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Completed

NCT Number: NCT07550751

Optimal Dosage of Melatonin for Preoperative Sedation in FESS

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

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Key information

Conditions

Clinical Trial

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aswan university hospitals

Aswān, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Melatonin

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study title

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

Acronym: FESS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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