Optimal Dosage of Melatonin for Preoperative Sedation in FESS (FESS)

April 22, 2026 updated by: Osaid Abdelshakour Elsayed Abdallah, Aswan University Hospital

Optimal Melatonin Dosage for Effective Sedation, Hemodynamic Stability and Pain Control in Functional Endoscopic Sinus Surgery (FESS)

To determine the optimal dosage of Melatonin for preoperative sedation in patients undergoing FESS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Aswān, Egypt
        • Aswan university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- ASA 1 ASA 2 patients scheduled for elective FESS under general anesthesia

Exclusion Criteria:

  • hypersensitivity or contraindication to the drug
  • Severe psychiatric disorders.
  • Regular use of sedatives or analgesics.
  • Pregnancy or breastfeeding
  • Significant systemic diseases such as severe cardiovascular, hepatic, or renal dysfunction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A
placebo
Drug: Melatonin
comparison between placebo and different melatonin doses(3-5-10 mg)
Other: B
Melatonin 3mg
Drug: Melatonin
comparison between placebo and different melatonin doses(3-5-10 mg)
Other: C
Melatonin 5mg
Drug: Melatonin
comparison between placebo and different melatonin doses(3-5-10 mg)
Other: D
Melatonin 10mg
Drug: Melatonin
comparison between placebo and different melatonin doses(3-5-10 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
preoperative sedation using ramsay sedation scale
Time Frame: just before intravenous anesthetic induction and one hour after recovery
assess of sedation pre-induction of anesthesia and one hour after recovery
just before intravenous anesthetic induction and one hour after recovery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
perioperative anxiety using The six-item State-Trait Anxiety Inventory (STAI-6) scale
Time Frame: Baseline one hour before surgery, just before induction of anaesthesia and one hour after recovery
Questionnaire assessment of anxiety
Baseline one hour before surgery, just before induction of anaesthesia and one hour after recovery
Measuring heart rate in beat/min
Time Frame: Baseline and perioperative
Effect of preoperative different doses of melatonin on heart rate as a part of hemodynamic stability
Baseline and perioperative
Measuring blood pressure (systolic, diastolic and mean arterial pressure) in mmHg
Time Frame: Baseline and perioperative
Effect of preoperative different doses of melatonin on blood pressure as a part of hemodynamic stability
Baseline and perioperative
Measuring oxygen saturation (in percentage) using pulse oximeter
Time Frame: Baseline and perioperative
Effect of preoperative different doses of melatonin on oxygen saturation as a part of hemodynamic stability
Baseline and perioperative
Postoperative pain assessment using Visual Analogue score of pain
Time Frame: 1,2,4and6 hours postoperative
Assessment of the effect of melatonin on postoperative pain management
1,2,4and6 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aswan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

October 1, 2025

Study Registration Dates

First Submitted

April 11, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Asw.Uni. / 965 / 9 / 24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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