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NCT Number: NCT06997263

Sublingual Melatonin for Anxiety and Pain in Elective Gynecologic Surgery

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Benha University

Banhā, Qualiobia, 13518, Egypt

About this study

Elective gynecological surgery plays a vital role in women's healthcare, addressing a wide range of medical conditions from benign disorders to oncological diseases. Despite its importance, these procedures often lead to significant preoperative anxiety and postoperative pain, which can adversely affect patient recovery and satisfaction. The psychological impact is particularly prominent in gynecologic surgeries due to factors such as loss of fertility, body image concerns, and invasiveness of the procedures.

The perioperative period is a time of heightened vulnerability, with anxiety potentially leading to physiological stress responses that may compromise surgical outcomes and increase morbidity. Common sources of this anxiety include fear of anesthesia, postoperative pain, surgical failure, and loss of personal control.

To address these concerns, various pharmacologic agents such as benzodiazepines, non-steroidal anti-inflammatory drugs, and opioids have been used. However, these drugs may have limitations or side effects. Recently, melatonin, a naturally occurring hormone involved in regulating the sleep-wake cycle, has been proposed as a promising alternative due to its anxiolytic and analgesic effects. It is considered safe, well-tolerated, and easy to administer.

Sublingual melatonin offers advantages such as rapid absorption and good bioavailability, making it a practical option for preoperative use. This study will explore the comparative efficacy of two different sublingual doses of melatonin on reducing anxiety and postoperative pain in women undergoing elective gynecologic surgery under general anesthesia.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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 .

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Preoperative Anxiety Score (BAI)

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

    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.

Secondary outcomes

  1. Postoperative Pain Intensity

    Time frame: At 0, 1, 4, 12, and 24 hours postoperatively

    Pain will be assessed using the Numerical Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Patients will verbally rate their pain at multiple postoperative time points.

  2. Time to First Rescue Analgesia Request

    Time frame: Up to 24 hours postoperatively

    Duration of postoperative analgesia will be measured as the time from Post-Anesthesia Care Unit (PACU) recovery to the first request for rescue analgesia (morphine), indicating when pain relief wears off.

  3. Cumulative Postoperative Opioid Consumption

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

    The total dose of intravenous morphine (mg) administered within the first 24 hours post-surgery to manage postoperative pain.

  4. Post-Anesthesia Care Unit (PACU) Discharge Time

    Time frame: Immediately postoperatively, assessed up to 2 hours

    Time from surgery completion until the patient achieves an Aldrete Recovery Score ≥8, which qualifies them for discharge from Post-Anesthesia Care Unit (PACU). The score assesses activity, respiration, circulation, consciousness, and oxygen saturation (max score = 10).

  5. Length of Hospital Stay

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

    Total time the patient remains hospitalized post-surgery until discharge.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Comparison Between Two Different Doses of Sublingual Melatonin to Alleviate Anxiety and Pain Associated With Elective Gynecological Surgeries Under General Anesthesia: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 30, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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