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

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Preoperative Anxiety
• Intervention / Treatment: Drug: Placebo; Drug: Diazepam; Drug: Melatonin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 3

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan
    • Jordan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the anxiety score using the visual analogue score for anxiety between genders	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 genders	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.
Change in sedation between genders	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 genders	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.

Collaborators and Investigators

• Sponsor: University of Jordan
• Investigators: Principal Investigator: Omar Ismail, University of Jordan

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Actual): October 19, 2023
• Study Completion (Actual): October 19, 2023

Study Registration Dates

• First Submitted: October 21, 2023
• First Submitted That Met QC Criteria: October 21, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Melatonin; Sedation; Diazepam; Premedication; Preoperative anxiety; Anxiolytic
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antiemetics; Gastrointestinal Agents; Protective Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Antioxidants; Neuromuscular Agents; Muscle Relaxants, Central; Melatonin; Diazepam
• Other Study ID Numbers: M001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No