Melatonin vs Gabapentin for Post Trauma Surgery

Study Overview
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Brief Summary
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This project aims to compare the effect of preoperative administration of melatonin and gabapentin in reducing preoperative anxiety, stress markers and postoperative pain levels in trauma patients undergoing surgery. Gabapentin has analgesic as well as sedative properties. Melatonin, a hormone has been extensively used in intensive care units and has found to improve the sleep cycle and reduce pain. It is now being explored as a preoperative medication.

Official Title
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A Comparative Study of Melatonin and Gabapentin as Premedication for Patients Undergoing Surgery Following Trauma

Conditions
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Anxiety, Preoperarative

Intervention / Treatment
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* Drug: Melatonin 6 MG
* Drug: Gabapentin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients will be recruited if they satisfy the following inclusion criteria: Age 18-65 years, ASA score I-II, Scheduled either for non-emergency surgery after trauma and Presumptive duration of operation not exceeding 3 hours. Exclusion criteria: The following patients will be excluded from the study: Patients for emergency surgeries Surgeries taking place after 1pm (to account for diurnal variation in cortisol levels) Patients having altered mental state, history of psychiatric disorder, history of drug abuse or those on chronic pain medication Patients who have come for a repeat surgery and have already been included once in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin<br> | Drug: Melatonin 6 MG<br>* melatonin will be administered orally preoperatively as premedication<br>|
| Active Comparator: Gabapentin<br> | Drug: Gabapentin<br>* melatonin will be administered orally preoperatively as premedication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preoperative anxiety | evaluate the difference in the preoperative anxiety score(Numerical Rating Scale ) before and after drug administration | 30 minutes after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory markers | o The serum cortisol and IL6 levels (biochemical markers of stress) intraoperatively and postoperatively | before and 30 minutes after drug administrartion | 
| Sedation score | Sedation score based on Observer Assessment of Alertness/Sedation Scale (OAA/S) before and after drug administration | before and 30 minutes after drug administrartion | 
| post operative analgesia | o Total fentanyl consumption 24 hours post-surgery | 24 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melatonin, gabapentin, preoperative anxiety