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result(s) for
"Al-Huraizi, Aisha"
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Effect of melatonin versus placebo for the prevention of delirium among medically hospitalised older patients: a double-blinded randomised controlled trial (project RESTORE)
by
Al Farsi, Rajaa Saleh
,
Al Huraizi, Aisha Ramadhan
,
Al Alawi, Abdullah M
in
Aged
,
Aged, 80 and over
,
Aging
2026
ObjectivesTo evaluate the efficacy of melatonin, a neurohormone regulating the sleep–wake cycle, in preventing delirium within 5 days of hospitalisation among older adult patients (≥65 years) admitted to general medical wards.DesignSingle-centre, double-blinded, randomised, placebo-controlled trial.SettingGeneral medical wards of a tertiary hospital in Oman.ParticipantsPatients aged ≥65 years admitted within 24 hours to general medical wards were screened. Key exclusion criteria included prevalent delirium, use of vasopressors, non-invasive ventilation, intensive or high-dependency unit admission and aphasia.InterventionsParticipants were randomly assigned to receive either 5 mg or 8 mg of melatonin or a placebo nightly for up to 5 days during hospitalisation or until discharge, whichever occurred first.Primary and secondary outcome measuresThe primary outcome was the incidence of delirium within 5 days, assessed using the 3-Minute Diagnostic Confusion Assessment Method. Secondary outcomes included delirium treatment, average sleep duration or sleep maintained, 28-day mortality and 28-day readmission. Analyses followed the intention-to-treat (ITT) principle, with per-protocol (PP) analyses conducted for robustness.ResultsThe study was terminated early due to futility. At termination, a total of 115 participants were recruited, 109 of whom were included in the ITT analyses: 55 in the melatonin group (5 mg or 8 mg) and 54 in the placebo group. The overall incidence of delirium by day 5 was 2.75%, 3.64% in the melatonin group and 1.85% in the placebo group (p=1.000). No statistically significant differences were found in the average sleep duration (p=0.136), 28-day mortality (3.64% vs 1.85%, p=1.000) or 28-day readmission (21.82% vs 20.37%, p=0.853). PP analyses and subgroup sensitivity yielded similar findings.ConclusionsIn this trial, melatonin did not significantly reduce the incidence of delirium. The lower-than-expected numbers of outcome events and resultant early termination for futility limited the study’s power. As a result, the study findings should be interpreted with caution, and further research is necessary before definitive recommendations can be made.Trial registration numberNCT06509191.
Journal Article
Delirium in Medically Hospitalized Patients: Prevalence, Recognition and Risk Factors: A Prospective Cohort Study
by
Al Farsi, Rajaa Saleh
,
Al Huraizi, Aisha Ramadhan
,
Al-Saadi, Taif
in
Activities of daily living
,
Artificial respiration
,
Care and treatment
2023
Background: Delirium is a common neuropsychiatric syndrome in hospitalized elderly patients and is associated with poor clinical outcomes. We aimed to determine the prevalence, recognition, risk factors, and course of delirium among hospitalized elderly (65 years of age or older) patients at Sultan Qaboos University Hospital (SQUH). Methods: A prospective cohort study included 327 elderly patients (65 years of age or older) admitted to the medical wards at SQUH. Patients were screened for delirium using the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM). Additionally, medical records were reviewed to identify possible associated factors. Results: The prevalence of delirium was 55.4% (95% CI 49.9–60.7), and 35.4% of patients with delirium were not recognized by the treating team. Hypoactive delirium is the most common type of delirium. The logistic regression analyzes demonstrated that pre-existing cognitive impairment (OR = 4.0); poor functional status (OR = 1.9); the use of medications that are known to precipitate delirium (OR = 2.3); polypharmacy (OR = 5.7); urinary catheterization (OR = 2.2); dehydration (OR = 3.1); and electrolytes derangements (OR = 2.0) were independent risk factors for delirium. Furthermore, 56.9% of patients with delirium continued to have delirium upon discharge from the hospital. Conclusions: Delirium is common among elderly patients hospitalized in general medical wards. Implementing effective preventive strategies for delirium during the hospital stay, including early recognition using standard sensitive and specific screening tools (i.e., 3D-CAM) and developing geriatric wards, is crucial.
Journal Article
Delirium and Its Association with Short- and Long-Term Health Outcomes in Medically Admitted Patients: A Prospective Study
by
Al Farsi, Rajaa Saleh
,
Al Huraizi, Aisha Ramadhan
,
Al-Saadi, Taif
in
Cardiology
,
Clinical medicine
,
Clinical outcomes
2023
Background: Delirium is highly prevalent among elderly hospitalized patients in various healthcare settings. This study aimed to assess the impact of delirium on short- and long-term health outcomes. Methods: A prospective cohort included medically ill patients (≥65 years) admitted to a tertiary healthcare facility. Delirium was screened using the 3-Minute Diagnostic confusion assessment method (3D-CAM). Results: During hospitalization, 53.8% (n = 153/284) had delirium. Patients with delirium had a longer length of hospital stay (LOS) (7 vs. 5 days; p < 0.01) compared to patients without delirium. Delirium caused a higher frequency of high-dependency unit (HDU) or intensive care unit (ICU) admission (p < 0.01) and an increased incidence of hospital-acquired complications, including infections (p = 0.03), pressure injuries (p = 0.01), and upper gastrointestinal bleeding (p < 0.01). Inpatient all-cause mortality was higher in patients with delirium than those without delirium (16.3% vs. 1.5%; p < 0.01). Patients with delirium had higher rates of 90-day all-cause mortality (25.4% vs. 8.4%; p < 0.01) and 1-year all-cause mortality (35.9% vs. 16%; p < 0.01) compared to patients without delirium. Patients with delirium exhibited shorter survival periods at 90 days and 1 year compared to patients without delirium with a hazard ratio (HR) = 3.41, 95% CI: 1.75–6.66, p < 0.01 and HR = 2.64, 95% CI: 1.59–4.37, p < 0.01, respectively. Conclusions: Delirium is associated with serious short-term and long-term clinical consequences. Early recognition, prevention, and targeted interventions addressing reversible risk factors are crucial. Further research is warranted to explore effective strategies for delirium management in general medical wards.
Journal Article
Effect of melatonin versus placebo for prevention of delirium among medically hospitalised patients: study protocol for a single-centre, double-blinded, randomised controlled trial (project RESTORE)
by
Al Farsi, Rajaa Saleh
,
Al Huraizi, Aisha Ramadhan
,
Al-Busaidi, Salim
in
Aged
,
Aged, 80 and over
,
Circadian rhythm
2025
IntroductionDelirium, a common neuropsychiatric condition in hospitalised older adults, is associated with increased mortality, longer hospital stays and cognitive decline. The potential of melatonin to prevent delirium by improving sleep patterns and regulating circadian rhythms is promising, though existing evidence is mixed. This study aims to evaluate the efficacy of melatonin in preventing delirium in medically hospitalised patients aged 65 years and older.Methods and analysisThis randomised, double-blind, placebo-controlled trial will enrol 240 patients aged 65 or older admitted to general medical wards at Sultan Qaboos University Hospital starting from September 2024. Participants will be randomly assigned to receive either 5 mg or 8 mg of melatonin or a placebo nightly for up to 5 days. The primary outcome is the incidence of delirium, assessed using the 3 min Diagnostic Confusion Assessment Method during the first 5 days. Secondary outcomes include the duration of delirium, sleep patterns and other clinical measures, such as hospital length of stay and 28-day readmission.Ethics and disseminationThe study protocol has received ethical approval from the Medical Research Ethics Committee at Sultan Qaboos University (REF. NO. SQU-EC/024\\2024, MREC #3240). All participants or their legal proxies will provide informed consent prior to enrolment. Results will be disseminated through peer-reviewed publications and conference presentations, contributing to the global evidence base on delirium prevention strategies in hospitalised older adults.Trial registration numberClinicalTrials.gov under the identifier NCT06509191.
Journal Article
Symptoms-triggered approach versus fixed-scheduled approach of benzodiazepines for management of alcohol withdrawal syndrome: Non-randomized controlled trial
by
Al Alawi, Abdullah M.
,
Al-Maqbali, Juhaina Salim
,
Al-Mamari, Qasim
in
Alcohol
,
Alcohol withdrawal
,
Alcohol withdrawal syndrome
2023
Alcohol withdrawal syndrome, if untreated, can lead to potentially life-threatening complications. Benzodiazepines are the drugs of choice for the treatment of alcohol withdrawal syndrome. We aimed to compare the symptoms-triggered approach and fixed-dose approach of benzodiazepine administration for treatment of alcohol withdrawal syndrome in regard to the health care utilization measured by the total dose of benzodiazepines, length of hospital stays, and 90-day readmissions rate.
A single-center prospective non-randomized controlled trial included all patients diagnosed with alcohol withdrawal syndrome. The group of patients admitted between October 1, 2019, and September 30, 2020, were treated with the fixed-scheduled approach (n = 150), while all patients admitted between November 1, 2020, to October 31, 2021, were treated with the symptoms-trigger approach (n = 50).
The fixed-dose approach group showed a significant higher 90-day readmissions rate (HR: 2.61; 95% CI = 1.18, 6.84; p = 0.01). Kaplan–Meier survival analysis showed a significantly shorter duration to the first readmission in the fixed-scheduled approach group (HR: 2.3; 95% CI = 5.6, 1.16; p = 0.02). The symptoms-triggered approach group required a significantly lower dose of diazepam (40 mg vs. 10 mg; p < 0.01) and a higher dose of thiamine (800 mg vs. 600 mg; p < 0.01). Length of hospital stay was significantly increased in the symptoms-triggered approach group (3.9 vs. 2.2 days; p < 0.01).
The use of a symptoms-triggered approach to treat alcohol withdrawal syndrome was associated with a lower 90-day readmission rate, prolonged period to the first readmission, and reduced total dose of benzodiazepines, but longer length of hospital stays.
The symptoms-triggered approach is safe, cost-effective, and associated with reduced alcohol dependence relapse.
•The use of the symptoms-triggered approach for treatment of alcohol withdrawal syndrome was associated with reduction of 90-day readmissions, increased duration to the first readmission, and reduced the total dose of benzodiazepines.•Compared to fixed doses of benzodiazepam, the symptoms-triggered approach for treatment of alcohol withdrawal syndrome may increase length of hospital stay.•The use of the symptoms-triggered approach for treatment of alcohol withdrawal syndrome is safe and was not associated with increased in-hospital adverse events.
Journal Article