Computer-Assisted and Patient-Controlled Sedation Platforms.

As the number and complexity of endoscopic procedures increase, the role of sedation has been integral in patient and physician satisfaction. This article discusses the advances of computer-assisted and patient-controlled platforms. These computer-assisted and patient-controlled platforms use different anesthetics and analgesics, all with the intent of achieving improved consistency in the level of sedation, appropriate to the needs of patients, while also improving patient safety.

A Phase IIa, randomized, double-blind study of remimazolam (CNS 7056) versus midazolam for sedation in upper gastrointestinal endoscopy.

Background: This exploratory study was the first study of remimazolam in patients to assess the safety and efficacy of different single doses for procedural sedation.

Methods: Patients scheduled to undergo a diagnostic upper gastrointestinal endoscopy were randomized to receive 1 of 3 doses of remimazolam or midazolam (25 per group) in a double-blind manner. After a single dose of study drug to achieve sedation, patients underwent gastroscopy.

The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process.

Food and Drug Administration (FDA) advisory panels and committees play a critical role in advising the FDA on the safety and efficacy of medical devices and drugs marketed in the US. Advisory panel recommendations are used by the FDA to make decisions regarding medical products. Currently, the FDA utilizes over 50 advisory panels that serve the three major FDA centers, including the Centers for Biologics, Drugs and Device Products.

Computer-assisted personalized sedation for upper endoscopy and colonoscopy: a comparative, multicenter randomized study.

Background: The SEDASYS System is an investigational computer-assisted personalized sedation system integrating propofol delivery with patient monitoring to enable endoscopist/nurse teams to safely administer propofol.

Objective: To compare the safety and effectiveness of the SEDASYS System to the current standard of care for sedation during routine endoscopic procedures.

Design: Nonblinded multicenter randomized comparative study.

Future directions in endoscopic sedation.

The role of sedation in endoscopic procedures has increased and so has the demand for advances in its administration. The pursuit of new agents or administration techniques and their study specific to endoscopic nonsurgical procedures is necessary to improve patient comfort and safety.The science of moderate and deep sedation specific to endoscopy is fledgling but approaching new horizons.

An assessment of computer-assisted personalized sedation: a sedation delivery system to administer propofol for gastrointestinal endoscopy.

Background: Demand for colonoscopy and EGD procedures is increasing. Impediments to performing these examinations persist. Patients perceive these procedures as unpleasant and painful.

Open-label, dose-ranging pilot study of 4 weeks of low-dose therapy with sodium phosphate tablets in chronically constipated adults.

Background: The tablet formulation of sodium phosphate (NaP) is a prescription osmotic purgative that has been marketed since 2001. The use of NaP tablets in patients with constipation has not been studied previously.

Objective: This study assessed the tolerability and efficacy of 28 days of therapy with NaP tablets (1.

Low volume bowel preparation for colonoscopy: randomized, endoscopist-blinded trial of liquid sodium phosphate versus tablet sodium phosphate.

Objective: The aim of this study was to compare the colon-cleansing effectiveness, ease of consumption, and side effect profiles of two commercially available preparations of sodium phosphate: liquid Fleet Phospho-soda and Visicol tablets.

Methods: Outpatients undergoing elective colonoscopy were sequentially randomized to one of two preparation groups: liquid: 45 ml at 7:00 PM, 45 ml 3 h before colonoscopy; or tablet: 20 tablets at 7:00 PM, 20 tablets 3-5 h before colonoscopy. Subjects rated preparation tolerability on a 5-point Likert scale.