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The purpose of this study is to evaluate the safety and efficacy of LUSEDRA (fospropofol disodium) and to determine whether a dose lower than currently approved can provide effective moderate sedation required to complete diagnostic or therapeutic procedures.
This will be a double-blind, randomized, parallel-group, multicenter, dose-ranging study, in age >/= 65 years, and/or weight < 60 kg, and/or American Society of Anesthesiologists (ASA) Physical Classification Status 3 or 4 subjects using either the approved dose modification or 1 lower dose, to achieve a moderate level of sedation required to complete the scheduled diagnostic or therapeutic procedure. Three subgroups of subjects will be included. For Subgroup 1 and Subgroup 2, approximately equal numbers of subjects will be enrolled into 2 strata: weight >/= 55 kg and weight < 55 kg. For Subgroup 1 and Subgroup 2, subjects will be randomly assigned to 1 of 2 dose groups in a 1:1 ratio within each stratum. For Subgroup 3, subjects will be randomly assigned to 1 of 2 dose groups in a 1:1 ratio.
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
fospropofol disodium (Dose of Initial IV (Titration) Bolus 6.5mg/kg), fospropofol disodium (Dose of Initial IV (Titration) Bolus 4.875 mg/kg), fospropofol disodium (Dose of Initial IV (Titration) Bolus 3.9mg/kg), fospropofol disodium (Dose of Initial IV (
Hope Research Institute
Published on BioPortfolio: 2014-08-27T03:13:33-0400
Very often patients receive medication before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural ...
Very often, patients receive sedative medication before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called ...
The purpose of this study is to determine the safety, tolerability, and efficacy of AQUAVAN® Injection when used for mild-to-moderate sedation in patients undergoing minor surgical proced...
The objective of this study was to assess the bioequivalence of a potential generic 750 mg balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg balsalazide ...
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is s...
To compare the occurrence of transient severe motion (TSM) between gadoxetate disodium- and gadopentetate dimeglumine-enhanced MRI and between gadoxetate disodium-enhanced MRI scans obtained with and ...
Background Gadoxetate disodium is an intracellular contrast agent for magnetic resonance imaging (MRI) of the liver. Recent publications revealed that injection of gadoxetate disodium can lead to im...
To determine whether oxygen inhalation reducing artifacts in patients with previous transient severe motion (TSM) on gadoxetate-disodium-enhanced MRI.
To assess the interrater agreement and reliability of experienced abdominal radiologists in the characterization and grading of arterial phase gadoxetate disodium-related respiratory motion artifac...
Value of hepatocellular phase imaging after intravenous gadoxetate disodium for assessing hepatic metastases from gastroenteropancreatic neuroendocrine tumors: comparison with other MRI pulse sequences and with extracellular agent.
To compare hepatocellular phase imaging after intravenous gadoxetate disodium with other MRI pulse sequences and with extracellular agent for assessing hepatic metastases from gastroenteropancreatic n...
Selenious acid, disodium salt. It is used therapeutically to supply the trace element selenium.
A colorimetric reagent for iron, manganese, titanium, molybdenum, and complexes of zirconium. (From Merck Index, 11th ed)
A variable mixture of the mono- and disodium salts of gold thiomalic acid used mainly for its anti-inflammatory action in the treatment of rheumatoid arthritis. It is most effective in active progressive rheumatoid arthritis and of little or no value in the presence of extensive deformities or in the treatment of other forms of arthritis.
The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.
Relief of PAIN, without loss of CONSCIOUSNESS, through ANALGESIC AGENTS administered by the patients. It has been used successfully to control POSTOPERATIVE PAIN, during OBSTETRIC LABOR, after BURNS, and in TERMINAL CARE. The choice of agent, dose, and lockout interval greatly influence effectiveness. The potential for overdose can be minimized by combining small bolus doses with a mandatory interval between successive doses (lockout interval).