Richmond Agitation-Sedation Scale

New Study Finds That Masimo SedLine® Patient State Index (PSi) Has the Potential to Improve Brain Monitoring for Patients Sedated with Dexmedetomidine

Retrieved on: 
Monday, August 7, 2023
Health, Medical Devices, Biometrics, Surgery, Clinical Trials, Research, Science, CD, BIS, Dexmedetomidine, Frontiers, Stanford University, RASS, Psi, Multimedia, Brain, Doctor of Philosophy, Richmond Agitation-Sedation Scale, Anesthesia, MASI, MD, Patient, EEG, Diagnosis, Richmond, Obstructive sleep apnea, Medical imaging, Neuroscience

The researchers found that Masimo Patient State Index (PSi), a SedLine parameter derived from electroencephalographic (EEG) data, was statistically significantly associated with dexmedetomidine dosage, and, along with another EEG metric, “better captured changes in brain state from dexmedetomidine and ha[s] potential to improve the monitoring of dexmedetomidine sedation.”1

Key Points: 
  • The researchers found that Masimo Patient State Index (PSi), a SedLine parameter derived from electroencephalographic (EEG) data, was statistically significantly associated with dexmedetomidine dosage, and, along with another EEG metric, “better captured changes in brain state from dexmedetomidine and ha[s] potential to improve the monitoring of dexmedetomidine sedation.”1
    This press release features multimedia.
  • Better sedation assessment – an improved understanding of its impact and corresponding EEG changes – could help support more widespread adoption of the drug.
  • To evaluate the efficacy of these methods, the researchers compared them both against dexmedetomidine concentration and against each other.
  • This work helps clinicians use SedLine as an objective measure reflecting how the brain is responding to this important sedative, dexmedetomidine.”

Trevena Reports Fourth Quarter 2022 Results and Provides Business Update

Retrieved on: 
Thursday, March 30, 2023
Epilepsy, Vomiting, Male, Cleveland Clinic, Central nervous system, Senior, Delirium, ARTEMIS, Atrium Health Wake Forest Baptist, EMR, Trevena, PACU, Confusion Assessment Method, CNS, Richmond Agitation-Sedation Scale, Sale, Incidence, Data analysis, Length of stay, Patient, Central nervous system disease, Risk, Nausea, Webcast, Transcranial magnetic stimulation, Hospital, Richmond, Abdominal ultrasonography, GI, S1P, Antiemetic, Peripheral nervous system, Nursing, Pharmaceutical industry, Cryptocurrency, Electroencephalography

CHESTERBROOK, Pa., March 30, 2023 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the fourth quarter ended December 31, 2022 and provided an overview of its recent operational highlights.

Key Points: 
  • As reference, in pooled data for the Company’s pivotal Phase 3 studies of OLINVYK, the GI complete response rate was 46.2% (0.35mg) and 39.7% (0.50mg).
  • Analysis of respiratory data from VOLITION is not yet available, and the Company expects to report these data mid-2023.
  • In the fourth quarter of 2022, the commercial team signed contracts with three new specialty distributors that focus primarily on ambulatory surgery centers (ASCs).
  • Cash and cash equivalents were $38.3 million as of December 31, 2022, which the Company believes will be sufficient to fund the Company’s operating expenses and capital expenditure requirements into the fourth quarter of 2023.

Trevena Announces Initial Topline OLINVYK Data from ~200 Patient Real-World Clinical Outcomes Study

Retrieved on: 
Thursday, March 30, 2023
Cognition, Wakefulness, ASA, Cleveland Clinic, Central nervous system, Delirium, ARTEMIS, Atrium Health Wake Forest Baptist, EMR, Trevena, Record, Woman, Colectomy, PACU, CNS, Richmond Agitation-Sedation Scale, Șaeș, Vomiting, PCA, Data analysis, Patient, Risk, Disease, Nausea, Richmond, Cleveland, Wake Forest Baptist Health Wilkes Medical Center, GI, Consciousness, Nursing, Medical imaging, Pharmaceutical industry

CHESTERBROOK, Pa., March 30, 2023 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced initial topline OLINVYK data from two related real-world outcomes studies: VOLITION and ARTEMIS.

Key Points: 
  • Initial GI and cognition data are available, with respiratory outcome data expected mid-2023.
  • The ARTEMIS study was an electronic medical records (EMR) based assessment focused on clinical and health resource utilization outcomes.
  • Initial ARTEMIS data from Wake Forest Baptist Health is currently available, representing 96 OLINVYK-treated patients and 457 matched patients treated with other IV opioids.
  • VOLITION is a real-world, open-label, multi-site, post-approval clinical outcomes study in 203 adult patients undergoing major non-cardiac surgery.

Sedana Medical receives FDA Fast Track Designation in the United States

Retrieved on: 
Wednesday, January 4, 2023
Richmond Agitation-Sedation Scale, Patient, Fast track (FDA), Communication, Respiratory failure, Food, Accelerated approval (FDA), Fast Track, Propofol, Inhalation sedation, Certification, III, FN, ICU, New Drug Application, FDA, Safety, Priority review, News, FTD, White Light Rock & Roll Review, NDA, Isoflurane, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, RASS, Pharmaceutical industry, Medical device, Weapon, Nordic

Fast Track is a process designed to facilitate the development, and expedite the review of therapies that treat serious conditions and fill an unmet medical need.

Key Points: 
  • Fast Track is a process designed to facilitate the development, and expedite the review of therapies that treat serious conditions and fill an unmet medical need.
  • Sedana Medical is aiming for a combination registration of the medical device Sedaconda ACD and the pharmaceutical isoflurane for sedation of mechanically ventilated intensive care patients in the United States.
  • Sedana Medical will engage in discussions with the FDA on how the development program can benefit from the FTD.
  • Sedana Medical was founded in 2005, is listed on Nasdaq First North Growth Market (SEDANA) and headquartered in Stockholm, Sweden.

Sedana Medical receives FDA Fast Track Designation in the United States

Retrieved on: 
Wednesday, January 4, 2023
Richmond Agitation-Sedation Scale, Patient, Fast track (FDA), Communication, Respiratory failure, Food, Accelerated approval (FDA), Fast Track, Propofol, Inhalation sedation, Certification, III, FN, ICU, New Drug Application, FDA, Safety, Priority review, News, FTD, White Light Rock & Roll Review, NDA, Isoflurane, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, RASS, Pharmaceutical industry, Medical device, Weapon, Nordic

Fast Track is a process designed to facilitate the development, and expedite the review of therapies that treat serious conditions and fill an unmet medical need.

Key Points: 
  • Fast Track is a process designed to facilitate the development, and expedite the review of therapies that treat serious conditions and fill an unmet medical need.
  • Sedana Medical is aiming for a combination registration of the medical device Sedaconda ACD and the pharmaceutical isoflurane for sedation of mechanically ventilated intensive care patients in the United States.
  • Sedana Medical will engage in discussions with the FDA on how the development program can benefit from the FTD.
  • Sedana Medical was founded in 2005, is listed on Nasdaq First North Growth Market (SEDANA) and headquartered in Stockholm, Sweden.

BioXcel Therapeutics Announces Initiation of Phase 2 PLACIDITY Trial of BXCL501 for the Treatment of Delirium Related Agitation

Retrieved on: 
Thursday, February 25, 2021
Medical specialties, Psychiatric diagnosis, Clinical medicine, Medicine, Intensive care medicine, Cognitive disorders, Dementia, Delirium, Richmond Agitation-Sedation Scale, Sedation, Agitation, Bipolar disorder

The initiation of PLACIDITY marks an important milestone in our efforts to showcase BXCL501s ability to calm patients struggling with delirium related agitation, our fifth potential indication for this candidate, commented Vimal Mehta, Chief Executive Officer of BioXcel.

Key Points: 
  • The initiation of PLACIDITY marks an important milestone in our efforts to showcase BXCL501s ability to calm patients struggling with delirium related agitation, our fifth potential indication for this candidate, commented Vimal Mehta, Chief Executive Officer of BioXcel.
  • The PLACIDITY trial is a multicenter, randomized, double-blind, placebo-controlled, ascending dose-finding, adaptive Phase 2 study designed to evaluate the safety, efficacy, and pharmacokinetics of BXCL501 in intensive care unit adult patients experiencing delirium related agitation, including COVID-19 patients.
  • The primary endpoint is the reduction in agitation measured by at least a 2-point drop in the Richmond Agitation Sedation Scale (RASS) at two hours post BXCL501 administration.
  • BXCL501 has been studied in two Phase 3 trials (SERENITY I and II) for the acute treatment of schizophrenia related agitation and bipolar disorder related agitation, respectively, and in a Phase 1b/2 trial (TRANQUILITY) for the acute treatment of dementia related agitation.