Immune System Diseases

All Conditions

Hypersensitivity

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Anti-Infective Agents

Paclitaxel

Dexamethasone

Albumin-Bound Paclitaxel

Dexamethasone acetate

BB 1101

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Dexamethasone 20 mg (4 mg/tablet) or 5 tablets given orally at 12 and 6 hours before paclitaxel infusion and 0.9% NaCL (Placebo) 4 ml given intravenously at 30 minutes before paclitaxel infusion

Lactose (Placebo) 5 tablets given orally at 12 and 6 hours before paclitaxel infusion and dexamethasone 20 mg (5mg/ml) given intravenously at 30 minutes before paclitaxel infusion

Intravenous Dexamethasone

Oral Dexamethasone

Dr Marut Yanaranop, MD

Comparison of the efficacy and side effects of intravenous and oral regimens of dexamethasone for prophylaxis of paclitaxel-associated hypersensitivity reactions in primary ovarian, fallopian tube and peritoneal cancer patients receiving first cycle of combination paclitaxel and carboplatin.

The consensus statements on the management of ovarian cancer recommended intravenous paclitaxel (175 mg/m2 over 3 hr) plus intravenous carboplatin (area under the curve \[AUC\] 5.0-7.5 mg/ml∙min) given every 3 weeks for six cycles for first-line chemotherapy. A major limitation of paclitaxel was its poor water solubility, which led to the use of polyoxyethylated castor oil vehicle or Cremophor® EL as diluents resulted a hypersensitivity reactions (HSRs). Initial P-HSRs generally occur within 10 minutes of the start of paclitaxel infusion and most occur with the first or second infusion. Majority of patients manifest as minor symptoms characterized by flushing and rashes but sometime life-threatening characterized by generalized urticaria, angioedema, bronchospasm and hypertension or until fatal may occur. The reaction is likely due to the release of histamine and other vasoactive substances in response to Cremophor EL. Originally, the prophylactic regimen composed of the use of an oral corticosteroid administered in two doses at 12 and 6 hours prior to paclitaxel infusion accompanied with histamine receptor H1 and H2 antagonists administered intravenously 30 minutes prior to paclitaxel infusion was found to successfully limit P-HSRs denoted as "Conventional oral prophylactic regimen".

While this three-drug prophylactic regimen has been shown to be effective, it can be inconvenient for patients because the oral corticosteroid must be taken 12 and 6 hours before chemotherapy administration. If the patient forgets to take one or both pretreatment steroid doses, it is not clear whether the patient can be safely treated. This led to the experimental prophylactic regimen of one dose of intravenous dexamethasone accompanied with the H1 and H2 antagonists administered 30 minutes prior to paclitaxel infusion was subsequently reported to be equivalent to the regimen of oral dexamethasone denoted as "Modified intravenous prophylactic regimen". This intravenous regimen results in lower total steroid doses and precludes the issues of compliance.

Dexamethasone Regimens for Prophylaxis of Paclitaxel-associated Hypersensitivity Reaction

Intravenous Versus Oral Regimens of Dexamethasone for Prophylaxis of Paclitaxel-associated Hypersensitivity Reaction in Primary Ovarian, Fallopian Tube and Peritoneal Cancer Patients: a Double-blind Randomized Controlled Trial

The participants are received either intravenous dexamethasone or placebo (0.9% NaCL) at 09.30 am (30 minutes before paclitaxel infusion) depend on intervention groups. Intravenous ranitidine 50 mg and diphenhydramine 50 mg are also given all participants. Paclitaxel is started at 10.00 am by the calculated dose of is diluted in 500 ml of saline and administered by intravenous infusion over 3 hours.

All participants receive the personal logbook for self-administration of side effects from dexamethasone in day 1-7

The adverse events are collected according to NCI CTCAE version 4.03.

Chulalongkorn University

Rajavithi Hospital

Neoplasms

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Adenoma

Pain

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stomach Cancer

Sucralfate

Lansoprazole

Dexlansoprazole

Proton Pump Inhibitors

To receive intravenous dexamethasone (0.15 mg/kg) immediately after ESD

To receive normal saline as placebo intravenous immediately after ESD

Patients were enrolled in outpatient settings after evaluating appropriate ESD indications. A single study coordinator performed a randomization process by using a table of random numbers. The patients were allocated to receive intravenous dexamethasone (0.15 mg/kg) immediately after ESD. The patients with an odd number were assigned into DEXA group, and the patients with an even number were assigned into placebo group. The syringe including dexamethasone was completely covered with a paper sticker to mask treatment assignment. The operator and assisting nurse were also blinded to the study.

At the day and next day of ESD, intravenous proton pump inhibitor was routinely administered to prevent complications including bleeding. At 3rd day of ESD, all patients started to take 40mg oral lansoprazole once a day and sucralfate suspension 3 times a day for 28 days.

intravenous dexamethasone

Patients were enrolled in outpatient settings after evaluating appropriate ESD indications. A single study coordinator performed a randomization process by using a table of random numbers. The patients were allocated to receive intravenous normal saline as placebo immediately after ESD. The patients with an odd number were assigned into DEXA group, and the patients with an even number were assigned into placebo group. The syringe including placebo was completely covered with a paper sticker to mask treatment assignment. The operator and assisting nurse were also blinded to the study.

At the day and next day of ESD, intravenous proton pump inhibitor was routinely administered to prevent complications including bleeding. At 3rd day of ESD, all patients started to take 40mg oral lansoprazole once a day and sucralfate suspension 3 times a day for 28 days.

intravenous normal saline

Hyuk Lee, MD

Besides major ESD-related complications, minor adverse events after ESD are also commonly noticed. Pain is one of minor ESD-related complications. . The causes of pain associated with ESD or gastric polypectomy are thought to be associated with transmural burn or transmural air leak. How control localized pain for patients who suffered from pain after ESD is appearing as new medical interests. There are few studies about management strategy for pain after ESD. Glucocorticoids are used to reduce inflammation and tissue damage in various clinical settings including inflammatory disease, rheumatic disease, and so on. The efficacy of glucocorticoids for reducing pain after surgery has recently been investigated. Glucocorticoids are thought to locally inhibit collagen deposition and fibrosis and finally reduce scar-tissue formation. Especially systemic steroids are easy to achieve a continuous effect through stable serum concentrations. If pain was partially associated with acute inflammation, we assumed intravenous dexamethasone could be helpful to relieve pain after ESD based on previous studies. we aimed to assess the efficacy of single dose postoperative intravenous dexamethasone for pain relief after ESD.

Pilot Trial on Efficacy of Single Dose Perioperative Intravenous Dexamethasone for Pain Relief After Endoscopic Submucosal Dissection

The primary outcomes of this study was present pain intensity (PPI) measured at 6 hours after ESD. The reason for adopting 6- hour PPI as primary endpoint was due to maximized pain at 6 hours after ESD in our pilot study.

Yonsei University

Respiratory Tract (Lung and Bronchial) Diseases

Respiration Disorders

Respiratory Tract Diseases

patients receive one single dose of intravenous dexamethasone 8 mg.

patients receive one single dose of intravenous placebo.

One dose of intravenous dexamethasone (8 mg) 60 minutes before surgery.

Patients of the control group received homologated placebo 60 minutes before surgery.

intravenous salin water

González-Ojeda Alejandro, PhD. MD.

Preoperative dexamethasone reduces symptoms after different surgical procedures including mastectomy in breast cancer, but the effect in the postoperative respiratory function remains unknown. The aim of this protocol was to determine if the administration of a single dose of dexamethasone during the preoperative, could improve respiratory function and postoperative symptoms of patients undergoing mastectomy in breast cancer.

Controlled clinical trial will be performed in 120 surgical patients treated for breast cancer, conducted from Nov 2014 to Nov 2015. Patients will be divided in three groups: Group 1 consisted in patients who underwent conservative breast with axillary lymph node dissection, group 2 in patients with radical mastectomy without reconstruction, and group 3 patients with radical mastectomy with immediate reconstruction with synthetic breast implants.

All patients will be randomly assigned by a system of sealed envelopes, to receive 8 mg of intravenous dexamethasone or placebo 60 minutes before surgery. All patients will be female and had a confirmed diagnosis of breast carcinoma. The investigators will exclude patients with a classification of the American Society of Anesthesiologists classes III and IV. Other exclusion criteria are: age 80 years, pregnancy or during menstruation, during steroid therapy, severe diabetes mellitus (serum HbA1c\> 8%); opioids, sedatives or painkillers less than a week before the mastectomy, or a history of alcohol or drugs. The investigators will exclude patients with a history of inner ear disease and / or severe PONV after any surgical procedure performed in the past. All patients will be admitted to hospital one day before surgery and were followed from hospital admission and until 30 days after surgery for any medical or surgical morbidity.

Anesthesia and surgery

All patients will be standardized to the next anesthetic protocol:

Under venipuncture, patients receive 1 g of Cephalothin IV one hour before starting the procedure. After entering the operating room, type 1 continuous monitoring was placed via noninvasive, Midazolam will be administered via peripheral 0.1-0.2 mg/kg as well as fentanyl 1 mcg / kg IV. Prongs will be placed and basal hemodynamic values will be taken with preoxygenation by tidal volume technique per minute.

Induction will be performed with Propofol 1-2 mg/kg IV and completed with fentanyl (3 mcg / kg IV) along with the administration of Rocuronium 0.06 mg/kg IV. Assisted oxygenation continues at a rate of 5 lpm and laryngeal mask (mask measure according to weight and body distribution of the patient) is placed.

During surgery, the medication will be completed with omeprazole 40 mg IV, Ondancetron 4 mg IV. All patients will be monitored with indirect determinations of blood pressure and heart rate using standard techniques, as well as the content of expired CO2 and oxygen saturation of the blood. Subsequently, all patients will be extubated and transferred to the unit for immediate post-surgical care with cardiovascular monitoring and oxygen.

Surgical Procedures All patients will be submitted to treatment according to the clinical stage with conservative breast surgery with axillary dissection, radical mastectomy without immediate reconstruction or radical mastectomy with immediate reconstruction with synthetic implants. In case of radical mastectomy, a closed drainage system will be placed in the chirurgic region, and will be removed when drainage is less than 50ml in 24 hours. Chemotherapy or radiation therapy will be administered 3-4 weeks following surgical resection.

Analgesic and antiemetic therapy Nonsteroidal antiinflammatory drugs will be used as analgesia after surgery with sodium ketorolac 30 mg IV every 6 hours (in patients younger than 60 years) or lysine Clonixinate 100 mg IV every 6 hours (in patients older than 60 years). Also, patients who will be submitted to a conservative surgery will receive intravenous Tramadol 100mg (diluted in 50ml of solution); the dose may be repeated every 12 hours until. Repeated doses of Morphine of 2.5 mg IV will be used in case of radical mastectomy, according to the needs of the patient. If pain is not diminish within 30 minutes a VAS will be used and in case the scale is greater than 7, an infusion of 10mg of morphine in 250ml 0.9% of saline solution will be used. Pain will be assessed on return to the recovery room and at 6, 12 and 24 h postoperatively using a visual analogue scale (VAS; 0 = no pain and 10 = most severe pain).

The incidence of PONV will be recorded immediately on return to the recovery room and at 6, 12 and 24 h postoperatively using a three-point ordinal scale (0 = asymptomatic, 1 = feeling of nausea or tonnage without expulsion oral route of gastric contents 2 = vomiting). Nausea is defined as a unpleasant sensation associated with awareness of the urge to vomit; retching is defined as the labored, spasmodic rhythmic contraction of the respiratory muscles without the expulsion of gastric contents, and vomiting is defined as the forceful expulsion of gastric contents from the mouth. Ondancetron will be used IV (4-8 mg) to treat these symptoms.

Pulmonary Function. To perform a spirometry, the ambient must comply the following characteristics: environment without audio or visual shocks and thermal comfort for the comfort of the patient. Patients will be told to sit in a comfortable position with your back straight (at an angle greater than 45°, to patient tolerance) and high chin. Lightweight support will be perform in the patient by taking her gently by the shoulders to keep them lean forward and off balance grew. In the immediate postoperative and due to postoperative pain, the patient will be settled in the stretcher to emulate the sitting position (inclination greater than 45 °) performing the previously mentioned subject. The nature of the study will be explained in understandable language to the patient, and their cooperation will be requested. Forced espiratory maneuver will be explained and immediately exemplified by the best qualified to understand the patient and to avoid measurement bias evaluator. Special emphasis will be placed on the importance of starting the effort with the maximum volume of air in the lungs, so determined and energetic, as well as maintaining exhalation as long as possible. She will be asked to take the disposable cardboard mouthpiece adaptable to pneumotachograph, sealing it with the lips in the position of maximal inspiration and then blow air through it, initiating a sharp exhalation maneuver with the above characteristics. To be a valid test, the maneuver should be performed with a proper effort, starting from the position of maximal inspiration without hesitation or false start with a continuous exhalation without corrections, cough or Valsalva maneuver, as well as checking for leaks were recorded in nozzle. A total of three satisfactory maneuvers will be performed with a maximum of eight attempts for each measurement, spaced at least for 30 seconds. To perform the study, a "Fleisch spirometer" with brand Sibelmed® neumotac type model will be used Datospir 110/120.

Measurements of forced espiratory volume in one second (FEV1), forced vital capacity (FVC) Maximum Forced Espiratory Flow (FEFM) and the ratio between forced espiratory volume in one second and forced vital capacity will be taken into account (FEV1 / FVC). Such clinical parameters are directly related to muscle fatigue, the compliance of the lung parenchyma and respiratory status of patients.

Statistical Analysis Postoperative complications will be recorded during hospitalization and patients will be followed up to 30 days after hospital discharge. Data collected will include patient age, body mass index (BMI), smoking history and neoadjuvant chemotherapy, anesthesia and operation time and the frequency of use of analgesics and antiemetics. These parameters will be added and compared between dexamethasone and placebo groups. The endpoints of the study will be postoperative nausea and vomiting, and pain measured by the VAS and the need for additional analgesia and antiemetic drugs as described.

The sample size was predetermined. The investigators expect a 35% difference in the incidence of nausea and vomiting between groups. The α error 0.05 and β error 0.20; n = 35 patients in each group will be considered adequate, according to an analysis of power. All results eill be expressed as percentages and means with standard deviation ± (SD). Student t test, Chi 2 of Fisher's exact test will be used to analyze quantitative and qualitative data, respectively. Differences will be considered statistically significant at p \<0.05.

Ethical Considerations This protocol has been registered with the Local Research and Ethics Committee on Health.

The study will be conducted according to the principles of the Helsinki Declaration of 1989, and with the Guidelines of Health of Mexico. The local research and ethics committee of Health Research Ethics Committees of the Cancer Institute of Jalisco, Mexico approved all protocols. A full written informed consent will be obtained from all patients before inclusion in the study.

Dexamethasone and Respiratory Function After Mastectomy

Effect of the Preoperative Administration of Dexamethasone in the Respiratory Function and Postoperative Symptoms in Women Undergoing Mastectomy for Cancer. Results of a Randomized Clinical Trial.

maximum amount of air a person can expel from the lungs after a maximum inhalation.

Measures the amount of air a person can exhale during a forced breath in one second.

An unpleasant sensation occurring in varying degrees of severity as a consequence of injury, disease, or emotional disorder.

Nausea is the feeling of having and urge to vomit. It is often called being sick to your stomach.

Vomiting is forcing the contents of the stomach up through the esophagus and out of the mouth.

Total dose of backup analgesic medication will be recorded during the last 24 hours after the surgical procedure.

Total dose of backup antiemetic medication will be recorded during the last 24 hours after the surgical procedure.

The prevalence of a disease in a particular percentage of the population; the number of cases of a particular disease per unit of population.

Determination of the oxygen saturation of arterial blood using an oximeter.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dexamethasone Regimens for Prophylaxis of Paclitaxel-associated Hypersensitivity Reaction	NCT02349763	Hypersensitivit...	Intravenous Dex... Oral Dexamethas...	18 Years - 70 Years	Rajavithi Hospital
Pilot Trial on Efficacy of Single Dose Perioperative Intravenous Dexamethasone for Pain Relief After Endoscopic Submucosal Dissection	NCT02037399	Early Gastric C...	intravenous dex... intravenous nor...	20 Years - 80 Years	Yonsei University
Dexamethasone Regimens for Prophylaxis of Paclitaxel-associated Hypersensitivity Reaction	NCT02349763	Hypersensitivit...	Intravenous Dex... Oral Dexamethas...	18 Years - 70 Years	Rajavithi Hospital
Dexamethasone and Respiratory Function After Mastectomy	NCT02305173	Respiratory; Di...	Intravenous Dex... intravenous sal...	20 Years - 69 Years	Instituto Mexicano del Seguro Social

Spots Global Cancer Trial Database for intravenous dexamethasone