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

Purpose:

Postoperative sleep disorders are common complications of surgery and anesthesia that increase morbidity and prolong hospital stay. Various methods are being explored to prevent and treat these issues. This study investigated the effects of melatonin and ketamine on postoperative sleep disturbances in patients undergoing rhinoplasty.

Method:

Based on a power analysis, 183 rhinoplasty patients were enrolled and randomized into three groups (n=61 each): Group M received 0.1 mg/kg oral melatonin pre- and postoperatively; Group K received 0.3 mg/kg IV ketamine intraoperatively; and Group MK received both regimens. Preoperative sleep quality was assessed using the RCSQ scale, and demographic data along with ASA scores were recorded. Intraoperative monitoring included baseline, post-intubation, and post-extubation vital parameters (HR, SAP, DAP, MAP), recorded at 30-minute intervals, as well as surgical and extubation times and remifentanil and sevoflurane consumption. Early complications during extubation (e.g., coughing, breath holding, desaturation, vomiting, laryngospasm) and later complications in the post-anesthesia care unit were documented. Patients' sleep quality was re-evaluated on the first postoperative day using the RCSQ and NRS scales.

Materials and Methods:

This prospective, randomized, and controlled study was conducted with the approval of the Necmettin Erbakan University Faculty of Medicine Ethics Committee, and informed consent was obtained from all patients. Patients aged 18-65 years with an ASA score of I-II were included. Patients with a body mass index (BMI) ≥30 kg/m², obstructive sleep apnea syndrome (OSAS), psychiatric disorders, renal failure, liver failure, cardiovascular disease, malignancy, pregnancy, or allergies to melatonin or ketamine were excluded.

The sample size was calculated as 180 patients to compare three groups, achieving 85% power, a 5% Type I error rate, and an effect size of 0.25. Patients were assigned to groups using a sealed opaque envelope technique. Sixty patients were planned per group, with three extra patients randomly assigned to the groups using a shuffle algorithm, resulting in 183 total participants.

Group 1 (Melatonin, M): received 0.1 mg/kg oral melatonin 60 minutes before surgery in the premedication room and again at 9 PM on the first postoperative day.

Group 2 (Ketamine, K): received 0.3 mg/kg IV ketamine during anesthesia induction.

Group 3 (Melatonin-Ketamine, MK): received both 0.1 mg/kg oral melatonin (as in Group 1) and 0.3 mg/kg IV ketamine (as in Group 2).

The same general anesthesia protocol was applied to all patients, and open rhinoplasty was performed by the same surgical team. Preoperative sleep quality on the night before surgery was assessed using the Richards-Campbell Sleep Questionnaire (RCSQ), and demographic data with ASA scores were recorded. In the premedication room, patients were sedated and then monitored in the operating room with ECG, SpO₂, non-invasive blood pressure (NIBP), and neuromuscular transmission (NMT).

Anesthesia induction was performed using intravenous propofol, lidocaine, and rocuronium. Maintenance was achieved with a continuous remifentanil infusion and 1 L/min sevoflurane inhalation. Dosages were adjusted to maintain heart rate (HR) and systolic arterial pressure (SAP) within 20-30% of baseline, with a target mean arterial pressure (MAP) \>50 mmHg and surgical pleth index (SPI) of 40-60. HR, SAP, diastolic arterial pressure (DAP), and MAP were recorded at baseline, post-intubation, every 30 minutes, and post-extubation.

Before the end of surgery, intravenous tramadol and paracetamol were administered for analgesia, and ondansetron was given to prevent nausea and vomiting. After extubation, total remifentanil and sevoflurane consumption (in milliliters), surgical duration, and extubation time (measured from cessation of anesthetic agents to awakening) were recorded.

In the post-anesthesia care unit (PACU), modified Aldrete scores and the time to reach those scores were documented, along with numeric rating scale (NRS) pain scores at the first postoperative hour. On postoperative day one, sleep quality was reassessed using the RCSQ, and NRS scores were re-evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 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 Criteria:
* 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