The Efficacy of Oral Melatonin in Preventing Postoperative Delirium for Patients Undergoing Orthopedic Surgery Under General Anesthesia

Study Overview
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Brief Summary
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Postoperative delirium is a complication that should not be underestimated. As it elaborates many complications that could be avoided when an accurate assessment of the risk factors and interventional measures are taken appropriately when needed.

Detailed Description
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Delirium is a variation in concentration capabilities that occurs acutely in association with a disturbed level of consciousness. Delirium is more common in orthopaedic surgery patients than in general surgery patients. As delirium ratios range from 44% to 55% in hip surgery patients, otherwise only 10%-14% of general surgery patients. Several studies were carried out and found that melatonin levels correlate with the development of delirium postoperatively. This study was conducted to determine the efficacy of administering melatonin preoperatively in patients undergoing orthopedic surgery to prevent postoperative delirium.

Official Title
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The Efficacy of Oral Melatonin in Preventing Postoperative Delirium for Patients Undergoing Orthopedic Surgery Under General Anesthesia

Conditions
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Delirium, Anesthesia Emergence, Delirium

Intervention / Treatment
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* Drug: Melatonin
* Other: No intervention
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1- Patients in good general health. 2. Baseline MDAS <13. 3. No seizure disorder. Exclusion Criteria: Patients with a neurological disorder (e.g., dementia, stroke, epilepsy). Patients with a history of acute or chronic confusion. Patients taking centrally acting drugs (e.g., antidepressants, antiparkinsonian drugs, sedatives, monoamine oxidase inhibitors), or alcohol abusers. Patients who have medical disorders predisposing to delirium (e.g. cachexia, thyroid dysfunction, renal failure).

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were divided into three groups at random, with 12 patients in each group, using a double-blinded method.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Patients in this group received nothing for sedation. | Other: No intervention<br>* No intervention was used.<br>|
| Active Comparator: Midazolam group<br>7.5 mg of Midazolam were given orally the night before operation. Another dose 90 min. preoperatively. | Drug: Midazolam<br>* 7.5 mg of Midazolam orally.<br>|
| Experimental: Melatonin group<br>5 mg of Melatonin were given orally the night before operation. Another dose 90 min. preoperatively | Drug: Melatonin<br>* The patients were assessed using the Memorial Delirium Assessment Scale (MDAS) after the operation at 30, 60, and 90 min. Melatonin was shown to reduce delirium from 41.6% to 16.6% at 60 minutes, and the significant reduction was at 90 minutes (0%) when compared to both groups. Thus, melatonin was found to be successful in decreasing postoperative delirium when administered preoperatively.<br>* Other names: Midazolam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of oral Melatonin in preventing Postoperative Delirium after general anesthesia | This interventional trial is done to determine the efficacy of preoperative melatonin administration in reducing postoperative delirium rates. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, melatonin, patients, surgery, postoperative, benzodiazepines, orthopedic, preoperatively