Sublingual Melatonin for Anxiety and Pain in Elective Gynecologic Surgery

Benha University

Status: Completed

Conditions: Postoperative Pain; Anxiety; Anesthesia

Treatments: Drug: Melatonin 6 mg Sublingual; Drug: Melatonin 3 mg Sublingual

Study type: Interventional

Funder types: Other

Identifiers

NCT06997263

MS 25-03-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 3 patient groups

Low-Dose Melatonin Group

Experimental group

Description:

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.

Treatment:

Drug: Melatonin 3 mg Sublingual

High-Dose Melatonin Group

Experimental group

Description:

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.

Treatment:

Drug: Melatonin 6 mg Sublingual

Control Grou

No Intervention group

Description:

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