NCT06997263

Sublingual Melatonin for Anxiety and Pain in Elective Gynecologic Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Anxiety
• Postoperative Pain
• Anesthesia

Interventions

Type	Name	Description
DRUG	Melatonin 3 mg Sublingual	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.
DRUG	Melatonin 6 mg Sublingual	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.

Timeline

• Start date: 2024-01-15
• Primary completion: 2025-01-10
• Completion: 2025-01-15
• First posted: 2025-05-30
• Last updated: 2025-06-11

Locations

1 site across 1 country: Egypt