What's New | Decker

Because of the complex nature of clinical trial design, significant resources and infrastructure are invested in drug development. Many drugs fail to progress beyond the phase I/II stage, and many phase III trials take years to accrue and publish results, leading to a delay in Food and Drug Administration (FDA) approval for diseases that desperately need better therapeutic options. The relatively recent FDA Safety and Innovation Act has allowed for the creation of priority and expedited review for drugs and biologics in serious conditions and where there is an unmet medical need. The designation of fast-track or breakthrough therapy may be granted when there is preclinical or clinical evidence to suggest that the intervention may result in a substantial improvement over currently available therapies.
Prior to embarking on a clinical trial, data entry, editing (“cleaning”), and analysis should be anticipated. Planning for data management begins with developing rules for coding the variables for computer entry. The appropriate hardware and software programs should be selected and standardized across study sites.
A type I error (false positive) occurs if an investigator rejects a null hypothesis that is true in the population. A type II error (false negative) occurs if the investigator fails to reject a null hypothesis that is false in the population. Neither of these errors can be avoided entirely.

Labor pain is a complex entity, and no single therapy is right for all patients.
Inhalation of nitrous oxide and intramuscular/intravenous opioids provide mild to moderate pain relief with side effects of nausea and sedation.
The development of low-dose epidural medications has decreased the side effects of this modality while still providing excellent pain relief.
Short-acting, lipophilic opioids administered by patient-controlled analgesia can provide good pain relief for many patients.
Providing analgesic medications, whether inhalational, intramuscular/intravenous, or neuraxial, does not affect the duration of labor or the mode of delivery in randomized studies.

The initial assessment of the patient with suspected AHF should focus on immediate life-threatening conditions. Careful attention should be paid to vital signs. Hypoxia should be treated with supplemental oxygenation and may be a marker for impending respiratory failure. The history should help ascertain possible causes of exacerbation of HF, as well as risk factors or symptoms suggestive of HF mimics.
Nesiritide is a recombinant BNP that, similar to NTG, is a venous, arterial, and coronary dilator. Several early trials demonstrated improved hemodynamics with nesiritide, with a suggestion of some clinical benefit. However, data from these trials failed to demonstrate a mortality benefit and questions arose about the possibility of increased renal insufficiency and worse mortality with its use.
Sodium nitroprusside can be similarly used to decrease both preload and afterload. Observational data have suggested a mortality benefit in AHF patients treated with nitroprusside, but randomized trial data appear to be limited to patients with acute myocardial infarction and have not been able to demonstrate a mortality decrease.

Two new tests are now available: thromboelastography and the thrombin generation test.
Both assays provide much more information than the conventional clotting times
New generations of devices allow both tests to be performed in an automated manner, leading to greater reproducibility and less variation among laboratories.

The initial assessment of the patient with suspected AHF should focus on immediate life-threatening conditions. Careful attention should be paid to vital signs. Hypoxia should be treated with supplemental oxygenation and may be a marker for impending respiratory failure. The history should help ascertain possible causes of exacerbation of HF, as well as risk factors or symptoms suggestive of HF mimics.
Nesiritide is a recombinant BNP that, similar to NTG, is a venous, arterial, and coronary dilator. Several early trials demonstrated improved hemodynamics with nesiritide, with a suggestion of some clinical benefit. However, data from these trials failed to demonstrate a mortality benefit and questions arose about the possibility of increased renal insufficiency and worse mortality with its use.
Sodium nitroprusside can be similarly used to decrease both preload and afterload. Observational data have suggested a mortality benefit in AHF patients treated with nitroprusside, but randomized trial data appear to be limited to patients with acute myocardial infarction and have not been able to demonstrate a mortality decrease.

Two new tests are now available: thromboelastography and the thrombin generation test.
Both assays provide much more information than the conventional clotting times
New generations of devices allow both tests to be performed in an automated manner, leading to greater reproducibility and less variation among laboratories.

The dual-tracer technique of lymphatic mapping has the highest accuracy rates, and most melanoma surgeons prefer this method. Methylene blue is generally avoided due to the high rate of skin necrosis at the site of injection. It should not be considered in melanoma patients in whom the injection site is not going to be excised and should not be considered in breast cancer patients unless a total mastectomy is being performed. Isosulfan blue is most commonly used but is associated with a rare incidence of anaphylaxis. Thus, isosulfan blue should never be used in a setting without direct anesthesia care provided.

The dual-tracer technique of lymphatic mapping has the highest accuracy rates, and most melanoma surgeons prefer this method. Methylene blue is generally avoided due to the high rate of skin necrosis at the site of injection. It should not be considered in melanoma patients in whom the injection site is not going to be excised and should not be considered in breast cancer patients unless a total mastectomy is being performed. Isosulfan blue is most commonly used but is associated with a rare incidence of anaphylaxis. Thus, isosulfan blue should never be used in a setting without direct anesthesia care provided.

Ambulatory Anesthesia/General Anesthesia/Bariatric Surgery