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

NCT06898463 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2025-05-09

No results posted yet for this study

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 issues. This study was designed to investigate the effects of ketamine, melatonin, and their combination on postoperative sleep disturbances and pain.

Methods Patients were randomly allocated into three groups: melatonin (Group M), ketamine (Group K), and a melatonin-ketamine combination (Group MK). Group M received 0.1 mg/kg oral melatonin preoperatively (60 minutes before surgery) and postoperatively at 21:00; Group K received 0.3 mg/kg IV ketamine during anesthesia induction; and Group MK received both regimens. Sleep quality was assessed on the first postoperative day using the Richards-Campbell Sleep Questionnaire (RCSQ), and pain intensity was evaluated with the Numeric Rating Scale (NRS). Early extubation-related complications (e.g., coughing, breath-holding, desaturation, vomiting, and laryngospasm) and delayed complications in the post-anesthesia care unit (PACU) were documented. Demographic variables, including ASA physical status scores, were recorded. Intraoperative monitoring comprised basal, post-intubation, and post-extubation measurements of heart rate (HR), systolic arterial pressure (SAP), diastolic arterial pressure (DAP), and mean arterial pressure (MAP) at 30-minute intervals, together with recording surgery and extubation durations.

Conditions

  • Postoperative Sleep Disturbances

Interventions

DRUG

Melatonin (N-acetyl-5-methoxytryptamine)

0.1 mg/kg oral melatonin was administered twice

DRUG

Ketamine

0.3 mg/kg intravenous ketamine was administered during anesthesia induction.

Sponsors & Collaborators

  • necmettin erbakan university Scientific Research Projects (BAP)

    collaborator UNKNOWN

  • Konya City Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-19
Primary Completion
2024-05-25
Completion
2024-12-25

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06898463 on ClinicalTrials.gov