Melatonin for Post Operative Delirium Prevention in Elderly Patients

Study Overview
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Brief Summary
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The present study will evaluate the role of melatonin prophylaxis in delirium prevention in elderly patients undergoing colorectal procedures.

Detailed Description
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This study is a prospective randomised double-blind placebo-controlled trial. Patients who meet the criteria for inclusion/exclusion will be evaluated. Melatonin tablets will be administered as a premedication to patients in the melatonin group. Patients in the control group will be given placebo tablets as a premedication. Fentanyl 1ug/kg and propofol 1-2 mg/kg will be used to induce anaesthesia. Atracurium 0.5 mg/kg will be used for the facilitation of endotracheal intubation. Isoflurane will be used to maintain anaesthesia and the depth of anaesthesia will be adjusted by a Bispectral index monitor. Postoperatively, the patients will be monitored for the development of delirium.

Official Title
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The Impact of Melatonin on the Postoperative Delirium in Geriatric Patients After Colorectal Surgeries. A Randomised Placebo-controlled Trial

Conditions
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Delirium in Old Age

Intervention / Treatment
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* Drug: Melatonin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anaesthesiologists (ASA) I to III physical status Elective colorectal procedures Exclusion Criteria: Allergy to the research drugs, Patients who have vision or hearing impairment History of cerebral disorders Uncorrected acid-base, fluid, and electrolyte abnormalities History of central nervous system function affecting drugs. Chronic sedative-hypnotic administration at least one month prior to surgery Alcohol abuse Patients with recorded preoperative nursing delirium screening score ≥ 2.

Ages Eligible for Study
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Minimum Age: 65 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Melatonin group<br>The patients will be given 5 mg melatonin the night before surgery, 12 hours before the scheduled time of surgery, followed by another 5 mg melatonin two hours before surgery. | Drug: Melatonin<br>* The patients will be given 5 mg melatonin the night before surgery, 12 hours before the scheduled time of surgery, followed by another 5 mg melatonin two hours before surgery.<br>|
| Placebo Comparator: Control group<br>The patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group. | Drug: Placebo<br>* The patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of delirium occurrence | Nursing delirium - screening score. It scores five items,Each item is rated from 0 to 2 where 0, absent; 1, mild; 2, severe. A score ≥ 2 is considered to have delirium. | Perioperative. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of Sedation | Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation | Perioperative. | 
| Intensity of pain | Pain Assessment in Advanced Dementia Scale from 0 to 10 . score 1 to 3=mild pain; 4 to 6=moderate pain; 7-to 10=severe pain. | Perioperative | 
| Mean arterial blood pressure | mmHg | Perioperative | 
| Heart rate | beats/minute | Perioperative | 
| Hypotension | Number of patients with hypotension | Perioperative | 
| Hypoxia | Number of patients with hypoxia | Perioperative | 
| Blood transfusion needs | Number of patients needed blood transfusion | Perioperative |