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914 result(s) for "metoclopramide"
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The Efficacy of Metoclopramide for Gastric Visualization by Endoscopy in Patients With Active Upper Gastrointestinal Bleeding: Double-Blind Randomized Controlled Trial
INTRODUCTION:The 2021 American College of Gastroenterology Guidelines suggested using of intravenous erythromycin before endoscopy in patients with upper gastrointestinal bleeding (UGIB) to enhance endoscopic view and reduce the need for repeat endoscopy. Evidence on intravenous metoclopramide, which is more accessible, is scant, especially in patients with active UGIB. This study aimed to evaluate the efficacy of metoclopramide for gastric visualization in patients with active UGIB.METHODS:Between April 10, 2021, and October 8, 2022, this double-blind, double-center randomized controlled trial enrolled patients with active UGIB (hematemesis or presence of fresh blood in the nasogastric tube). The eligible patients were randomly assigned in a concealed 1:1 allocation to metoclopramide or placebo. The primary outcome was adequate visualization by objective endoscopic visualized gastroduodenal scores (EVS). Secondary outcomes included mean difference in EVS, duration of esophagogastroduodenoscopy (EGD), immediate hemostasis, need for a second look EGD, units of blood transfusion, length of hospital stay, and 30-day rebleeding rate.RESULTS:Of the 68 eligible patients, 3 of each group were excluded by protocol violation. Finally, 62 patients (31 metoclopramide and 31 placebo) were analyzed. The percentage of patients with adequate visualization in metoclopramide and placebo group was 77.4% and 61.6% (odds ratio [OR] 2.16 [0.71-6.58], P = 0.16). The need for a second look EGD in the 72 hours was lower in the metoclopramide group (3.2% vs 22.6%, OR 0.11 [0.01-0.99], P = 0.02), whereas the other secondary outcomes were not different. However, in gastric lesions subgroup analysis, metoclopramide improved the adequate visualization rate (92.9% vs 50%, OR 13 [1.32-128.10], P = 0.03) and mean EVS at fundus (1.79 ± 0.42 vs 1.29 ± 0.72; P = 0.03).DISCUSSION:Metoclopramide did not improve endoscopic visualization but decreased the need for second look EGD in patients with overall active UGIB. It improved gastric visualization in those with UGIB due to gastric lesions, primarily by improving visualization in the fundus (ClinicalTrials.gov number NCT04771481).
MAGraine: Magnesium compared to conventional therapy for treatment of migraines
Due to the healthcare burden associated with migraines, prompt and effective treatment is vital to improve patient outcomes and ED workflow. This was a prospective, randomized, double-blind trial. Adults who presented to the ED with a diagnosis of migraine from August of 2019 to March of 2020 were included. Pregnant patients, or with renal impairment were excluded. Patients were randomized to receive intravenous magnesium, prochlorperazine, or metoclopramide. The primary outcome was change in pain from baseline on a numeric rating scale (NRS) evaluated at 30 min after initiation of infusion of study drug. Secondary outcomes included NRS at 60 and 120 min, ED length of stay, necessity for rescue analgesia, and adverse effects. A total of 157 patients were analyzed in this study. Sixty-one patients received magnesium, 52 received prochlorperazine, and 44 received metoclopramide. Most patients were white females, and the median age was 36 years. Hypertension and migraines were the most common comorbidities, with a third of the patients reporting an aura. There was a median decrease in NRS at 30 min of three points across all three treatment arms. The median decrease in NRS (IQR) at 60 min was −4 (2–6) in the magnesium group, −3 (2–5) in the metoclopramide group, and −4.5 (2–7) in the prochlorperazine group (p = 0.27). There were no statistically significant differences in ED length of stay, rescue analgesia, or adverse effects. Reported adverse effects were dizziness, anxiety, and akathisia. No significant difference was observed in NRS at 30 min between magnesium, metoclopramide and prochlorperazine.
Promethazine for nausea and vomiting prevention after gynaecological laparoscopic surgery: A randomized controlled trial
Postoperative nausea and vomiting (PONV) represent significant concerns for patients undergoing surgical procedures, as these symptoms greatly impact their postoperative experience. Among female patients undergoing laparoscopic surgery, the incidence of PONV is estimated to be approximately 45%. Moreover, for those individuals who have not undergone preventive treatment, the risk of experiencing PONV can be as high as 80%.Regrettably, despite ongoing efforts, there is still a lack of a fully effective and comprehensive solution to effectively manage and prevent PONV in these patient populations. The pursuit of an ideal strategy for the prevention and management of PONV remains an active area of research and clinical investigation. This prospective, single-center, randomized, double-blind study was conducted at Gansu Provincial Hospital from June 2021 to March 2022, involving a cohort of 100 subjects aged 18–65 years undergoing non-emergent gynaecological laparoscopic surgery. Prior to anesthesia induction, subjects were intravenously administered either 6.25 mg of promethazine or 1 mL of saline. Postoperatively, all subjects received patient-controlled intravenous analgesia and a continuous infusion of metoclopramide at a rate of 50 mg. The primary outcome measures included assessing the incidence of postoperative nausea and vomiting at 72 h following the surgical procedure. The results of this study show that the overall incidence of postoperative nausea and vomiting within 72 h after operation is significantly different between the two groups before. ( P  = 0.026, P  = 0.012). The incidence and severity of nausea during the early period (the first 6 h postoperatively) was significantly different between groups ( P  = 0.043, 95%CI(-0.273,-0.019), P  = 0.048). A statistically significant difference was found in the incidence and severity within 24 h postoperatively ( P  = 0.026,95%CI (-0.348,-0.042), P  = 0.003). Vomiting incidence and severity were lower than in the control group at the 6 h postoperatively but without statistical difference between the two groups ( P  = 0.166, 95%CI(-0.164,0.016) P  = 0.180). Vomiting incidence and severity were statistically different during the 24 h postoperatively ( P  = 0.011, 95%CI(-0.342,-0.048), P  = 0.004). A significant statistical difference was found in the satisfaction between the two groups during the postoperative observation period ( P  = 0.002). The administration of preoperative prophylactic promethazine proved to be notably effective in diminishing both the incidence and severity of postoperative nausea and vomiting within the initial 72 h postoperatively. This intervention demonstrated a favorable safety profile, characterized by a minimal occurrence of adverse effects and an absence of serious adverse reactions. Furthermore, the satisfaction levels of patients undergoing this prophylactic approach were observed to be improved. These findings highlight the potential benefits of preoperative prophylactic promethazine in enhancing the postoperative experience for patients, with positive implications for their overall satisfaction with the surgical procedure.  Clinical Trials Registration Number : (18/12/2021) ChiCTR2100054495.
A multicenter, randomized, double-blind study of ulimorelin and metoclopramide in the treatment of critically ill patients with enteral feeding intolerance: PROMOTE trial
PurposeEnteral feeding intolerance (EFI) is a frequent problem in the intensive care unit (ICU), but current prokinetic agents have uncertain efficacy and safety profiles. The current study compared the efficacy and safety of ulimorelin, a ghrelin agonist, with metoclopramide in the treatment of EFI.MethodsOne hundred twenty ICU patients were randomized 1:1 to ulimorelin or metoclopramide for 5 days. EFI was diagnosed by a gastric residual volume (GRV) ≥ 500 ml. A volume-based feeding protocol was employed, and enteral formulas were standardized. The primary end point was the percentage daily protein prescription (%DPP) received by patients over 5 days of treatment. Secondary end points included feeding success, defined as 80% DPP; gastric emptying, assessed by paracetamol absorption; incidences of recurrent intolerance (GRV ≥ 500 ml); vomiting or regurgitation; aspiration, defined by positive tracheal aspirates for pepsin; and pulmonary infection.ResultsOne hundred twenty patients were randomized and received the study drug (ulimorelin 62, metoclopramide 58). Mean APACHE II and SOFA scores were 21.6 and 8.6, and 63.3% of patients had medical reasons for ICU admission. Ulimorelin and metoclopramide resulted in comparable %DPPs over 5 days of treatment (median [Q1, Q3]: 82.9% [38.4%, 100.2%] and 82.3% [65.6%, 100.2%], respectively, p = 0.49). Five-day rates of feeding success were 67.7% and 70.6% when terminations unrelated to feeding were excluded, and there were no differences in any secondary outcomes or adverse events between the two groups.ConclusionsBoth prokinetic agents achieved similar rates of feeding success, and no safety differences between the two treatment groups were observed.
Formulation development, characterization, and mechanistic PBPK modeling of metoclopramide loaded halloysite nanotube (HNT) based drug-in-adhesive type transdermal drug delivery system
Metoclopramide is an antiemetic agent prescribed for motion sickness, cancer chemotherapy, and pregnancy. The present work aimed to design a metoclopramide-loaded halloysite nanotubes (HNTs) drug-in-adhesive transdermal drug delivery system. Four formulations F1, F2, and F3 with different ratios of HNTs to metoclopramide and a F4 without HNTs were developed using acrylic adhesive DURO-TAK 387–2510 by the solvent casting method. These formulated patches were thoroughly evaluated and in-vitro release and permeation studies were performed. The optimized formulation was analyzed using skin irritation, SEM, DSC, and FTIR studies. The GASTROPLUS TCAT model was used to predict the in-vivo performance. HNT-based formulations exhibited controlled drug release, achieving approximately 60% in 4 h, compared to over 80% release in the same period from the formulation without HNT. The optimized formulation (F3) demonstrated a lag time of 1.802 h with a flux of 0.103 mg/cm 2 /hr. The shelf life was 19.279 months at 5 ± 3 °C. The C max , T max , AUC t , and AUC inf were predicted as 40.84 ng/mL, 6.32 h, 561.51 ng/mL×h and 599.61 ng/mL×h for a 30 mg patch. The study demonstrated that metoclopramide can be effectively loaded into HNTs and proved safe and effective in drug-in-adhesive type transdermal systems using HNTs as a drug carrier.
The use of olanzapine versus metoclopramide for the treatment of breakthrough chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy
Purpose Olanzapine has been shown to be a safe and effective agent for the prevention of chemotherapy-induced nausea and vomiting (CINV). Olanzapine may also be an effective rescue medication for patients who develop breakthrough CINV despite having received guideline-directed CINV prophylaxis. Methods A double-blind, randomized phase III trial was performed for the treatment of breakthrough CINV in chemotherapy-naive patients receiving highly emetogenic chemotherapy (cisplatin, ≥ 70 mg/m 2 or doxorubicin, ≥ 50 mg/m 2 and cyclophosphamide, ≥ 600 mg/m 2 ), comparing olanzapine to metoclopramide. Patients who developed breakthrough emesis or nausea despite prophylactic dexamethasone (12 mg IV), palonosetron (0.25 mg IV), and fosaprepitant (150 mg IV) pre-chemotherapy and dexamethasone (8 mg p.o. daily, days 2–4) post-chemotherapy were randomized to receive olanzapine, 10 mg orally daily for 3 days or metoclopramide, 10 mg orally TID for 3 days. Patients were monitored for emesis and nausea for 72 h after taking olanzapine or metoclopramide. Two hundred seventy-six patients (median age 62 years, range 38–79; 43 % women; Eastern Cooperative Oncology Group (ECOG) PS 0,1) consented to the protocol. One hundred twelve patients developed breakthrough CINV and 108 were evaluable. Results During the 72-h observation period, 39 out of 56 (70 %) patients receiving olanzapine had no emesis compared to 16 out of 52 (31 %) patients with no emesis for patients receiving metoclopramide ( p  < 0.01). Patients without nausea (0, scale 0–10, M.D. Anderson Symptom Inventory) during the 72-h observation period were those who took olanzapine, 68 % (38 of 56), and metoclopramide, 23 % (12 of 52) ( p  < 0.01). There were no grade 3 or 4 toxicities. Conclusions Olanzapine was significantly better than metoclopramide in the control of breakthrough emesis and nausea in patients receiving highly emetogenic chemotherapy.
Promethazine Combined with Metoclopramide for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Colorectal Cancer Surgery: A Randomized Controlled Trial
Postoperative nausea and vomiting (PONV) are undesirable postoperative problems in patients undergoing surgery. However, there is currently no satisfactory solution to this problem. This prospective, single-center, randomized, double-blind, pilot study was conducted at Gansu Provincial Hospital in China. Patients aged 18-65 years who underwent elective colorectal tumor resection were randomly assigned to receive 6.25 mg promethazine or 1 mL saline intravenously before induction of anesthesia. All patients then received postoperative patient-controlled intravenous analgesia and a continuous metoclopramide infusion at 50 mg. The primary endpoint was the incidence and severity of PONV at 6 h, 24 h, 48 h, and 72 h postoperatively. Between June 2021 and March 2022, 96 eligible patients were included in the final analysis, with 48 patients in the promethazine group and 46 in the saline group. The incidence and severity of nausea during the early period (the first 6 hours postoperatively) were significantly different between groups ( = 0.031 and = 0.036). A statistically significant difference was found in the incidence and severity within 24 hours postoperatively ( = 0.023 and = 0.020). The incidence and severity of vomiting were significantly different between groups at 6 h postoperatively ( = 0.043 and = 0.048). Vomiting incidence and severity were statistically different during the 24 hours postoperatively ( = 0.012 and = 0.046). A significant statistical difference was found in the satisfaction between the two groups during the postoperative observation period ( = 0.004). Preoperative prophylactic promethazine significantly reduced the incidence and severity of PONV within 24 hours postoperatively, with few adverse effects and no serious adverse reactions. Additionally, patient satisfaction was also improved.
BAGI-assessed green GC-MS method for rapid analysis of paracetamol/metoclopramide in pharmaceuticals and plasma
The growing demand for eco-friendly and cost-effective analytical methods has driven the development of a fast, green, and sensitive GC-MS assay for the simultaneous quantification of paracetamol (PAR) and metoclopramide (MET) in pharmaceutical formulations and human plasma. Separation was achieved in 5 min using a high-polarity 5% Phenyl Methyl Silox column, with detection at *m/z* 109 (PAR) and 86 (MET). The method was fully validated per ICH guidelines, showing excellent linearity (PAR: 0.2–80 µg/mL, r² = 0.9999; MET: 0.3–90 µg/mL, r² = 0.9988) and precision (tablet recovery: 102.87 ± 3.605% PAR, 101.98 ± 3.392% MET; plasma recovery: 92.79 ± 1.521% PAR, 91.99 ± 2.153% MET). Greenness assessment via three metrics, including the BAGI tool (score: 82.5), confirmed its environmental superiority over conventional methods. With high sensitivity, accuracy, and a 5-minute runtime, this approach is ideal for routine quality control and pharmacokinetic studies.
Effects of ondansetron, metoclopramide and granisetron on perioperative nausea and vomiting in patients undergone bariatric surgery: a randomized clinical trial
IntroductionPost-operative nausea and vomiting (PONV) is a common problem after sleeve gastrectomy. In recent years, following the increase in the number of such operations, special attention has been paid to preventing PONV. Additionally, several prophylaxis methods have been developed, including enhanced recovery after surgery (ERAS) and preventive antiemetics. Nevertheless, PONV has not been completely eliminated, and the clinicians are trying to reduce the incidence of PONV yet.MethodsAfter successful ERAS implementation, patients were divided into five groups, including control and experimental groups. Metoclopramide (MA), ondansetron (OA), granisetron (GA), and a combination of metoclopramide and ondansetron (MO) were used as antiemetics for each group. The frequency of PONV during the first and second days of admission was recorded using a subjective PONV scale.ResultsA total of 130 patients were enrolled in this study. The MO group showed a lower incidence of PONV (46.1%) compared to the control group (53.8%) and other groups. Furthermore, the MO group did not require rescue antiemetics, however, one-third of control cases used rescue antiemetics (0 vs. 34%).ConclusionUsing the combination of metoclopramide and ondansetron is recommended as the antiemetic regimen for the reduction of PONV after sleeve gastrectomy. This combination is more helpful when implemented alongside ERAS protocols.