Melatonin to Decrease the Incidence of Postoperative Delirium in Geriatric Patients

NCT04483596 | Completed FDA Drug

• 1 other identifier: MS-103-2020
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

melatonin; delirium; geriatrics; general anesthesia

Outcome Measures

Primary Outcomes (1)

• postoperative delirium

  Detection of the difference in incidence of POD between melatonin group and control group using the Abbreviated Mental Test (AMT)

  3 postoperative days

Study Arms (2)

M

will receive 5 mg melatonin orally at 9 p.m. the night before surgery and another 5 mg melatonin with 15 ml of plain water 30 min before operation and 5 mg melatonin at 9 p.m. in the day of operation and for the first three postoperative days

Drug: melatonin effect on the Abbreviated Mental Test

C

received a placebo in the form of one tablet of 500 mg paracetamol that packaged the same way as melatonin at the same times

Drug: melatonin effect on the Abbreviated Mental Test

Interventions

melatonin effect on the Abbreviated Mental Test DRUG

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

C; M

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

geriatric patients undergoing surgeries under general anesthesia

You may qualify if:

• ASA physical status I-II

You may not qualify if:

• ASA physical status ≥ III.
• Allergy to the study drugs or one of their ingredients
• Patients with Abbreviated Mental Test (AMT) score of\< 6 ,
• illiterate people,
• preoperative sedation score \>4,
• History of alcohol abuse,
• Sensory impairment (blindness, deafness),
• Severe anemia (hematocrit\<27%),
• Intracranial events (stroke, bleeding, infection),
• Fluid or electrolyte disturbances including dehydration, hyponatremia, hypernatremia,
• Acute cardiac events: myocardial infarction, congestive heart failure exacerbation, arrhythmia,
• Acute pulmonary events: asthma or chronic obstructive pulmonary disease exacerbation, pulmonary embolism, hypoxemia, hypercarbia -,Medications Anticonvulsants, Antidepressants, Antihistamines, Antiparkinsonian agents, Antipsychotics. And history of chronic sedative hypnotic use \>3 times/week during a month prior to surgery

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University hospitals

Cairo, Manial, 12511, Egypt

Location

Related Publications (1)

• Jankowski CJ, Trenerry MR, Cook DJ, Buenvenida SL, Stevens SR, Schroeder DR, Warner DO. Cognitive and functional predictors and sequelae of postoperative delirium in elderly patients undergoing elective joint arthroplasty. Anesth Analg. 2011 May;112(5):1186-93. doi: 10.1213/ANE.0b013e318211501b. Epub 2011 Mar 17.

  PMID: 21415433 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium; Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 23, 2020
• Study Start: July 30, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 3, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)