How to Quickly Spot Signs of Stroke...

How to Quickly Spot Signs of Stroke: Experts.

FDA: MONDAY May 13, 2013 -- Sudden numbness or weakness in the face, arms or legs on one side of the body, confusion and trouble speaking are among the signs that someone is having a stroke.

The sooner a stroke is recognized and treated, the greater the chance of recovery, experts say.

"When someone has a stroke, they may show either slight or extremely noticeable physical changes"; "The most effective way to prevent the permanent damage associated with stroke is to recognize the signs of an attack and to seek medical attention immediately."

Dizziness and trouble walking, loss of vision in one or both eyes and a severe headache that comes on suddenly for no apparent reason are other signs that someone is having a stroke. Early treatment, however, can prevent or possibly reverse the damage caused by strokes. The experts advised remembering the acronym "FAST" to help people recognize a stroke sooner and reduce any long-term damage.

·         F for Face: Does someone's face look uneven?

·         A for Arm: Do you notice one arm hanging down?

·         S for Speech: Check for slurred speech or other signs of trouble speaking.

·         T for Time: Call 911 and seek immediate medical attention.

One of the most common treatments for stroke is tissue plasminogen activator, the "clot-busting" treatment also known as TPA. The drug is injected into an artery or vein to dissolve a clot and restore blood flow to the brain.

Revascularization is another treatment for stroke in which micro-catheters are placed inside the artery to remove blockages. In all cases, immediate medical attention can help reduce the damage caused by a stroke, according to the news release.

Learning how to prevent strokes with certain lifestyle changes can also save lives, the experts pointed out. "Stroke statistics are sobering: It's the fourth leading cause of death in the United States and the leading cause of adult disabilities"; "On average, someone dies of stroke every four minutes." "The good news is that approximately 80 %  of strokes can be prevented."

Lifestyle changes that can significantly reduce the risk of having a stroke include the following:

·         Cut back on salt. Reducing salt intake can lower blood pressure, reducing the risk for stroke. Instead of salt, season food with a variety of spices.

·         Eat a healthy diet. Reduce LDL (or "bad") cholesterol levels to improve heart health and reduce the risk for stroke. Cholesterol levels should be 200 milligrams per deciliter (mg/dL) or below.

·         Quit smoking. Smokers have twice the risk of having a stroke. Smoking damages blood vessels, increases blood pressure and accelerates the clogging of arteries.

·         Exercise. People who are overweight or obese are at greater risk for high cholesterol, high blood pressure, diabetes and stroke. Losing weight can lower the risk for stroke and ease the strain on the circulatory system.

Even with these lifestyle changes, the experts pointed out that people aged 55 years or older are still at greater risk for stroke. Also at greater risk are black people, Hispanics and those with a family history of stroke or "mini-stroke" (also called a transient ischemic attack).

Although strokes are more common in men, women who have strokes are more likely to die from them, according to the news release.

More information

Visit the U.S. National Library of Medicine to learn more about stroke treatment and prevention.

Arbor Pharmaceuticals Announces FDA Approval of Nymalize...

FDA Approves Nymalize

Arbor Pharmaceuticals Announces FDA Approval of Nymalize

FDA: May 13, 2013 - Atlanta, GA - Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Nymalize (nimodipine) oral solution. Nymalize was previously granted Orphan designation which provides seven years of market exclusivity.

Nymalize is the first and only nimodipine oral solution indicated for the improvement of neurological outcome in adult patients with subarachnoid hemorrhage (SAH).

Prior to the approval of Nymalize, nimodipine was only available in gel capsule form. Since the product is commonly administered to patients through a nasogastric tube healthcare providers would extract the product from the gel capsule with a syringe. This has resulted in accidental administrations of nimodipine intravenously instead of via the intended enteral (oral) syringe.

In 2010, the FDA issued a "drug safety communication" to healthcare professionals titled “Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harm.” In this communication they reported twenty-five intravenous nimodipine prescribing or administration errors and that four of the patients who mistakenly received nimodipine intravenously died and five had near-death events. The Institute for Safe Medication Practice reported an additional death due to improper nimodipine administration in February 2013.

Ed Schutter, President & CEO of Arbor stated, “I am pleased that Arbor’s first NDA approval has the potential to save lives by reducing the opportunity for hospital administration errors. To further ensure that we minimize the potential for administration error, each Nymalize unit dose cup will be packaged with an oral syringe. Nymalize adds to our growing portfolio of approved prescription products that can improve the lives of our patients.”

Dr. Laurence Downey, VP of Medical & Scientific Affairs added, “Approval of our first NDA is an important milestone in the evolution of Arbor Pharmaceuticals. This is the first of what we hope will be multiple NDA approvals over the next several years. I would like to thank and congratulate our team that worked on the Nymalize NDA.”

Arbor Pharmaceuticals will launch Nymalize in the next few months.

About Nymalize

Nymalize (nimodipine) oral solution is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with SAH from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V).

Important Safety Information About Nymalize

Blood pressure should be carefully monitored during treatment with Nymalize (nimodipine) oral solution. Nimodipine may increase the blood pressure lowering effect of concomitantly administered anti-hypertensives such as diuretics, beta-blockers, ACE inhibitors, angiotensin receptor blockers, other calcium channel blockers, α-adrenergic blockers, PDE5 inhibitors, and α-methyldopa.

Patients with cirrhosis are at a higher risk of adverse reactions and should be monitored closely and administered a lower dose.

Concomitant use of strong inhibitors of CYP3A4 with nimodipine should generally be avoided due to risk of significant hypotension. These include some macrolide antibiotics (e.g. clarithromycin, telithromycin), some HIV protease inhibitors (e.g., indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (e.g., boceprevir, telaprevir), some azole antimycotics (e.g., ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan, delaviridine, and nefazadone.

Concomitant use of strong CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampin, St. John’s wort) and nimodipine should generally be avoided, as nimodipine plasma concentration and efficacy may be significantly reduced.

Nimodipine plasma concentration can also be increased in the presence of moderate and weak inhibitors of CYP3A4. If nimodipine is concomitantly administered with these drugs, blood pressure should be monitored, and a reduction of the nimodipine dose may be necessary.

Grapefruit juice inhibits CYP3A4. Ingestion of grapefruit/grapefruit juice is not recommended while taking nimodipine.

Moderate and weak inducers of CYP3A4 may also reduce the efficacy of nimodipine. Patients on these should be closely monitored for lack of effectiveness, and a nimodipine dosage increase may be required.

Common Adverse Reactions

Most common adverse reactions (incidence ≥ 1% and ≥1% placebo) were hypotension, headache, nausea, and bradycardia.

About Arbor Pharmaceuticals

Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company currently focused on the hospital, cardiovascular and pediatric markets. The company has 175 sales professionals in the field which promote its products to hospitals and physicians. Arbor intends to become a leading specialty pharmaceutical company by actively licensing, developing and commercializing late-stage products for specialty focused conditions. Arbor currently markets fifteen NDA and ANDA approved products with twenty-eight more in development.

Source: Arbor Pharmaceuticals

Accidental Awareness During Anesthesia Is Rare.

Accidental Awareness During Anesthesia Is Rare.

A Very few surgical patients experience accidental awareness while under general anesthesia.

The survey of the senior anesthetists at National Health Service hospitals in the United Kingdom about cases of accidental awareness during general anesthesia encountered in 2011.

Previous research has suggested a high rate of accidental awareness, occurring in about one in 500 patients.

But this study found that the rate was one in 15,000.

The researchers also found that only about 2 % of anesthetists routinely use brain-monitoring equipment to keep tabs on patients during surgery.

The findings, published in the journals Anesthesia and The British Journal of Anaesthesia, appeared online March 12.

"Anesthesia is a medical specialty very much focused on safety and patient experience," study lead author Jaideep Pandit, a consultant anesthetist in Oxford, said in an Anesthesia news release. "We identified accidental awareness during anesthesia as something which concerns patients and the profession. The profession is therefore undertaking this major study so that we can better understand the problem and work to reduce the likelihood of it happening to patients."

"We are particularly interested in patient experiences of awareness," Pandit added. "Although we know that some patients do suffer distress after these episodes, our survey has found that the vast majority of episodes are brief and do not cause pain or distress."

The researchers plan to investigate why their findings are so different from the results of previous studies.

"Risks to patients undergoing general anesthesia are very small and have decreased considerably in the last decades," study co-author Tim Cook, a consultant anesthetist in Bath, said in the news release. "Of the 3 million general anesthetics administered in [National Health Services hospitals] each year, only a very small number of patients experience awareness during anesthesia, with the majority of these occurring before surgery starts or after it finishes."

"While our findings are generally reassuring for patients and doctors alike, we recognize that there is still more work to be done," Cook said. "We are spending the next year studying as many of the cases as possible to learn more from patients' experiences."

THE ANAESTHETIC MANAGEMENT OF THE OBESE CHILDREN Alisher Agzamov, A.M. Al Qattan, Asmahan Al Mulla, A. Y. Dubikaitis Department of Anaesthesiology & ICU, Al Sabah Hospital, Kuwait City, Kuwait More than 42 million children under 5 years of age are overweight across the world. In Asia, in Middle East and in the Gulf region, the number of overweight children and adolescents has doubled in the last two to three decades, and similar doubling rates are being observed worldwide, including in developing countries and regions where an increase in Westernization of behavioral and dietary lifestyles is evident. The definition of childhood obesity has not been standardized in the past, making studies difficult to compare. In spite of this, the increase in the incidence of childhood obesity is evident and has now reached epidemic proportions. Obese children experience few of the medical complications seen in obese adults. 1. Respiratory System is most affected, the degree of which is determined by the level of obesity. 2. A considerable amount of information on the anaesthetic management of the obese adult, but a very little has been written concerning the obese child. 3. There is less pathology in the obese child when compared with the adult but some evidence shows a higher likelihood of a critical incident occurring when anaesthetizing such children. 4. We need to be as worried about anaesthetizing the obese child as we are for the obese adult. This concern should increase with increasing body mass index. Anaesthesia consideration must be given to family behavior patterns, diet after weaning, and the use of new methods of information dissemination to help reduce the impact of childhood obesity worldwide.

THE ANAESTHETIC MANAGEMENT OF THE OBESE CHILDREN

Alisher Agzamov, A.M. Al Qattan, Asmahan Al Mulla, A. Y. Dubikaitis

Department of Anaesthesiology & ICU, Al Sabah Hospital, Kuwait City, Kuwait

More than 42 million children under 5 years of age are overweight across the world.

In Asia, in Middle East and in the Gulf region, the number of overweight children and adolescents has doubled in the last two to three decades, and similar doubling rates are being observed worldwide, including in developing countries and regions where an increase in Westernization of behavioral and dietary lifestyles is evident.

The definition of childhood obesity has not been standardized in the past, making studies difficult to compare. In spite of this, the increase in the incidence of childhood obesity is evident and has now reached epidemic proportions.

Obese children experience few of the medical complications seen in obese adults.

1. Respiratory System is most affected, the degree of which is determined by the level of obesity.

2. A considerable amount of information on the anaesthetic management of the obese adult, but a very little has been written concerning the obese child.

3. There is less pathology in the obese child when compared with the adult but some evidence shows a higher likelihood of a critical incident occurring when anaesthetizing such children.

4. We need to be as worried about anaesthetizing the obese child as we are for the obese adult.

This concern should increase with increasing body mass index. Anaesthesia consideration must be given to family behavior patterns, diet after weaning, and the use of new methods of information dissemination to help reduce the impact of childhood obesity worldwide.

The tougher guidelines on research conduct. Dr. Alisher Agzamov MD PhD

The tougher guidelines on research conduct. Dr. Alisher Agzamov MD phD

Geoff Watts. Research Councils UK issues tougher guidelines on research conduct. BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f1565 (Published 8 March 2013)

Cite this as: BMJ 2013;346:f1565

Research Councils UK has issued more explicit guidelines on the conduct that it expects from holders of its members’ research grants.¹ 

Unlike the document it replaces, published in 2009, it also outlines the likely penalties facing individuals and institutions that knowingly break the rules.

“We want to be seen to be tougher, but there’s a balance to be struck,” said Dr Tony Peatfield, director of corporate affairs at the Medical Research Council. “The more you threaten sticks rather than carrots, the greater the temptation for institutions to bury stuff. I think we’ve got the right balance.”

In the case of proven research misconduct the report lists the sanctions that might be applied. For the individuals concerned the research councils would reserve the right to withdraw funding and disallow future applications for grants for any fixed period of time, or even indefinitely. A researcher’s institution might also be required to return all the money awarded to the individual.

Research Councils UK is the strategic partnership of all seven of the country’s research councils. The new guidelines are now in line with a set of recommendations already laid out in a 2012 concordat on research conduct organised by Universities UK and approved by most of the country’s main funding bodies.

The new guidance sets standards of good research practice and also defines unacceptable research conduct. It explains how alleged misconduct should be reported and investigated and clarifies the responsibilities of the research councils, as opposed to research institutions, in fostering high standards.

The report emphasises the importance, where relevant, of clear procedures for obtaining ethical approval for intended work; seeking the informed consent of subjects; and ensuring that all staff are aware of these procedures.

“Peer reviewers,” it says, “must declare any conflicts of interest, including professional, personal or commercial conflicts, and must not take advantage of any information received as a result of their peer reviewing role.”

Commenting on what it considers to be unacceptable research conduct, the report says, “The spectrum of inappropriate behaviour is wide, ranging from minor misdemeanours which may happen occasionally and inadvertently, to significant acts of misappropriation or fabrication.”

Unacceptable conduct includes the creation of false data, the inappropriate manipulation of data and images, plagiarism, and misrepresentation. The last of these covers the suppression of relevant findings and/or data, the undisclosed duplication of published reports, the failure to declare material interests, false claims about qualifications and/or experience, and inappropriate claims to authorship.

The report suggests that any preliminary investigation of suspected misconduct should be carried out informally, and outlines how this might be done. If the suspicion is substantiated, it describes how a more formal procedure should be conducted.

Notes: Cite this as: BMJ 2013;346:f1565

References

1.    Research Councils UK. RCUK policy and guidelines on governance of good research conduct. www.rcuk.ac.uk/documents/reviews/grc/RCUKPolicyandGuidelinesonGovernanceofGoodResearchPracticeFebruary2013.pdf

General anesthesia.

General anesthesia.

Alisher Agzamov MD PhD.

Introduction

General anesthesia is a treatment that puts you into a deep sleep so you do not feel pain during surgery. When you receive these medications, you will not be aware of what is happening around you.

Description

You will receive general anesthesia in a hospital or outpatient office. Most times, a doctor called an anesthesiologist will put you to sleep. Sometimes, a certified registered nurse anesthetist will take care of you.

The doctor will give you medication into your vein. You may be asked to breathe in (inhale) a special gas through a mask. Once you are asleep, the doctor may insert a tube into your windpipe (trachea) to help you breathe and protect your lungs.

You will be watched very closely while you are asleep. Your blood pressure, pulse, and breathing will be monitored. The doctor or nurse taking care of you can change how deeply asleep you are during the surgery.

You will not move, feel any pain, or have any memories of the procedure because of this medicine.

Why the Procedure Is Performed

General anesthesia is a safe way to stay asleep and pain-free during procedures that would:

·         Be too painful

·         Take a long time

·         Affect your ability to breathe

·         Make you uncomfortable

·         Cause too much anxiety

You may also be able to have conscious sedation for your procedure, but sometimes it isn’t enough to make you comfortable. Children may need general anesthesia for a medical or dental procedure to handle any pain or anxiety they may feel.

Risks

General anesthesia is usually safe for healthy people. The following people may have a higher risk of problems with general anesthesia:

·         People who abuse alcohol or medications

·         People with allergies or a family history of being allergic to medicine

·         People with heart, lung, or kidney problems

·         Smokers

Ask your doctor about these complications:

·         Death (rare)

·         Harm to your vocal cords

·         Heart attack

·         Lung infection

·         Mental confusion (temporary)

·         Stroke

·         Trauma to the teeth or tongue

·         Waking during anesthesia (rare)

Before the Procedure

Always tell your doctor or nurse:

·         If you could be pregnant

·         What drugs you are taking, even drugs or herbs you bought without a prescription

During the days before the surgery:

·         An anesthesiologist will take a complete medical history to determine the type and amount of anesthesia you need. This includes asking you about any allergies, health conditions, medications, and history of anesthesia.

·         Several days before surgery, you may be asked to stop taking aspirin, ibuprofen, warfarin (Coumadin), and any other drugs that make it hard for your blood to clot.

·         Ask your doctor which drugs you should still take on the day of your surgery.

·         Always try to stop smoking. Your doctor can help.

On the day of your surgery:

·         You will usually be asked not to drink or eat anything after midnight the night before the surgery. This is to prevent you from vomiting while you are under anesthesia. Vomiting during anesthesia can be dangerous.

·         Take the drugs your doctor told you to take with a small sip of water.

·         Your doctor or nurse will tell you when to arrive.

After the Procedure

You will wake up tired and groggy in the recovery or operating room. You may also feel sick to your stomach, and have a dry mouth, sore throat, or feel cold or restless until the anesthesia wears off. Your nurse will monitor these side effects. They will wear off, but it may take a few hours. Sometimes nausea and vomiting can be treated with other medicines.

Follow your doctor's recommendations while you recover and care for your surgical wound.

Outlook (Prognosis)

General anesthesia is generally safe because of modern equipment, medications, and safety standards.

Most people recover completely and do not have any complications.

A target-controlled infusion (TCI) Propofol in major trauma patients.

A target-controlled infusion (TCI) Propofol in major trauma patients.

Alisher Agzamov, A. M. Al Qattan, M. Hashti, M. Bahzad.

Department of Anesthesiology & ICU, Al Aabah & Zain Hospitals, MOH, Kuwait City, Kuwait.

BACKGROUND:

Many pathophysiologic alterations in major trauma patients can cause changes in the distribution of, and perhaps response to, drugs commonly used in anesthesia practice. This study was conducted to assess changes in bispectral index (BIS) caused by increasing the target Propofol effect-site concentration during a target-controlled infusion (TCI) in major trauma patients.

METHODS:

120 patients, ASA physical status II, III - IV, aged from 19 to 65 years old, weighing 50-170 kg, with poly multiple major trauma, scheduled for emergency surgery less than a 2 – 10 hours after injury were recruited. A further 120 ASA physical status class II, III - IV, emergency non- trauma surgical patients, age, sex- and weight-matched adult patients scheduled for emergency surgery under general anesthesia were recruited as controls. During anesthesia induction, target propofol effect-site concentrations were increased by increments of 0.5 mcg/ml  up to 5.0 mcg/ml. The BIS responses to each target concentration using TCI were compared in both groups.

RESULTS:

In the trauma group, significantly greater BIS values relating to increasing propofol TCI were noted at deeper anesthesia when compared with controls; at > or =3.0 – 5.0 mcg/ml; mean BIS remained at a plateau of about 40. Patients with traumas had higher cardiac indices, and lower hemoglobin and albumin concentrations than the controls. They consumed more cisatracurium to maintain the same degree of neuromuscular blockade than the controls.

CONCLUSIONS:

In major trauma patients, the final biphasic BIS responses appeared to be determined by numerous other variables such as BIS algorithm, TCI performance, and altered Propofol pharmacokinetics and pharmacodynamics.

According to our results the importance of an individually tailored approach, including careful anesthetic titration, based upon the patient's clinical condition and responses can not be overemphasized.