Amisulpride: A New Drug for Management of Postoperative Nausea and Vomiting

2021 ◽  
pp. 106002802098701
Author(s):  
Stacy L. Haber ◽  
April Graybill ◽  
Ani Minasian

Objective: To review the pharmacology, efficacy, and safety of amisulpride and determine its role in the management of postoperative nausea and vomiting (PONV). Data Sources: A PubMed search (1946 to November 2020) using the terms amisulpride and APD421 was conducted. Study Selection and Data Extraction: Relevant reports on intravenous amisulpride were included. Data Synthesis: Six clinical trials were evaluated. In 4 trials on the prevention of PONV, a greater percentage of patients who received amisulpride 5 mg compared with placebo experienced a complete response (44%-60% vs 31%-33%, respectively, when used as monotherapy; 58% vs 47%, respectively, when used in combination with another antiemetic). In 2 trials on the treatment of PONV, a significantly greater percentage of patients who received amisulpride 10 mg compared with placebo experienced a complete response (31.4% vs 21.5%, respectively, in patients who had not received prophylaxis; 41.7% vs 28.5%, respectively, in patients who had received prophylaxis). Adverse effects included infusion site pain, chills, hypokalemia, procedural hypotension, and abdominal distension. Relevance to Patient Care and Clinical Practice: Amisulpride is effective for the management of PONV and may be less likely to cause QT prolongation and extrapyramidal symptoms than other dopamine antagonists. Additional information is needed on its use for chemotherapy-induced nausea and vomiting and in children. Conclusions: Amisulpride is an important new option for the multimodal management of PONV in adults, and it may be the preferred dopamine antagonist because of the more favorable safety profile that results from its unique pharmacological properties.

2002 ◽  
Vol 30 (2) ◽  
pp. 153-159 ◽  
Author(s):  
M. J. Paech ◽  
B. H. S. Lee ◽  
S. F. Evans

Gynaecological surgery is of high emetogenic potential and both total intravenous anaesthesia (TIVA) and prophylactic antiemetic therapy may reduce the incidence of postoperative nausea and vomiting (PONV). We studied 144 patients scheduled for day-case gynaecological laparoscopy in a randomized trial comparing balanced inhalational anaesthesia and prophylactic dolasetron (group I+D) with propofol TIVA and dolasetron (group T+D) or TIVA alone (group T). The primary outcome of “complete response” (no vomiting, no treatment for PONV) was not significantly different among groups (34%, 51%, 32%; groups I+D vs T+D vs T, P=0.12). During the first hour after surgery, group I+D had nausea of greater severity (P<0.03). During hospital admission, group T had more vomiting (P<0.03). From discharge until 24 hours postoperatively, 55% of group I+D experience nausea and 38% vomited. The incidence and severity of nausea were significantly lower in the TIVA groups (P<0.04 and < 0.05 respectively). There were no significant differences between groups T+D and T, although comparing all groups the complete response rate was highest and the post-discharge incidence and severity of nausea lowest in group T+D. In conclusion, propofol TIVA, with or without dolasetron, reduced postoperative nausea, but not perioperative vomiting or antiemetic requirement, when compared with inhalational anaesthesia plus dolasetron.


2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Renu Sinha ◽  
Dilip Shende ◽  
Souvik Maitra ◽  
Neeraj Kumar ◽  
Bikash Ranjan Ray ◽  
...  

Aim.Efficacy of granisetron and combination of granisetron and dexamethasone was evaluated for prevention of postoperative nausea and vomiting (PONV) in children undergoing elective strabismus surgery.Methods.A total of 136 children (1–15 years) were included. Children received either granisetron (40 mcg/kg) [group G] or combination of granisetron (40 mcg/kg) and dexamethasone (150 mcg/kg) [group GD]. Intraoperative fentanyl requirement and incidence and severity of oculocardiac reflex were assessed. PONV severity was assessed for first 24 hours and if score was >2, it was treated with metoclopramide. Postoperative analgesia was administered with intravenous fentanyl and ibuprofen.Results.The demographic profile, muscles operated, and fentanyl requirement were comparable. Complete response to PONV in first 24 hours was observed in 75% (51/68) of children in group G and 76.9% (50/65) of children in group GD, which was comparable statistically (p=0.96, Fisher exact test; OR 1.11, 95% CI 0.50, 2.46). Incidence of PONV between 0 and 24 hours was comparable. One child in group G required rescue antiemetic in first 24 hours and none of the children had severe PONV in group GD. There was no significant difference in incidence or severity of oculocardiac reflex.Conclusion.Dexamethasone did not increase efficacy of granisetron for prevention of PONV in elective pediatric strabismus surgery. Registration number of clinical trial wasCTRI/2009/091/001000.


2002 ◽  
Vol 97 (6) ◽  
pp. 1387-1392 ◽  
Author(s):  
Margarita Coloma ◽  
Paul F. White ◽  
Babatunde O. Ogunnaike ◽  
Scott D. Markowitz ◽  
Philip M. Brown ◽  
...  

Background This study was designed to evaluate transcutaneous electrical acupoint stimulation (acustimulation) using the ReliefBand compared with ondansetron for the treatment of established postoperative nausea and vomiting (PONV) after outpatient laparoscopic surgery. Methods After the authors obtained institutional review board approval and written informed consent, 268 outpatients were enrolled in this randomized, double-blind, placebo- and sham-controlled study. All patients received antiemetic prophylaxis with metoclopramide, 10 mg intravenously, or droperidol, 0.625 mg intravenously, after induction of anesthesia. A total of 90 patients developed PONV in the recovery units and were randomized to one of three treatment groups: (1) the ondansetron group received 4 mg intravenous ondansetron and a sham ReliefBand; (2) the acustimulation group received 2 ml intravenous saline and a ReliefBand; and (3) the combination group received 4 mg intravenous ondansetron and a ReliefBand. A rescue antiemetic (10 mg intravenous metoclopramide) was administered only if the PONV symptoms persisted for 15 min or longer after initiating the treatment. A blinded observer recorded the recovery times, emetic symptoms, rescue antiemetics, maximum nausea scores, complete response to study treatment, and time to achieve discharge criteria. Postdischarge side effects, as well as patient satisfaction and quality of recovery scores, were assessed at 24 and 72 h after surgery. Results The combination group had a significantly higher complete response rate than the acustimulation group (73% vs.40%, P &lt;0.01). In addition, fewer patients (8 vs. 18) in the combination (vs. acustimulation) group experienced subsequent emetic events (P &lt; 0.03). However, there were no significant differences between the three groups with respect to patient satisfaction and quality of recovery scores. Conclusions Acustimulation with the ReliefBand can be used as an alternative to ondansetron for the treatment of established PONV. However, the use of ondansetron (4 mg intravenously) in combination with the ReliefBand device improved the complete response rate to the acustimulation therapy.


2021 ◽  
Vol 8 (01) ◽  
pp. 12-16
Author(s):  
Koilada Shiv Kumar ◽  
Rajan Anand ◽  
Debasis Bagchi

BACKGROUND Postoperative nausea and vomiting are highly prevalent after ophthalmic surgeries in the paediatric age group. In this randomised, double-blind prospective clinical trial, we studied and compared the efficacy of granisetron and combination of granisetron with dexamethasone to prevent postoperative nausea and vomiting after paediatric ocular surgeries. METHODS Sixty paediatric patients (06 - 12 yrs. of age) undergoing elective ocular surgeries were randomly allocated to one of the two groups of 30 patients each. Group (G) received granisetron 40 mcg kg–1 intravenously as a bolus before induction of anaesthesia. Group (G + d) received granisetron 40 mcg kg–1 & dexamethasone 0.1 mg kg–1 intravenously as a bolus before induction. Student t-test, Fisher exact test were used wherever applicable for statistical analysis using SPSS version 15.0. RESULTS A complete response (defined as no post-operative nausea and vomiting and no need for another rescue antiemetic) was achieved in 63.3 % of patients who received granisetron alone and in 96.7 % of patients who received granisetron plus dexamethasone. We found nil difference in complications between the two groups. CONCLUSIONS We found that addition of dexamethasone to granisetron is more effective and beneficial than granisetron alone in preventing postoperative emesis in 1st 24 hours. KEYWORDS Post-Operative Nausea and Vomiting, Anaesthesia, Granisetron, Dexamethasone


2020 ◽  
Author(s):  
Jinwei Xie ◽  
Yingcun Cai ◽  
Jun Ma ◽  
Qiang Huang ◽  
Zongke Zhou ◽  
...  

Abstract Background: Postoperative nausea and vomiting (PONV) after total joint arthroplasty is common and associated with delayed recovery. This study was performed to evaluate the efficacy of three different prophylactic regimens for PONV after total joint arthroplasty under general anesthesia.Methods: Patients undergoing primary total hip or knee arthroplasty were randomized to Group A (8 mg ondansetron), Group B (10 mg dexamethasone plus mosapride), or Group C (three doses of 10 mg dexamethasone plus mosapride). The primary outcome was the incidence of PONV. The secondary outcomes were complete response, rescue antiemetic treatment, opioid consumption, time until first defecation, postoperative appetite score, satisfaction score, length of hospital stay, blood glucose level, and complications.Results: Patients in Group C experienced a lower incidence of severe PONV (1.72%, p<0.001) and a higher incidence of complete response (70.69%, p=0.001) than did patients in Groups A and B. Moreover, less rescue antiemetic treatment and postoperative opioid consumption was needed in Group C (p<0.05). Additionally, a shorter time until first defecation, shorter length of stay, and better postoperative appetite scores and satisfaction scores were detected in patients in Group C. A slight increase in the fasting blood glucose level was observed in Group C, and the complications were comparable among the groups.Conclusion: Prophylactic use of mosapride and three doses of dexamethasone can provide better antiemetic effectiveness, postoperative appetite, bowel function recovery, and pain relief than a single dose or ondansetron only.


2021 ◽  
pp. 72-74
Author(s):  
Anusha K ◽  
Sherin bright

BACKGROUND : Palonosetron is a new potent 5-hydroxytryptamine 3 antagonist. Although used for chemo induced emesis, data is lacking for PONV. The high incidence of nausea and vomiting after breast surgery is well documented. This study compared the effects of i.v.ondansetron and palonosetron administered at the time of induction for preventing postoperative nausea and vomiting (PONV) in these high-risk patients . The aim was to compare Onda METHODS : nsetron 8 mg and Palonosetron 0.075mg administered intravenously for prevention of post operative nausea and vomiting in patients undergoing modied radical mastectomy 24 hours postoperatively, by a randomised , controlled, double blind study. 70 female non smoking patients scheduled for elective modied radical mastectomy were, allocated randomly into 2 groups . Patients received either Palonosetron 0.075mg (GROUP P ) or ondansetron 8mg ( GROUP O ) intravenously, immediately before induction of general anaesthesia. The occurence of nausea, vomiting, retching, need for rescue antiemetics and side effects were monitored for a period of 24 hours after surgery. The compete response rate and overall PONV for 0 - 24 hours were calculated. The demographic prole of the patients were comparable. The RESULTS : incidence of a complete response (no PONV, no rescue antiemetics ) during 0 - 24 hours in post operative period was signicantly high in GROUP P ( 85.7% vs 62.9%, p=0.02) than GROUP O. The incidence of nausea was signicantly low in GROUP P ( 14.3% vs 37.1%). There was no statistically signicant difference between the 2 groups in vomiting, retching, side effects and need for rescue antiemetics. Thus overall PONV was low in GROUP P (14.3% vs 37.1% p = 0.02 statistically signicant.) We conclude that Palonosetron 0.075mg was more effective for preventing PONV in patients undergoing modied radical mastectomy surgery


2017 ◽  
Vol 2017 ◽  
pp. 1-5 ◽  
Author(s):  
Chiaki Murakami ◽  
Nami Kakuta ◽  
Katsuyoshi Kume ◽  
Yoko Sakai ◽  
Asuka Kasai ◽  
...  

Postoperative nausea and vomiting (PONV) occur in 30–50% of patients undergoing general anesthesia and in 70–80% of high PONV risk patients. In this study, we investigated the efficacy of fosaprepitant, a neurokinin-1 (NK1) receptor antagonist, compared to ondansetron, a selective 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist, in moderate to high PONV risk patients from our previous randomized controlled trials. Patients (171 patients from 4 pooled studies) with the Apfel simplified score ≥ 2 and undergoing general anesthesia were randomly allocated to receive intravenous fosaprepitant 150 mg (NK1 group, n=82) and intravenous ondansetron 4 mg (ONS group, n=89) before induction of anesthesia. Incidence of vomiting was significantly lower in the NK1 group compared to the ONS group 0–2, 0–24, and 0–48 hours after surgery (2 versus 17%, 2 versus 28%, and 2 versus 29%, resp.). However, no significant differences in PONV, complete response, rescue antiemetic use, and nausea score were observed between groups 0–48 hours after surgery. In moderate to high PONV risk patients, fosaprepitant decreased the incidence of vomiting and was superior to ondansetron in preventing postoperative vomiting 0–48 hours after surgery.


2010 ◽  
Vol 2 ◽  
pp. CMT.S4016 ◽  
Author(s):  
Jan Wallenborn ◽  
Peter Kranke

On the strength of two phase III clinical trials, palonosetron hydrochloride was granted FDA approval in March 2008 for the prevention of postoperative nausea and vomiting (PONV) in the period up to 24 hours after surgery. Palonosetron is superior to the established first-generation 5-hydroxytryptamin-3 receptor antagonists (5-HT3-RAs) in respect of pharmacokinetic data such as a high receptor binding affinity (pKi = 10.45) and a prolonged mean elimination half-life (40 hours). Clinically, palonosetron 0.075 mg was superior to placebo within the 0 to 24 h period usually investigated. A pooled data analysis of the complete response (CR) rates revealed efficacy in the 0 to 24 h period (when compared to placebo CR = 1.67 [1.38–2.02; P < 0.001, n = 370]) and between 24–72 h after surgery (CR = 1.29 [1.10–1.51; P = 0.002, n = 273]). Overall, the effect of palonosetron in reducing delayed vomiting was not as promising as expected. In the approval studies for PONV the rates of AEs including headache (3%), constipation (2%) and prolongation of the QTc interval (5%) were indistinguishable between palonosetron and placebo. In studies on chemotherapy-induced nausea and vomiting, palonosetron increased the QTc interval (between one and three ms) to a lesser extent than ondansetron or dolasetron (5 ms). The safety profile of palonosetron therefore seems to be favourable so far, making it a preferred perioperative antiemetic in the geriatric population or in multimorbid patients. However, further studies are needed to permit general recommendations, and we still lack comparative trials with older (and less expensive) 5-HT3-RAs, trials with combined PONV prophylaxis, and trials in the paediatric population.


2021 ◽  
Vol 10 (21) ◽  
pp. 4857
Author(s):  
Jiyoung Lee ◽  
In Kyong Yi ◽  
Jung Youn Han ◽  
Eun Duc Na ◽  
Chunghyun Park ◽  
...  

Multimodal prophylaxis for postoperative nausea and vomiting (PONV) has been recommended, even in low-risk patients. Midazolam is known to have antiemetic properties. We researched the effects of adding midazolam to the dual prophylaxis of ondansetron and dexamethasone on PONV after gynecologic laparoscopy. In this prospective, randomized, double-blinded trial, 144 patients undergoing gynecological laparoscopic surgery under sevoflurane anesthesia were randomized to receive either normal saline (control group, n = 72) or midazolam 0.05 mg/kg (midazolam group, n = 72) intravenously at pre-induction. All patients were administered dexamethasone 4 mg at induction and ondansetron 4 mg at the completion of the laparoscopy, intravenously. The primary outcome was the incidence of complete response, which implied the absence of PONV without rescue antiemetic requirement until 24 h post-surgery. The complete response during the 24 h following laparoscopy was similar between the two groups: 41 patients (59%) in the control group and 48 patients (72%) in the midazolam group (p = 0.11). The incidence of nausea, severe nausea, retching/vomiting, and administration of rescue antiemetic was comparable between the two groups. The addition of 0.05 mg/kg midazolam at pre-induction to the dual prophylaxis had no additive preventive effect on PONV after gynecologic laparoscopy.


1970 ◽  
Vol 6 (3) ◽  
pp. 319-328 ◽  
Author(s):  
B Gautam ◽  
BR Shrestha ◽  
P Lama ◽  
S Rai

Background: Postoperative nausea and vomiting (PONV) is a common distressing experience in patients following laparoscopic surgeries. This study was aimed at comparing the efficacies of Ondansetron-Dexamethasone combination with each drug alone as a prophylaxis against PONV in patients after elective laparoscopic cholecystectomy done under general anaesthesia. Materials and methods: Hundred and fifty ASA I and II patients, aged 23 to 65 yrs, were enrolled in this prospective, randomized, double-blind trial to receive one of three treatment regimens: 4 mg Ondansetron (Group O), 8 mg Dexamethasone (Group D) or 4 mg Ondansetron plus 8 mg Dexamethasone (Group OD) (n=50 for each). A standardized balanced general anaesthetic technique was employed. Any episode of PONV and need for rescue antiemetic were assessed at six, 12 and 24 hrs post operation. Complete response was defined as no PONV in 24 hrs and need for rescue antiemetic was considered as failure of prophylaxis. Pain scores, time to first analgesia demand, amount of Meperidine consumption, adverse event(s) and duration of hospital stay were recorded. Results: Complete response occurred in 66.7, 66.0 and 89.4% in Groups O, D and OD respectively. Rescue antiemetics were required in 29.2, 31.9 and 8.5% of patients in Groups O, D, and OD respectively. Significantly high incidence of vomiting and failure of prophylaxis (19.1%) occurred in group D during the first six hrs (P=0.023 versus O & 0.008 versus OD). More frequent antiemetic rescue was required in group O at 6 to 24 hr interval as compared to group OD (P=0.032). Conclusion: Combination of Ondansetron and Dexamethasone is better than each drug alone in preventing PONV after laparoscopic cholecystectomy. Dexamethasone alone is significantly less effective in preventing early vomiting compared to its combination with Ondansetron; whereas Ondansetron alone is less effective against late PONV as compared with combination therapy. Key words: Antiemetic prophylaxis; Dexamethasone; laparoscopic cholecystectomy; Ondansetron; postoperative nausea and vomiting (PONV) doi: 10.3126/kumj.v6i3.1706 Kathmandu University Medical Journal (2008), Vol. 6, No. 3, Issue 23, 319-328


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