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Melatonin to Decrease the Incidence of Postoperative Delirium in Geriatric Patients

NCT04483596 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-12-22

No results posted yet for this study

Summary

POD has been reported to be associated with a large number of risk factors: age as POD occurs in 10% to 61% of those aged 65 or older, dementia, impaired left ventricular function, electrolyte disorder, alcoholism, smoking, high perioperative transfusion requirements, intraoperative pressure fluctuation, and use of benzodiazepine POD occurs mostly in some types of surgery, such as orthopedic surgeries, major gastrointestinal surgery, and major cardiovascular surgeries, surgery under general anesthesia, prolonged surgery, emergency surgery

Previous studies done before to prove the efficacy of melatonin to decrease the incidence of postoperative delirium in patients with multiple risk factors for POD as traumatic geriatric patients were concerned only with the type of surgery as hip replacement or with spinal anesthesia but no study was done before to assess the prophylactic effect of melatonin to decrease the incidence of postoperative delirium in geriatric patients under general anesthesia ,which represents an independent risk factor for POD. So,this double blinded RCT will try to fill this gap in literature.

Conditions

  • Postoperative Delirium

Interventions

DRUG

melatonin effect on the Abbreviated Mental Test

Questionnare 1. Age 2. Time (to nearest hour) 3. Address for recall at end of test (Ask patient to repeat the address to ensure it has been heard correctly) 4. Year 5. Name of hospital 6. Recognition of two persons (e.g. doctor, nurse) 7. Date of birth 8. Year of any famous event e.g: the last Egyptian revolution 9. Name of the present monarch 10. Count backwards from 20 to 1

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-30
Primary Completion
2020-12-01
Completion
2020-12-03
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04483596 on ClinicalTrials.gov