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

NCT06103188 | Completed Phase 3 Results DMC

• 1 other identifier: M001
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Preoperative Anxiety

Keywords

Preoperative anxiety; Anxiolytic; Melatonin; Diazepam; Sedation; Premedication

Outcome Measures

Primary Outcomes (2)

• 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 scores of each item are summed to provide the total score. The minimum score possible is 6 and the maximum score is 30, the higher the score the higher the anxiety level and need for information. The scale consists of two subscales: Need for Information subscale: consists of two items (minimum score of 2 and maximum score of 10, the higher the score the more need for information). Anxiety subscale: consists of four items (minimum score of 4 and maximum score of 20, the higher the score the higher the anxiety level). The total scale is the sum of the two subscales.

  Before administration of premedication, and after 1 hour from the administration of the premedication.

Secondary Outcomes (2)

• Change in Sedation Between Treatment Arms

  Before administration of premedication, and after 1 hour from the administration of the premedication.

• Change in Orientation Between Treatment Arms

  Before administration of premedication, and after 1 hour from the administration of the premedication.

Other Outcomes (4)

• Change in the Anxiety Score Using the Visual Analogue Score for Anxiety Between Genders

  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

  Before administration of premedication, and after 1 hour from the administration of the premedication.

• Change in Sedation Between Genders

  Before administration of premedication, and after 1 hour from the administration of the premedication.

Study Arms (3)

Placebo

PLACEBO COMPARATOR

A 5mg vitamin B12 pill

Drug: Placebo

Diazepam

ACTIVE COMPARATOR

A 5mg diazepam pill

Drug: Diazepam

Melatonin

EXPERIMENTAL

A 5mg melatonin pill

Drug: Melatonin

Interventions

Placebo DRUG

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

Placebo

Diazepam DRUG

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

Diazepam

Melatonin DRUG

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

Melatonin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1 or 2
• Posted for general anesthesia
• Aging between 18 and 65 years

You may not qualify if:

• Allergy to any of the drugs under study
• Pregnancy
• Illiteracy
• Any mental illness
• Taking antipsychotics, antidepressants, anxiolytics, or sedatives

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Jordan University Hospital

Amman, Jordan

Location

Related Publications (1)

• Ismail O, Albdour K, Jaber K, Jaber Y, Alsaras A, Younis A, Froukh U, Momani Y, Abu-Halaweh S. The efficacy of melatonin as a preoperative anxiolytic in real-world setting: a randomized controlled trial. Hosp Pract (1995). 2025 Feb;53(1):2600245. doi: 10.1080/21548331.2025.2600245. Epub 2025 Dec 9.

  PMID: 41346130 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Diazepam; Melatonin

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tryptamines; Indoles; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr Omar Ismail
• Organization: Jordan University Hospital

omar.moh.isml@gmail.com

+962791301329

Study Officials

• Omar Ismail

  University of Jordan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 21, 2023
• First Posted: October 26, 2023
• Study Start: October 2, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: January 24, 2025
• Results First Posted: January 24, 2025

Record last verified: 2024-12

Locations

JO (1)