Optimal Dosage of Melatonin for Preoperative Sedation in FESS

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07550751

Acronym

FESS

Enrollment

160

Registered

2026-04-24

Start date

2024-08-01

Completion date

2025-10-01

Last updated

2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Trial

Brief summary

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

Interventions

DRUGMelatonin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Caregiver)

Intervention model description

randomized controlled trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	Questionnaire assessment of anxiety
Measuring heart rate in beat/min	Baseline and perioperative	Effect of preoperative different doses of melatonin on heart rate as a part of hemodynamic stability
Measuring blood pressure (systolic, diastolic and mean arterial pressure) in mmHg	Baseline and perioperative	Effect of preoperative different doses of melatonin on blood pressure as a part of hemodynamic stability
Measuring oxygen saturation (in percentage) using pulse oximeter	Baseline and perioperative	Effect of preoperative different doses of melatonin on oxygen saturation as a part of hemodynamic stability
Postoperative pain assessment using Visual Analogue score of pain	1,2,4and6 hours postoperative	Assessment of the effect of melatonin on postoperative pain management

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026