The Effect of Melatonin Administration on Sedation Level as Adjuvant to Propofol

Study Overview
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Brief Summary
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This study assess the effect of administration of exogenous melatonin as adjuvant to propofol on the level of sedation and consequently the rate of propofol infusion.

Detailed Description
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38 patients with traumatic brain injuries requiring mechanical ventilation and sedation were randomly allocated to two groups (melatonin group)19 patients and (control group)19 patients. In both groups a bolus of propofol 1mglkg was given by titration till the patient reached a sedation level value of (60-70) on the bispectral index (BIS), Then propofol infusion started at a rate of 1mglkglhr as a maintenance and rate adjusted according to our targeted sedation level, melatonin 10 mg tablet was crushed and mixed with 20 ml of water and administrated through a nasogastric tube followed by another 20 ml to flush out the residue for (melatonin group). While (control Group) received a placebo tablets by the same wayBIS value and propofol infusion rate was recorded over 12 hours.

Official Title
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The Effect of Melatonin Administration on Sedation Level as Adjuvant to Propofol in Mechanically Ventilated Traumatic Brain Injury Patient: RCT

Conditions
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TBI (Traumatic Brain Injury)

Intervention / Treatment
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* Drug: Melatonin 10 MG Oral Tablet
* Drug: Propofol
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age group from 18 to 65 Both sexes Patients on a mechanical ventilation and need sedation Patients who are vitally stable Exclusion Criteria: Gastro intestinal tract impractabililty Pregnant female Vitally unstable patients who cannot tolerate propofol infusion

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: propofol and melatonin<br>propofol iv infusion and melatonin 10 mg tablet through a nasogastric tube, once at admission. | Drug: Melatonin 10 MG Oral Tablet<br>* Melatonin tablets<br>* Other names: circadian;Drug: Propofol<br>* propofol amp<br>* Other names: diprivan;|
| Active Comparator: propofol and placebo<br>propofol iv infusion and a placebo tablets through a nasogastric tube once at admission | Drug: Propofol<br>* propofol amp<br>* Other names: diprivan;Drug: Placebo oral tablet<br>* sugar pill manufactured to mimic melatonin tablets<br>* Other names: palacebo tabletes (for melatonin);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of sedation | observe the effect of the oral administration of 10 mg melatonin on decreasing the dose of propofol infusion in a mechanically ventilated patient with a traumatic brain injury using bispectral index | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Arterial blood pressure | measuring Blood pressure in mmgh just before and after start of propofol infusion and every hour for successive 6 hours | 6 hours | 
| Heart rate |  | Measuring the heart rate as beats per minutes just before and after propofol infusion and every hour for the next 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melatonin