Sublingual Melatonin for Anxiety and Pain in Elective Gynecologic Surgery

NCT ID: NCT06997263

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2025-01-15

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Low-Dose Melatonin Group

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.

Group Type: EXPERIMENTAL

Melatonin 3 mg Sublingual

Intervention Type: 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.

High-Dose Melatonin Group

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.

Group Type: EXPERIMENTAL

Melatonin 6 mg Sublingual

Intervention Type: 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.

Control Grou

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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 .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Mariam AbdAllah Ahmed

Resident of Anesthesia, Surgical Intensive Care and Pain Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Benha University

Banhā, Qualiobia, Egypt

Countries

Egypt

Other Identifiers

MS 25-03-2025

Identifier Type: -

Identifier Source: org_study_id