Clinical trial NCT06997263: Sublingual Melatonin for Anxiety and Pain in Elective Gynecologic Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Postoperative Pain
Anesthesia
Keywords: Melatonin
Sublingual Melatonin
Hysterectomy
Ovarian Cystectomy
Myomectomy
Anxiety Reduction
Pain Management
Premedication
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 .

Primary outcomes:
measure: Change in Preoperative Anxiety Score (BAI)
timeFrame: At baseline (preoperative), at recovery (0 hours), and at 12 hours postoperatively
Secondary outcomes:
measure: Postoperative Pain Intensity
timeFrame: At 0, 1, 4, 12, and 24 hours postoperatively
measure: Time to First Rescue Analgesia Request
timeFrame: Up to 24 hours postoperatively
measure: Cumulative Postoperative Opioid Consumption
timeFrame: From Post-Anesthesia Care Unit (PACU) admission to 24 hours postoperatively
measure: Post-Anesthesia Care Unit (PACU) Discharge Time
timeFrame: Immediately postoperatively, assessed up to 2 hours
measure: Length of Hospital Stay
timeFrame: From end of surgery to hospital discharge, typically 1-3 days
Other outcomes:
Locations:
city: Banha
country: Egypt
facility: Benha University
state: Qualiobia
Study officials:
References: