Clinical trial NCT06103188: Comparing the Effect of Melatonin, Diazepam, and Placebo on Decreasing the Level of Anxiety Preoperatively
Official title: Comparing Melatonin to Diazepam as a Premedication: a Triple-blind, Randomized, Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety
Preoperative Anxiety
Keywords: Preoperative anxiety
Anxiolytic
Melatonin
Diazepam
Sedation
Premedication
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Change in the Anxiety Score Using the Visual Analogue Score for Anxiety Between Treatment Arms
timeFrame: Before administration of premedication, and after 1 hour from the administration of the premedication.
measure: Change in Anxiety Score Based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) Between Treatment Arms
timeFrame: Before administration of premedication, and after 1 hour from the administration of the premedication.
Secondary outcomes:
measure: Change in Sedation Between Treatment Arms
timeFrame: Before administration of premedication, and after 1 hour from the administration of the premedication.
measure: Change in Orientation Between Treatment Arms
timeFrame: Before administration of premedication, and after 1 hour from the administration of the premedication.
Other outcomes:
measure: Change in the Anxiety Score Using the Visual Analogue Score for Anxiety Between Genders
timeFrame: Before administration of premedication, and after 1 hour from the administration of the premedication.
measure: Change in Anxiety Score Based on The Amsterdam Preoperative Anxiety and Information Scale (APAIS) Between Genders
timeFrame: Before administration of premedication, and after 1 hour from the administration of the premedication.
measure: Change in Sedation Between Genders
timeFrame: Before administration of premedication, and after 1 hour from the administration of the premedication.
measure: Change in Orientation Between Genders
timeFrame: Before administration of premedication, and after 1 hour from the administration of the premedication.
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
Study officials:
affiliation: University of Jordan
name: Omar Ismail
role: PRINCIPAL_INVESTIGATOR
References: