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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Dose Melatonin Group | Experimental | 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. |
|
| High-Dose Melatonin Group | Experimental | 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. |
|
| Control Grou | No Intervention | Participants in this group will receive no premedication with anxiolytic drugs prior to surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin 3 mg Sublingual | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline (preoperative), at recovery (0 hours), and at 12 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 0, 1, 4, 12, and 24 hours postoperatively |
| Time to First Rescue Analgesia Request |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha University | Banhā | Qualiobia | 13518 | Egypt |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| D000286 | Administration, Sublingual |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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The outcomes assessor who will collect postoperative anxiety and pain data will be blinded to group assignments to minimize assessment bias. Participants, care providers, and investigators will not be blinded due to the nature of the intervention and its method of administration.
| Melatonin 6 mg Sublingual | 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. |
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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. |
| 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. | 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). | Immediately postoperatively, assessed up to 2 hours |
| Length of Hospital Stay | Total time the patient remains hospitalized post-surgery until discharge. | From end of surgery to hospital discharge, typically 1-3 days |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000284 | Administration, Oral |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |