Comparing the Effect of Melatonin, Diazepam, and Placebo on Decreasing the Level of Anxiety Preoperatively

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the effect of melatonin, diazepam, and placebo on the level of anxiety in patients undergoing surgery. The main question it aims to answer is: • Is melatonin effective in reducing the anxiety of patients undergoing surgery? Participants will be asked to answer a questionnaire then they will receive either melatonin, diazepam, or placebo, and then after an hour, they will answer the same questionnaire again. Researchers will compare melatonin, diazepam, and placebo to see if melatonin is as effective in reducing the level of anxiety as diazepam in patients undergoing surgery.

Detailed Description
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Anxiety is a tense unpleasant sensation experienced by many individuals secondary to their concerns or due to the anticipation of an unpleasant experience like a surgery. Even with the advancement of medical treatment, preoperative anxiety remains a widespread complaint that affects the patients psychologically and physically, and at the same time adversely affecting the outcome of the operation and the experience of the patient. In this triple-blind, randomized clinical study, we aim to compare melatonin to diazepam regarding its efficacy in reducing preoperative anxiety, as well as assessing multiple other effects such as sedation, orientation, and cognition, by applying validated tools to patients undergoing elective surgeries before and after administering the premedication.

Official Title
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Comparing Melatonin to Diazepam as a Premedication: a Triple-blind, Randomized, Placebo Controlled Clinical Trial

Conditions
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Anxiety, Preoperative Anxiety

Intervention / Treatment
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* Drug: Placebo
* Drug: Diazepam
* Drug: Melatonin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 1 or 2 Posted for general anesthesia Aging between 18 and 65 years Exclusion Criteria: Allergy to any of the drugs under study Pregnancy Illiteracy Any mental illness Taking antipsychotics, antidepressants, anxiolytics, or sedatives

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>A 5mg vitamin B12 pill | Drug: Placebo<br>* The placebo pill will be given to the patients 1 hour prior to their planned surgery.<br>|
| Active Comparator: Diazepam<br>A 5mg diazepam pill | Drug: Diazepam<br>* Diazepam will be given to the patients 1 hour prior to their planned surgery.<br>|
| Experimental: Melatonin<br>A 5mg melatonin pill | Drug: Melatonin<br>* Melatonin will be given to the patients 1 hour prior to their planned surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the anxiety score using the visual analogue score for anxiety between treatment arms | VAS (Visual Analogue Score) Anxiety Scale is a 100 mm long scale. The scale is marked in millimeters from 0 to 100, where 0 correlates with no anxiety at all, and 100 correlates to anxiety as bad as possible. The maximum score is 100 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The more the reduction in anxiety from baseline, the better the outcome. | Before administration of premedication, and after 1 hour from the administration of the premedication. | 
| Change in anxiety score based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) between treatment arms | The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a self-reported questionnaire. The scale consists of six items, four of which assess the patient's anxiety, while the last two assess the patients' need-for-information and the patient must choose how much he agrees with each item on a scale of 1 (not at all) to 5 (very much). The more the reduction in the anxiety score from baseline the better the outcome. | Before administration of premedication, and after 1 hour from the administration of the premedication. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sedation between treatment arms | Sedation will be assessed with Ramsay sedation scale (RSS) as follows: - Patient is anxious and agitated or restless, or both - Patient is cooperative, oriented, and tranquil - Patient responds to commands only - Patient exhibits brisk response to light glabellar tap or loud auditory stimulus - Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus - Patient exhibits no response. | Before administration of premedication, and after 1 hour from the administration of the premedication. | 
| Change in orientation between treatment arms | Orientation will be assessed with a three-point scale as follows: 0 - None - Orientation in either time or place - Orientation in both | Before administration of premedication, and after 1 hour from the administration of the premedication. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative anxiety, Anxiolytic, Melatonin, Diazepam, Sedation, Premedication