Sublingual Melatonin for Anxiety and Pain in Elective Gynecologic Surgery

NCT06997263 | Completed

• 1 other identifier: MS 25-03-2025
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized controlled study aims to evaluate the anxiolytic effect of preoperative sublingual melatonin and its impact on postoperative pain scores when administered in two different doses to female patients undergoing elective gynecological surgeries.

Conditions

Anxiety; Postoperative Pain; Anesthesia

Keywords

Melatonin; Sublingual Melatonin; Hysterectomy; Ovarian Cystectomy; Myomectomy; Anxiety Reduction; Pain Management; Premedication

Outcome Measures

Primary Outcomes (1)

• Change in Preoperative Anxiety Score (BAI)

  Anxiety will be assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire. Each item is rated on a 4-point Likert scale (0-3), with total scores ranging from 0 to 63. Higher scores indicate more severe anxiety.

  At baseline (preoperative), at recovery (0 hours), and at 12 hours postoperatively

Secondary Outcomes (5)

• Postoperative Pain Intensity

  At 0, 1, 4, 12, and 24 hours postoperatively

• Time to First Rescue Analgesia Request

  Up to 24 hours postoperatively

• Cumulative Postoperative Opioid Consumption

  From Post-Anesthesia Care Unit (PACU) admission to 24 hours postoperatively

• Post-Anesthesia Care Unit (PACU) Discharge Time

  Immediately postoperatively, assessed up to 2 hours

• Length of Hospital Stay

  From end of surgery to hospital discharge, typically 1-3 days

Study Arms (3)

Low-Dose Melatonin Group

EXPERIMENTAL

Participants in this group will receive 3 mg of sublingual melatonin the night before surgery and another 3 mg 1 hour before induction of general anesthesia.

Drug: Melatonin 3 mg Sublingual

High-Dose Melatonin Group

EXPERIMENTAL

Participants in this group will receive 6 mg of sublingual melatonin the night before surgery and another 6 mg 1 hour before induction of general anesthesia.

Drug: Melatonin 6 mg Sublingual

Control Grou

NO INTERVENTION

Participants in this group will receive no premedication with anxiolytic drugs prior to surgery.

Interventions

Melatonin 3 mg Sublingual DRUG

A single 3 mg dose of sublingual melatonin will be administered the night before surgery and repeated 1 hour before anesthesia induction in participants randomized to the Low-Dose Melatonin Group.

Low-Dose Melatonin Group

Melatonin 6 mg Sublingual DRUG

A single 6 mg dose of sublingual melatonin will be administered the night before surgery and repeated 1 hour before anesthesia induction in participants randomized to the High-Dose Melatonin Group.

High-Dose Melatonin Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patient scheduled for open elective gynecological surgeries (hysterectomy, ovarian cystectomy, myomectomy)
• Age 18-65 y
• American Society of Anesthesiologists (ASA) physical status (ASA I -II)

You may not qualify if:

• Patients with a history of uncontrolled hypertension
• Ischemic heart disease
• Uncontrolled diabetes
• Bronchial asthma
• Psychiatric illness
• Sleep disorders
• Obesity (Body mass index \>30 kg/m2)
• Patients taking antipsychotic, antidepressants, sedatives, anxiolytics, and anti-epileptic drugs.
• Pregnant and lactating females .

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, Qualiobia, 13518, Egypt

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain, Postoperative; Agnosia

Interventions

Melatonin; Administration, Sublingual

Condition Hierarchy (Ancestors)

Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Administration, Oral; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor who will collect postoperative anxiety and pain data will be blinded to group assignments to minimize assessment bias. Participants, care providers, and investigators will not be blinded due to the nature of the intervention and its method of administration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, Surgical Intensive Care and Pain Management

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: May 30, 2025
• Study Start: January 15, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 15, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

EG (1)