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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-02

Study Completion Date

2023-10-30

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.

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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.

Conditions

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Anxiety Preoperative Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

A 5mg vitamin B12 pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The placebo pill will be given to the patients 1 hour prior to their planned surgery.

Diazepam

A 5mg diazepam pill

Group Type ACTIVE_COMPARATOR

Diazepam

Intervention Type DRUG

Diazepam will be given to the patients 1 hour prior to their planned surgery.

Melatonin

A 5mg melatonin pill

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

Melatonin will be given to the patients 1 hour prior to their planned surgery.

Interventions

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Placebo

The placebo pill will be given to the patients 1 hour prior to their planned surgery.

Intervention Type DRUG

Diazepam

Diazepam will be given to the patients 1 hour prior to their planned surgery.

Intervention Type DRUG

Melatonin

Melatonin will be given to the patients 1 hour prior to their planned surgery.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No