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CLINICAL TRIALS PROFILE FOR ATROPINE SULFATE

Clinical Trials for Atropine Sulfate

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00458003	Phenylephrine in Spinal Anesthesia in Preeclamptic Patients	Recruiting	Northwestern University	N/A	Hypotension remains a common clinical problem after induction of spinal anesthesia for cesarean delivery. Maternal hypotension has been associated with considerable morbidity (maternal nausea and vomiting and fetal/neonatal acidemia). Traditionally, ephedrine has been the vasopressor of choice because of concerns about phenylephrine's potential adverse effect on uterine blood flow. This practice was based on animal studies which showed that ephedrine maintained cardiac output and uterine blood flow, while direct acting vasoconstrictors, e.g., phenylephrine, decreased uteroplacental perfusion. However, several recent studies have demonstrated that phenylephrine has similar efficacy to ephedrine for preventing and treating hypotension and may be associated with a lower incidence of fetal acidosis. All of these studies have been performed in healthy patients undergoing elective cesarean delivery. Preeclampsia complicates 5-6% of all pregnancies and is a significant contributor to maternal and fetal morbidity and mortality. Many preeclamptic patients require cesarean delivery of the infant. These patients often have uteroplacental insufficiency. Given the potential for significant hypotension after spinal anesthesia and its effect on an already compromised fetus, prevention of (relative) hypotension in preeclamptic patients is important. Spinal anesthesia in preeclamptic patients has been shown to have no adverse neonatal outcomes as compared to epidural anesthesia when hypotension is treated adequately. Due to problems related to management of the difficult airway and coagulopathy, both of which are more common in preeclamptic women, spinal anesthesia may be the preferred regional anesthesia technique. Recent studies have demonstrated that preeclamptic patients may experience less hypotension after spinal anesthesia than their healthy counterparts. To our knowledge, phenylephrine for the treatment of spinal anesthesia-induced hypotension has not been studied in women with preeclampsia. The aim of our study is to compare intravenous infusion regimens of phenylephrine versus ephedrine for the treatment of spinal anesthesia induced hypotension in preeclamptic patients undergoing cesarean delivery. The primary outcome variable is umbilical artery pH.
NCT00947596	A Study of Inhaled Atropine Sulfate in Healthy Adults	Completed	U.S. Army Space and Missile Defense Command	Phase 1	MicroDose Defense Products, LLC is developing an atropine dry powder inhaler (ADPI). This pilot study compares the pharmacokinetics (PK) of inhaled dry powder atropine as delivered by the ADPI to atropine delivery from the AtroPen autoinjector.
NCT00947596	A Study of Inhaled Atropine Sulfate in Healthy Adults	Completed	University of Pittsburgh	Phase 1	MicroDose Defense Products, LLC is developing an atropine dry powder inhaler (ADPI). This pilot study compares the pharmacokinetics (PK) of inhaled dry powder atropine as delivered by the ADPI to atropine delivery from the AtroPen autoinjector.
NCT00947596	A Study of Inhaled Atropine Sulfate in Healthy Adults	Completed	MicroDose Defense Products L.L.C.	Phase 1	MicroDose Defense Products, LLC is developing an atropine dry powder inhaler (ADPI). This pilot study compares the pharmacokinetics (PK) of inhaled dry powder atropine as delivered by the ADPI to atropine delivery from the AtroPen autoinjector.
NCT00998205	Early Diagnosis of Diastolic Dysfunction and Reliability of DSE in Detecting Stress Diastolic Dysfunction	Completed	Veterans Administration, Kansas City	N/A	The heart becoming "stiff" due to increased fibrous tissue or decreased elasticity of the heart tissue is one of the earliest changes caused by heart failure. These changes can be detected by simple non-invasive echocardiogram techniques. However, these techniques usually detect the increased "stiffness" of the heart only after it has progressed to a significant extent. The investigators hypothesize that if they stress the heart using a Dobutamine infusion and measure the filling pressure using echocardiogram, it will provide them with tools to identify these changes earlier.
NCT00998205	Early Diagnosis of Diastolic Dysfunction and Reliability of DSE in Detecting Stress Diastolic Dysfunction	Completed	University of Missouri-Columbia	N/A	The heart becoming "stiff" due to increased fibrous tissue or decreased elasticity of the heart tissue is one of the earliest changes caused by heart failure. These changes can be detected by simple non-invasive echocardiogram techniques. However, these techniques usually detect the increased "stiffness" of the heart only after it has progressed to a significant extent. The investigators hypothesize that if they stress the heart using a Dobutamine infusion and measure the filling pressure using echocardiogram, it will provide them with tools to identify these changes earlier.
Trial ID	Title	Status	Sponsor	Phase	Summary