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Showing 1-20 of 158 trials
NCT07446439
The goal of this study is to measure the effects of using Tradipitant to treat nausea and vomiting induced by GLP-1R agonist use in adults with class I or class II obesity, or adults who are overweight with at least one weight-related condition. The study is placebo-controlled with two treatment arms.
NCT07470619
This randomized clinical trial aimed to evaluate the effectiveness of Twin Hearts Meditation in reducing chemotherapy-induced nausea and vomiting among women with breast cancer undergoing chemotherapy. Chemotherapy-related nausea and vomiting are among the most distressing side effects of cancer treatment and can negatively affect patients' quality of life, nutritional status, and adherence to therapy. The study focused on whether regular practice of this meditation technique could significantly reduce the severity of nausea and the frequency of vomiting episodes following chemotherapy. The main research questions were: Does Twin Hearts Meditation reduce chemotherapy-induced nausea and vomiting among women with breast cancer? Can this complementary and non-invasive intervention be considered a supportive strategy for managing chemotherapy-related symptoms? Participants were randomly assigned to either the intervention group, which practiced Twin Hearts Meditation, or the control group, which received routine care without meditation. The intervention group received a 30-minute guided meditation training session and practiced the meditation three times per week for two weeks. Nausea severity and vomiting episodes were assessed using a nausea severity scale and a vomiting record flow sheet at baseline and at 6, 12, 18, and 24 hours after chemotherapy to evaluate the effectiveness of the intervention.
NCT07456982
The Effect of Relaxation Breathing Exercise on Chemotherapy Induced Nausea and Vomiting in Patients With Hematological Malignancies ABSTRACT Background: Chemotherapy is widely used in the treatment of hematological malignancies despite it has important and difficult side effects in patients. Chemotherapy induced nausea and vomiting are among the most common side effects in patients and antiemetic drugs may not be always curative. Purpose: This research aimed to determine the effectiveness of relaxation breathing exercise on managing chemotherapy induced nausea and vomiting in patients with hematological malignancies undergoing chemotherapy. Method: A randomized controlled trial design was conducted with a total of selected sixty eight patients with hematological malignancies (34 intervention and 34 control participants) undergoing chemotherapy hospitalized in the hematology clinic of a Training and Research Hospital. The intervention group implemented relaxation breathing exercise three times a day with a standard treatment protocol and the control group only received routine drug treatment for chemotherapy induced nausea and vomiting. Nausea and vomiting were assessed by filling Rhodes Index of Nausea Vomiting and Retching (RINVR) for the first six days after the start of the chemotherapy. Results: Data collection process ended. Data analysis process is in progress. Conclusion: In this study the effectiveness of relaxation breathing exercise on chemotherapy related nausea and vomiting will be examined in patients with hematological malignancies. Keywords: Relaxation breathing exercise; Hematological malignancies; Chemotherapy; Nausea and vomiting
NCT07451392
Pylorus-preserving pancreatoduodenectomy (PPPD) is a standard surgical treatment for tumors of the pancreatic head and surrounding areas. However, it is frequently associated with delayed gastric emptying (DGE), a complication that can lead to nausea, vomiting, and prolonged hospital stays. This study is a randomized controlled trial designed to evaluate if a simple intraoperative maneuver (pneumatic balloon dilatation of the pylorus) can reduce the incidence of early postoperative vomiting and DGE. Participants will be randomly assigned to either the intervention group, receiving pyloric dilatation during surgery, or the control group, receiving standard surgery without dilatation. Researchers will monitor postoperative symptoms, gastric emptying function, and overall recovery to determine if this maneuver effectively improves patient outcomes.
NCT02106494
The primary study objective is to demonstrate the superiority of APF530 500 mg given subcutaneously (SC) compared with ondansetron 0.15 mg/kg given intravenously (IV) (up to a maximum of 16 mg) in the delayed-phase (\> 24-120 hours) complete response (CR) rate (defined as no emesis and no use of rescue medications) in subjects receiving highly emetogenic chemotherapy (HEC) as defined by the 2011 ASCO CINV guidelines
NCT07421817
Postoperative nausea and vomiting (PONV) are common and distressing complications following laparoscopic gynecologic surgery. This randomized controlled trial evaluated whether a single preoperative intravenous dose of dexamethasone reduces postoperative vomiting compared with placebo and explored patient-related risk factors associated with PONV. Women undergoing elective laparoscopic gynecologic surgery were randomly assigned to receive dexamethasone (5 mg IV) or placebo at induction of anesthesia. The primary outcome was the incidence of postoperative vomiting within 24 hours, with secondary outcomes including nausea severity, rescue antiemetic use, and postoperative recovery parameters.
NCT07099222
The goal of this clinical study is to improve upon the standard practice of utilizing nerve blocks to enhance the satisfaction of patients undergoing shoulder, or foot and ankle surgery regarding their quality of pain control, the duration of their nerve blocks, as well as the avoidance of opioid medications and subsequently their undesirable side effects. The researchers hypothesize that dexmedetomidine and dexamethasone (Dex-Dex) will work synergistically as adjuncts in a low, non-weight based formula. This would allow the investigators to improve patient satisfaction by providing them with a superior means of pain control that is longer in duration with a decreased probability of unwanted side effects. The proposed clinical study will be a prospective, randomized control trial.
NCT07403370
Olanzapine is an effective antiemetic agent for preventing highly emetogenic regimens-induced nausea and vomiting (HER-INV) in patients receiving highly emetogenic regimens (HER). The optimal dose remains debated, with the standard 10 mg dose often causing significant daytime sedation. Recent evidence suggests that lower doses (2.5 mg and 5 mg) may offer comparable efficacy with improved tolerability. However, no head-to-head randomized controlled trials (RCTs) directly compare all three doses.
NCT06772519
The goal of this clinical trial is to investigate the effectiveness of colored (green and blue lens) glasses as a non-pharmacological method in relieving post-surgical pain and postoperative nausea in kidney donors. The main hypothesis it aims to test: H1: Postoperative use of green-lensed glasses by patients who are kidney donors is effective in relieving surgical pain and postoperative nausea. H2: Postoperative use of blue-lensed glasses by patients who are kidney donors is effective in relieving surgical pain and postoperative nausea. Researchers will compare the blue-lens glasses and green-lens glasses groups to the transparent (colorless) glasses group and the non-glasses group to see if the colored lenses have an effect on postoperative pain and nausea. Participants in the intervention groups will be asked * to wear the glasses (according to their randomly assigned group (blue/green/colorless/), immediately after they admitted to the ward postoperatively, at least 8 hours in a day, until their discharge * to respond the pain and nausea assessment (every 2 hours during postop day 1 and every 4 hours during postop day 2) until their discharge Participants in the control group will be asked \- to respond the pain and nausea assessment (every 2 hours during postop day 1 and every 4 hours during postop day 2) until their discharge
NCT06326983
This is a prospective, randomized, controlled, non-inferiority study of patients undergoing tonsil surgeries at Boston Children's Hospital Waltham. The overall aim is to evaluate the efficacy of an opioid anesthetic plan (morphine, ketorolac, and acetaminophen versus an opioid sparing anesthetic plan (dexmedetomidine, ketorolac and acetaminophen) for perioperative analgesia and recovery time in patients undergoing tonsillectomies and tonsillotomies at Boston Children's Hospital Waltham. Secondary measures include rescue opioids administered in post-anesthesia care unit (PACU), re-operation secondary to bleeding, emergence delirium, post-operative nausea and vomiting, intraoperative hemodynamics, intraoperative vasopressor administration, and length of procedure.
NCT07315412
This randomized controlled clinical trial aims to evaluate the effectiveness of chewing gum with different natural flavors in reducing postoperative nausea and vomiting (PONV) following Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC). Adult patients undergoing PIPAC will be randomly assigned to one of three groups: (1) ginger-mint flavored gum, (2) cinnamon flavored gum, or (3) control group with standard postoperative care only. Participants in the intervention arms will chew one piece of gum for 15 minutes in the post-anesthesia care unit (PACU). Nausea intensity (Numeric Rating Scale, 0-10) and the presence of vomiting or retching will be assessed at baseline and every 15 minutes for 2 hours. The study hypothesizes that ginger-mint and cinnamon flavored chewing gums, both plant-based and certified vegan, will be effective, non-pharmacological, and safe methods to reduce nausea and vomiting after PIPAC. This research may contribute to enhanced postoperative comfort and faster recovery by supporting the principles of Enhanced Recovery After Surgery (ERAS).
NCT07274215
This single-center, prospective, randomized, double-blind controlled trial aims to evaluate the effects of intraoperative paragastric block (PGBLOCK) on early postoperative visceral pain, postoperative nausea and vomiting (PONV), and analgesic requirements in patients undergoing laparoscopic sleeve gastrectomy (LSG). Despite advancements in multimodal analgesia protocols, visceral pain remains a significant postoperative concern following LSG, contributing to increased opioid use and delayed recovery. Paragastric block is a novel technique targeting autonomic neural pathways-such as branches of the celiac ganglia and vagal nerves-through precise intraoperative injection of local anesthetics near the stomach. A total of 180 patients scheduled for elective LSG will be randomized in a 1:1 ratio to receive either paragastric block with 20 mL of 0.5% bupivacaine or a sham block with 20 mL of isotonic saline. Injections will be administered at six predefined anatomical sites under laparoscopic guidance after gastric resection. The surgical technique, anesthetic protocol, and postoperative care will be standardized for all participants. Both patients and clinical personnel involved in care and outcome assessment will remain blinded to group assignment. The primary outcome is the assessment of postoperative visceral pain using Visual Analog Scale (VAS) scores at 0 and 2 hours postoperatively. Secondary outcomes include PONV severity grading, mobilization status, total analgesic consumption (pethidine + tramadol), and need for rescue antiemetics within the first 24 hours post-surgery. Exclusion criteria include history of upper abdominal surgery, chronic opioid use, pregnancy, severe systemic disease, or allergy to medications used in the protocol. This study is expected to provide high-quality evidence regarding the efficacy of paragastric block in improving early postoperative recovery and reducing opioid reliance after LSG.
NCT06632184
Brief Summary Background: Laparoscopic cholecystectomy is a common procedure where postoperative pain and nausea/vomiting (PONV) remain significant issues, impairing recovery. Standardized multimodal analgesia (e.g., PROSPECT guidelines) is effective for pain, but PONV incidence stays high. Preliminary evidence suggests that adding ondansetron to the standard intraperitoneal saline lavage could provide additional analgesic and antiemetic benefits by blocking peripheral 5-HT3 receptors at the trauma site. Objective: This pilot study aims to evaluate if intraperitoneal lavage with saline + 8mg ondansetron reduces the total burden of postoperative pain over the first 24 hours (Area Under the Curve of the Visual Analog Scale, AUC-VAS/24h) compared to saline lavage alone, within a standardized multimodal protocol. Methods: This is a phase IV, pilot, randomized, controlled, triple-blind clinical trial. 40 adult patients (ASA I-II) undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis (Nassar Grade I-II difficulty) will be randomly assigned (1:1) to: Control Group: 500 ml of 0.9% saline intraperitoneal lavage. Intervention Group: 500 ml of 0.9% saline + 8 mg ondansetron intraperitoneal lavage. The lavage is performed for 5 minutes at the end of surgery, followed by complete aspiration. All patients receive a strict multimodal perioperative protocol, including pre-incisional port site infiltration with bupivacaine 0.75%, standardized anesthesia, and postoperative analgesics. The use of intravenous ondansetron is prohibited to avoid confounding. Primary Outcome: Total postoperative pain burden (AUC-VAS/24h). Secondary Outcomes (Exploratory): PONV incidence; time to first rescue analgesia; rescue analgesic consumption (buprenorphine); postoperative sleep quality (Richards-Campbell Sleep Questionnaire); safety and adverse events.
NCT07271147
To explore the effects and possible mechanisms of dexmedetomidine combined with taVNS on the incidence of postoperative nausea and vomiting in female patients undergoing laparoscopic surgery
NCT06554184
This study is aimed to evaluate the efficacy and safety of HR20013 versus palonosetron for nausea and vomiting associated with moderate emetic risk anticancer agents
NCT07201883
The proposed randomized clinical trial aims to test and compare the efficacy of chewing gum vs. Intravenous antiemetic ondansetron as rescue treatment for post-operative nausea and vomiting (PONV) among Lebanese female patients undergoing laparoscopic surgery in the post-operative anesthesia care unit (PACU).
NCT06997419
Dexamethasone is almost one of the most commonly used drugs for postoperative nausea and vomiting (PONV) prevention. However, PONV is still a complex problem to be solved; for example, even with preoperative dexamethasone administration, there are still some patients still experience PONV within 24 hours postoperatively. Compared to dexamethasone, dexamethasone palmitate has a long-lasting anti-inflammatory effect, 2-5 times that of traditional water-soluble dexamethasone, with fewer adverse effects. This trial aims to assess the effect and safety of preoperative dexamethasone palmitate on PONV after open surgery.
NCT03413371
The aim of this randomized trial is to assess the efficacy of preventive analgesia using different peribulbar blocks (PBB) under SPI-guided anaesthesia for vitreoretinal surgery (VRS), presence of PONV (postoperative nausea and vomiting) and oculocardiac reflex (OCR) and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception postoperatively. Patients will receive general anaesthesia combined with either preventive PBB using either lidocaine with bupivacaine or bupivacaine or ropivacaine
NCT06937684
This study investigates the safety and tolerability of early oral clear fluid intake in children aged 1-8 years undergoing elective outpatient non-gastrointestinal surgeries. Patients will be randomized to receive clear fluids either at 1 hour or 2 hours after general anesthesia. The goal is to determine whether earlier fluid intake increases the risk of postoperative vomiting (POV), or whether it can be safely tolerated in pediatric patients."
NCT06887621
Amisulpride is a potent antagonist of dopamine D2 and D3 receptors, both implicated in the emetic response when activated. It is currently used intravenously for the prevention of chemotherapy-induced and postoperative nausea and vomiting (PONV), but this route has a short half-life time of 4 to 5 hours, could be expensive, causes infusion-related pain, and is not available in Brazil. Some of these limitations could be overcome by the preemptive use of an oral formulation. At present, there are no data regarding the use of oral amisulpride for PONV, which is an affordable and painless option with half-life time of 12 hours. We propose a quadruple-blind clinical trial involving patients undergoing gynecological surgery aged 18 years and older, and assessed as being at high risk for PONV according to the Apfel Score (score 3 or 4). The primary outcome of this study is to evaluate complete response to PONV up to 24h, comparing the efficacy of adding 50 mg oral amisulpride as a third antiemetic agent to the standard institutional protocol at the Hospital da Mulher of São Paulo (IV dexamethasone 10 mg + IV ondansetron 4 mg) for laparoscopic surgeries. Secondary outcomes will evaluate (1) nausea, (2) vomiting, (3) nausea and vomiting, (4) use of rescue treatment, (5) overall adverse events, and (6) adverse events.