Phase 3
Completed N=87
Comparing the Effect of Melatonin, Diazepam, and Placebo on Decreasing the Level of Anxiety Preoperatively
Source: ClinicalTrials.gov NCT06103188 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Change in the Anxiety Score Using the Visual Analogue Score for Anxiety Between Treatment Arms — 0; 0; 0 score on a scale
◆ Published Evidence
Emerging
1citation · ~1 / year
The efficacy of melatonin as a preoperative anxiolytic in real-world setting: a randomized controlled trial.
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.
Linked Publications
-
The efficacy of melatonin as a preoperative anxiolytic in real-world setting: a randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Anxiety Score Using the Visual Analogue Score for Anxiety Between Treatment Arms |
0; 0; 0 | — |
| PRIMARY Change in Anxiety Score Based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) Between Treatment Arms |
-0.5; -1; 0; 0; 0; 0 | — |
| SECONDARY Change in Sedation Between Treatment Arms |
0; 0; 0 | — |
| SECONDARY Change in Orientation Between Treatment Arms |
0; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06103188) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.