Comparison Of The Effects Of Melatonin Premedication And Ketamine On Postoperative Sleep Quality n Rhinoplasty
Status:
COMPLETED
Trial end date:
2024-12-25
Target enrollment:
Participant gender:
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.
Phase:
PHASE4
Details
Lead Sponsor:
Konya City Hospital
Collaborator:
necmettin erbakan university Scientific Research Projects (BAP)