2025
Protocol and design of the REPOSE study: a double-blinded, randomised, placebo-controlled trial to evaluate the efficacy of suvorexant to improve postoperative sleep and reduce delirium severity in older patients undergoing non-cardiac surgery
Fallon J, Hashemaghaie M, Peterson C, Tran D, Wu S, Valdes J, Pedicini N, Adams M, Soltis M, Mansour W, Wright M, Raghunathan K, Treggiari M, Sasannejad C, Devinney M. Protocol and design of the REPOSE study: a double-blinded, randomised, placebo-controlled trial to evaluate the efficacy of suvorexant to improve postoperative sleep and reduce delirium severity in older patients undergoing non-cardiac surgery. BMJ Open 2025, 15: e091099. PMID: 40081971, PMCID: PMC11907038, DOI: 10.1136/bmjopen-2024-091099.Peer-Reviewed Original ResearchConceptsNon-cardiac surgeryTotal sleep timeEfficacy of suvorexantRandomised controlled trialsTwo-sample t-testPostoperative sleepOlder patientsAssociated with prolonged hospitalizationDelirium severityDecrease delirium severityIncreased total sleep timeStudy drug dosePlacebo-controlled trialPostoperative inpatient stayLong-term cognitive impairmentFood and Drug AdministrationOlder surgical patientsPostoperative sleep disturbancePrimary endpoint dataRisk of deliriumT-testOral suvorexantInstitutional review boardPostoperative delirium severityOrexin-1
2024
Design and implementation of community consultation for research conducted under exception from informed consent regulations for the PreVent and the PreVent 2 trials: Changes over time and during the COVID-19 pandemic
Gugel T, Adams K, Baranoski M, Yanez N, Kampp M, Johnson T, Aydin A, Fajardo E, Sharp E, Potnis A, Johnson C, Treggiari M. Design and implementation of community consultation for research conducted under exception from informed consent regulations for the PreVent and the PreVent 2 trials: Changes over time and during the COVID-19 pandemic. Clinical Trials 2024, 21: 671-680. PMID: 38676438, PMCID: PMC11512686, DOI: 10.1177/17407745241243045.Peer-Reviewed Original ResearchPublic disclosure activitiesCommunity consultationInstitutional review boardConsent regulationsIn-personEmergency researchRegulatory measuresCOVID-19 pandemicPublic disclosureSponsor-investigatorsPublic supportPrevention experimentsCommunity leadersIn-person eventsYear of implementationFood and Drug AdministrationHigher education levelCommunity concernsReview boardSelection biasProportion of respondentsMethod of contactClinical researchLocal communitiesCOVID-19
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