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

NCT06898463 | Completed Phase 4

• 1 other identifier: 2022/927
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

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 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

Keywords

Rhinoplasty; Sleep Disorder; Melatonin; Ketamine

Outcome Measures

Primary Outcomes (1)

• To compare the effects of melatonin and ketamine on postoperative sleep disturbances.

  On postoperative day 1, patients' sleep quality was assessed at bedside using the Richards-Campbell Sleep Questionnaire (RCSQ). Although primarily used in intensive care settings, the RCSQ is also valid for assessing sleep in postoperative patients. It shows high internal consistency and moderate correlation with polysomnography. The RCSQ includes five items: sleep depth, latency, awakenings, efficiency, and overall quality. Each item is rated on a 0-100 mm visual analog scale, where higher scores reflect better sleep. The total score is the average of the five items.

  From enrollment to the end of treatment at 21 Mounths

Study Arms (3)

M GROUP

ACTIVE COMPARATOR

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

Drug: Melatonin (N-acetyl-5-methoxytryptamine)

K GROUP

ACTIVE COMPARATOR

In Group 2 (Ketamine, K), patients were administered 0.3 mg/kg intravenous ketamine during anesthesia induction.

Drug: Ketamine

M-K GROUP

ACTIVE COMPARATOR

In Group 3 (Melatonin-Ketamine, MK), patients received 0.1 mg/kg oral melatonin in the premedication room 60 minutes before surgery and at 9:00 PM on the first postoperative day, and 0.3 mg/kg intravenous ketamine during anesthesia induction.

Drug: Melatonin (N-acetyl-5-methoxytryptamine); Drug: Ketamine

Interventions

Melatonin (N-acetyl-5-methoxytryptamine) DRUG

0.1 mg/kg oral melatonin was administered twice

M GROUP; M-K GROUP

Ketamine DRUG

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

K GROUP; M-K GROUP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya City Hospital: lead
• necmettin erbakan university Scientific Research Projects (BAP): collaborator

Study Sites (1)

Necmettin Erbakan University Faculty of Medicine

Konya, Selçuklu, 42080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

Melatonin; Ketamine

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator MD

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 27, 2025
• Study Start: September 19, 2022
• Primary Completion: May 25, 2024
• Study Completion: December 25, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting in March 2025

Locations

TU (1)