Sublingual Melatonin for Anxiety and Pain in Elective Gynecologic Surgery

Benha University96 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Anxiety Postoperative Pain Anesthesia

Interventions

Melatonin 3 mg SublingualDRUG

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 SublingualDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 .

Locations (1)

Benha University

Banhā, Qualiobia, Egypt

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Postoperative Pain Intensity

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.

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

Time to First Rescue Analgesia Request

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.

Time frame: Up to 24 hours postoperatively

Cumulative Postoperative Opioid Consumption

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

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

Post-Anesthesia Care Unit (PACU) Discharge Time

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).

Time frame: Immediately postoperatively, assessed up to 2 hours

Length of Hospital Stay

Data from ClinicalTrials.gov

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