total of 141 ASA I female patients undergoing elective gynaecological laparoscopy were randomized, in double-blind fashion, to receive either 10 ml kg(-1) (n=71; CSL-10 group) or 30 ml kg(-1) (n=70; CSL-30 group) of i.v. compound sodium lactate (CSL). RESULTS: In the first 48 h after anaesthesia, the incidence of vomiting was lower in the CSL-30 group than in the CSL-10 group (8.6% vs 25.7%, P=0.01). Anti-emetic use was less in the CSL-30 group at 0.5 h (2.9% vs 14.3%, P=0.04). The incidence of severe nausea was significantly reduced in the treatment group at awakening (2.9% vs 15.7%, P=0.02), 2 h (0.0% vs 8.6%, P=0.04) and cumulatively (5.7% vs 27.1%, P=0.001). The numbers needed to treat to prevent vomiting, severe nausea and antiemetic use in the first 48 h were 6, 5 and 6, respectively. CONCLUSION: I.V. administration of CSL 30 ml kg(-1) to healthy women undergoing day-case gynaecological laparoscopy reduced the incidence of vomiting, nausea and anti-emetic use when compared with CSL 10 ml kg(-1).

Adult↗