Status:

COMPLETED

Comparison Of The Effects Of Melatonin Premedication And Ketamine On Postoperative Sleep Quality İn Rhinoplasty

Lead Sponsor:

Konya City Hospital

Collaborating Sponsors:

necmettin erbakan university Scientific Research Projects (BAP)

Conditions:

Postoperative Sleep Disturbances

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

Brief Summary

Background Postoperative sleep disorders are common complications of surgery and anesthesia that prolong morbidity and hospital stay. Various methods are being explored to prevent and treat these issu...

Detailed Description

Participants Patients aged 18-65 years with an ASA score of I-II were included. Exclusion criteria were body mass index (BMI) ≥ 30 kg/m², obstructive sleep apnea syndrome (OSAS), psychiatric disorders...

Eligibility Criteria

Inclusion

  • Patients capable of providing consent
  • Patients able to reliably report their symptoms to the research team
  • Patients with American Society of Anesthesiologists (ASA) physical status I-II
  • Patients aged 18-65 years
  • Patients undergoing rhinoplasty surgery

Exclusion

  • Patients with cognitive impairment or a communication barrier
  • Patients with a BMI \> 30
  • Patients with OSAS (Obstructive Sleep Apnea Syndrome)
  • Patients with a known psychiatric disorder
  • Patients with renal failure
  • Patients with liver failure
  • Patients with cardiovascular disease (e.g., heart failure, coronary artery disease, arrhythmia, etc.)
  • Patients with malignancy
  • Patients who are pregnant or lactating
  • Patients with a history of allergy to melatonin and ketamine
  • Patients with an American Society of Anesthesiologists (ASA) Physical Status score ≥3
  • Patients who do not consent to participate in the study

Key Trial Info

Start Date :

September 19 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 25 2024

Estimated Enrollment :

183 Patients enrolled

Trial Details

Trial ID

NCT06898463

Start Date

September 19 2022

End Date

December 25 2024

Last Update

May 9 2025

Active Locations (1)

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Necmettin Erbakan University Faculty of Medicine

Konya, Selçuklu, Turkey (Türkiye), 42080