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Vomiting clinical trials

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NCT ID: NCT03204279 Completed - Clinical trials for Chemotherapy-induced Nausea and Vomiting (CINV)

PK/PD Study of Netupitant and Palonosetron in Pediatric Patients for Prevention of Chemotherapy-induced Nausea and Vomiting

CINV
Start date: August 31, 2017
Phase: Phase 2
Study type: Interventional

This study is Phase 2 pharmacokinetic (PK) and pharmacodynamic (PD) dose-finding study of oral netupitant administered concomitantly with oral palonosetron in pediatric cancer patients for the prevention of nausea and vomiting associated with emetogenic chemotherapy. Two different netupitant dosages will be tested in patients aged from 3 months to < 18 years: 1.33 mg/kg up to a maximum of 100 mg, and 4 mg/kg up to a maximum of 300 mg. All netupitant doses in all age classes will be concomitantly administered with palonosetron 20 μg/kg (up to a maximum dose of 1.5 mg) which is the IV palonosetron dose approved by USA FDA for the pediatric population. The primary objective is to investigate the PK/PD relationship between netupitant exposure (AUC, Cmax) and antiemetic efficacy (CR in delayed phase) after a single oral netupitant administration, concomitantly with oral palonosetron in pediatric cancer patients receiving Moderately Emetogenic Chemotherapy (MEC) or Highly Emetogenic Chemotherapy (HEC) cycles. Efficacy parameter to be used in the correlation is the proportion of patients with Complete Response (CR i.e., no emetic episodes and no rescue medication) during (> 24-120 h after the start of chemotherapy on Day 1). The secondary objectives are to assess the safety and tolerability after single oral administration of netupitant given concomitantly with a single oral administration of palonosetron; to evaluate the pharmacokinetic (AUC, Cmax, tmax and t1/2) of oral palonosetron at the fixed dose of 20 μg/kg in pediatric patients with the concomitant administration of netupitant. A total of 92 pediatric cancer patients receiving either HEC or MEC will be enrolled in the study.

NCT ID: NCT03202459 Recruiting - Clinical trials for Postoperative Complications

Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery

Start date: March 2, 2017
Phase: N/A
Study type: Interventional

Postoperative nausea and vomiting (PONV) is one of the most commonly reported adverse effects of anesthesia. The general incidence of vomiting is approximately 30%, nausea at 50% and the PONV rate can go up to 80% in high-risk patients without prophylaxis. Prevention of these episodes in high-risk patients improves satisfaction and well-being rates. Therefore, it becomes important the adequate control of PONV, aiming at the satisfaction of the patient with the procedure, lower costs for the health system as well as reduction of complications in the postoperative period. This study aims to evaluate the association of gabapentin or pregabalin with dexamethasone in reducing the incidence of PONV in high-risk patients undergoing laparoscopic surgeries in the first 48 hours postoperatively as well as to assess side effects.

NCT ID: NCT03195322 Completed - Breast Cancer Clinical Trials

Pre-pectoral AlloDerm® to Reinforce Tissues in Tissue Expander Breast Reconstruction

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

Primary Objective: • To describe postoperative static pain scores on the Pain Visual Analog Scale at Day 1 in a population of women undergoing bilateral mastectomy followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction reinforced with AlloDerm® coverage. Secondary Objectives: - To describe postoperative static and dynamic pain scores on the Pain Visual Analog Scale and Brief Pain Inventory-Short Form at Day 1-60 after tissue expander placement - To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after mastectomy and tissue expander placement. - To describe short-term changes in Quality of Life scores after mastectomy and tissue expander placement. - To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after mastectomy and tissue expander placement. - To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant. - To describe short-term changes in Quality of Life scores after final reconstruction with tissue expander exchange for permanent implant. - To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant. - To describe postoperative rates of breast animation deformity at Day 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant. - To describe average hospital length of stay in patients after final reconstruction with tissue expander exchange for permanent implant. - To describe the patient's final assessment of pre-pectoral reconstruction from free-form text. Tertiary Objectives: • To measure cosmetic result and associated residual pain with Alloderm® reinforcement of breast pocket.

NCT ID: NCT03187080 Suspended - Opioid Use Clinical Trials

Enhanced Recovery Strategies in Elective Breast Surgery

Start date: April 2024
Phase: Phase 4
Study type: Interventional

Postoperative pain, nausea, and vomiting are frustrating sequelae of elective breast surgery. Poorly managed postoperative pain can lead to increased opioid use, increased postoperative nausea and vomiting (PONV), delayed return to work and usual activities, unplanned hospital admissions, surgical complications, and patient dissatisfaction. In light of the growing opioid epidemic in the United States, any intervention that potentially minimizes opioid use may have meaningful individual and societal impact. In patients undergoing breast reduction and breast augmentation surgery, multiple techniques for managing postoperative pain are used commonly. One such technique is the use of a paravertebral block (PVB), which is a method of injecting local anesthesia into the area surrounding the spinal nerves in order to decrease sensation and pain in the chests and breasts in the setting of breast surgery. PVB is generally used concomitantly with standard multimodal perioperative pain management including cool compress, non-steroidal anti-inflammatories (NSAIDs), acetaminophen, and opioids. All of these pain management strategies are used at the University of Wisconsin and are considered standard of care for breast surgery nationwide. The overall purpose of this study is to evaluate interventions that aim to optimize pain control, minimize the risk of PONV, and improve recovery after elective breast surgery. We will do this by (1) Comparing PVB with standard pain management strategies in patients undergoing planned breast reduction and breast augmentation, and (2) Comparing "enhanced recovery after surgery" (ERAS) strategies to standard of care for patients undergoing planned breast reduction and breast augmentation. This will be studied using pain assessments, validated surveys, medication logs, and review of medical records.

NCT ID: NCT03185156 Completed - Nausea and Vomiting Clinical Trials

The Preventive Effects of Sub Hypnotic Dose of Propofol for Nausea and Vomiting Induced by Hemabate

Start date: June 28, 2017
Phase: Phase 4
Study type: Interventional

This is a randomized, placebo-controlled trail, the objective of this study is observation the effect of sub hypnotic dose of propofol for prevention of nausea and vomiting induced by hemabate during spinal anesthesia for elective cesarean section. The primary outcome is the presence of post-delivery intra-operative nausea and vomiting in parturients. The patients demographic characteristics, blood pressure, sensory block level, and the medications will be collected.

NCT ID: NCT03178058 Recruiting - Clinical trials for Postoperative Nausea and Vomiting

Risk Factors for Postoperative Nausea, Vomiting and Pruritus

Start date: October 2016
Phase: N/A
Study type: Observational

In this study we would like to identify demographic and individual risk factors that place parturients at a higher risk for postoperative nausea and vomiting (PONV) and itching following administered neuraxial morphine for cesarean section. Our primary objective is to develop a reliable predictive neuraxial morphine induced nausea and vomiting (NMINV) and itching model.

NCT ID: NCT03171688 Completed - Clinical trials for Postoperative Nausea and Vomiting

Risk Factors for Nausea and Vomiting After Cesarean

Start date: May 1, 2016
Phase:
Study type: Observational

Investigators will observe the incidence of post-cesarean nausea or vomiting and try to associate it with some risk factors.

NCT ID: NCT03165123 Not yet recruiting - Clinical trials for Post-operative Nausea and Vomiting

Effect of Using Azithromycin Versus Placebo With Dexamethasone in Prevention of Post-spinal Nausea and Vomiting.

Start date: June 1, 2019
Phase: Phase 4
Study type: Interventional

Postoperative nausea and vomiting is defined as any nausea, retching, or vomiting occurring during the first 24-48 h after surgery in inpatients. Postoperative nausea and vomiting is one of the most common causes of patient dissatisfaction after anesthesia, with reported incidences of 30% in all post-surgical patients and up to 80% in high-risk patients. In addition, postoperative nausea and vomiting is regularly rated in preoperative surveys, as the anesthesia outcome the patient would most like to avoid. While suture dehiscence, aspiration of gastric contents, esophageal rupture, and other serious complications associated with postoperative nausea and vomiting are rare, nausea and vomiting is still an unpleasant and all-too-common postoperative morbidity that can delay patient discharge from the post-anesthesia care unit and increase unanticipated hospital admissions in outpatients.

NCT ID: NCT03143829 Completed - Neoplasms Clinical Trials

Promoting Cancer Symptom Management in Older Adults

Start date: August 11, 2016
Phase: N/A
Study type: Interventional

The purpose of the project is to estimate the effect size of a technology based intervention for older adults with cancer for nausea and vomiting. Participants will be randomized to either an intervention or a wait control group. Outcomes such as symptom severity, quality of life and resource use will be examined.

NCT ID: NCT03142464 Completed - Clinical trials for Postoperative Nausea

Intravenous Fluids After Laparoscopic Cholecystectomy

Start date: July 1, 2015
Phase: N/A
Study type: Interventional

Perioperative intravenous fluid (IV) administration has been the standard procedure since 1832 and, is a widely used practice sometimes under inadequate criteria. The present work aims at verifying the clinical need that justifies the common IV fluid prescription on the postoperative (PO) period in patients undergoing videolaparoscopic cholecystectomy (CVL) elective.