NCT07550751

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

April 11, 2026

Last Update Submit

April 22, 2026

Conditions

Clinical Trial

Outcome Measures

Primary Outcomes (1)

  • preoperative sedation using ramsay sedation scale

    assess of sedation pre-induction of anesthesia and one hour after recovery

    just before intravenous anesthetic induction and one hour after recovery

Secondary Outcomes (5)

  • perioperative anxiety using The six-item State-Trait Anxiety Inventory (STAI-6) scale

    Baseline one hour before surgery, just before induction of anaesthesia and one hour after recovery

  • Measuring heart rate in beat/min

    Baseline and perioperative

  • Measuring blood pressure (systolic, diastolic and mean arterial pressure) in mmHg

    Baseline and perioperative

  • Measuring oxygen saturation (in percentage) using pulse oximeter

    Baseline and perioperative

  • Postoperative pain assessment using Visual Analogue score of pain

    1,2,4and6 hours postoperative

Study Arms (4)

A

OTHER

placebo

Drug: Melatonin

B

OTHER

Melatonin 3mg

Drug: Melatonin

C

OTHER

Melatonin 5mg

Drug: Melatonin

D

OTHER

Melatonin 10mg

Drug: Melatonin

Interventions

MelatoninDRUG

comparison between placebo and different melatonin doses(3-5-10 mg)

ABCD

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan university hospitals

Aswān, Egypt

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anesthesia, surgical intensive care unit and pain management resident doctor.

Study Record Dates

First Submitted

April 11, 2026

First Posted

April 24, 2026

Study Start

August 1, 2024

Primary Completion

April 30, 2025

Study Completion

October 1, 2025

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

EG(1)