Clinical Trials Logo

Clinical Trial Summary

This study evaluates whether Ramelteon can prevent delirium, decrease the severity of incident delirium and improve sleep wake cycle in hospitalized elderly surgical patients. Half of the patients will be assigned to Ramelteon, while other half will be assigned to placebo.


Clinical Trial Description

Delirium is a common clinical syndrome characterized by acute cognitive dysfunction with core features of inattention, disorganized thinking, perceptual disturbances and sleep-wake cycle disruption. It is typically multifactorial and can be triggered by acute infection, metabolic derangements, surgery, and certain medications. Older adults have a much higher incidence of delirium. Delirium increases in-hospital mortality, length of stay, rate of institutionalization and may cause or exacerbate cognitive impairment. The present pilot study investigates sleep loss as potentially important contributing factors in delirium and an opportunity for intervention. Sleep disruption is prevalent among hospitalized patients. Sufficient sleep is important for recovery from illness, management of pain, wound healing, and a variety of other biologic functions integral to recovery in addition to its putative role in delirium prevention. Melatonin plays an important role in circadian rhythms and sleep-wake cycle regulation. Melatonin secretion is altered in hospitalized older patients in comparison with community-living older individuals. Melatonin and the melatonin-receptor agonist Ramelteon have been studied and have shown promise in delirium prevention, in addition to promoting sleep. We propose to test the use of Ramelteon to decrease delirium and improve sleep/wake cycles in the elderly surgical patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03165695
Study type Interventional
Source Brigham and Women's Hospital
Contact
Status Withdrawn
Phase Phase 4
Start date December 1, 2019
Completion date December 31, 2019

See also
  Status Clinical Trial Phase
Completed NCT05690672 - Screening for Delirium in Older Inpatients N/A
Completed NCT04656379 - The Incidence and Risk Factors of Postoperative Delirium
Recruiting NCT04187807 - Efficacy of the Administration of Melatonin 5mg in the Prevention of Delirium in Older Adults Hospitalized in the Emergency Department N/A
Active, not recruiting NCT04654962 - Use of Anesthetic Block for the Prevention of in Hospital Delirium in Patients of the Orthogeriatric Clinical Care Center of the HUFSFB and HUSJI From 2019 - 2020
Completed NCT03485183 - The Effect of White and Pink Noise on Hospitalized Older Adults N/A
Recruiting NCT05815017 - YOOMI: Effect of Gamified Physical Therapy Exercise Software on Inpatient Mobility N/A
Recruiting NCT05694091 - Correlation of Perioperative Brain Metabolites With Postoperative Delirium in Elderly Oral Craniomaxillofacial Surgery Patients
Completed NCT06382961 - Postoperative Dexmedetomidine in Prevention of Postoperative Delirium N/A
Recruiting NCT06100029 - The Effect of Lavender Essential Oil for Delirium in Elderly Intensive Care Unit Patients: Study Protocol N/A
Not yet recruiting NCT06111300 - Dexmedetomidine Effect on Delirium of Elderly Patients Phase 4
Recruiting NCT05391334 - Early Fall Risk Detection and Fall Prevention Among Inpatients With Delirium
Completed NCT06168773 - Combination of Haloperidol and Magnesium for Delirium Prevention in Critically Ill Elderly Phase 2/Phase 3
Recruiting NCT05280860 - Effect of Bilateral RSB on Postoperative Delirium in Elderly Patients Undergoing Laparoendoscopic Single-site Surgery N/A
Recruiting NCT05857462 - The Impact of Integrated Preoperative Fascia Iliaca Compartment Block in Elderly Hip Fracture N/A
Recruiting NCT04404959 - Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture N/A
Not yet recruiting NCT05819723 - Erector Spinae Block and Incidence of Postoperative Delirium After Hip Fracture Surgeries N/A
Recruiting NCT04393272 - Digital Intelligent Assistant for Nursing Application
Recruiting NCT05158998 - Impact of Propofol Versus Sevoflurane on Incidence of Postoperative Delirium in Elderly Patients After Spine Surgery Phase 4
Not yet recruiting NCT06326372 - The Effect of Intraoperative Hyperoxemia on Postoperative Delirium in Geriatric Patients
Completed NCT03175276 - Informant Questionaire on Cognitive Decline in the Elderly (IQCODE) and Delirium in Geriatric Patients