Oral Melatonin as Premedication During MAC for Patients Undergoing Loco-regional Chronic Subdural Hematoma Evacuation

Study Overview
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Brief Summary
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investigators assume that administration of preoperative melatonin will reduce the required dose of propofol in participants undergoing loco-regional chronic subdural hematoma evacuation, it may as well provide better postoperative analgesia and decrease the incidence of delirium.

Detailed Description
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A number of studies showed that premedication with melatonin was associated with sedation without impairment of cognitive and psychomotor skills or prolonging recovery. Some studies demonstrated that melatonin decreases the amount of propofol required to produce an adequate depth of hypnosis at induction time The effects of the oral administration of melatonin on the dose of propofol sedation in participants undergoing loco-regional chronic subdural hematoma evacuation have not been documented before. The present study will be conducted to detect the efficacy of oral administration of melatonin on the reduction of the sedative dose of propofol in participants undergoing loco-regional chronic subdural hematoma evacuation.

Official Title
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Oral Melatonin as Premedication During Monitored Anaesthesia Care for Patients Undergoing Loco-regional Chronic Subdural Hematoma Evacuation, a Randomized Controlled Trial

Conditions
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Monitored Anaesthesia Care, Loco-regional Chronic Subdural Hematoma Evacuation

Intervention / Treatment
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* Drug: Placebo (Group P)
* Drug: Melatonin (Group M)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 -65 years ASA grade I to II Both sexes Patients with unilateral chronic subdural hematoma Patients who are vitally stable Glascow coma scale 14-15 Exclusion Criteria: Age below 50 and above 65 years. Gastro intestinal tract impractabililty. Patients with any substance abuse. Patients with hepatic or renal insufficiency. Patients on antipsychotic, anticonvulsant or anti-parkinsonian medication. Vitally unstable patients who cannot tolerate propofol sedation. Patients with known allergies to any of the drugs used.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: (N-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland. It is primarily responsible for the sleep awake cycle as its level decreases in the morning and increases by night; owing to reduced light intensity, leading to circadian rhythm. It provides circadian and seasonal timing through activation of G protein-coupled receptors (GPCRs) in target tissues. Melatonin exerts its hypnotic effects through the activation of the MT1 and MT2 melatonin receptors
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo (Group P)<br>Group P: 20 patients will receive a placebo tablet preoperatively. | Drug: Placebo (Group P)<br>* Group P: 20 patients will receive a placebo tablet preoperatively.<br>* Other names: Placebo Group;|
| Active Comparator: Melatonin (Group M)<br>Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively. | Drug: Melatonin (Group M)<br>* Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively.<br>* Other names: Melatonin Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare propofol consumption among both groups. | propofol consumption per mg among both groups. | 24 hours Postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital Signs | Blood pressure (mmHg) . | 24 hours Postoperative | 
| Number of intraoperative patients movements. | Intraoperative patients movements | 24 hours Postoperative | 
| Anesthesia recovery times /Hour in both groups. | Anesthesia recovery times in both groups | 24 hours Postoperative | 
| VAS score for pain in each group | VAS score for pain in each group | 24 hours Postoperative | 
| Time to first rescue analgesic in both groups. | Time to first rescue analgesic in both groups. | 24 hours Postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Melatonin Premedication