Clinical trial NCT03732963: Oral Melatonin as Premedication During MAC for Patients Undergoing Loco-regional Chronic Subdural Hematoma Evacuation
Official title: Oral Melatonin as Premedication During Monitored Anaesthesia Care for Patients Undergoing Loco-regional Chronic Subdural Hematoma Evacuation, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Monitored Anaesthesia Care
Loco-regional Chronic Subdural Hematoma Evacuation
Keywords: Oral Melatonin Premedication
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To compare propofol consumption among both groups.
timeFrame: 24 hours Postoperative
Secondary outcomes:
measure: Vital Signs
timeFrame: 24 hours Postoperative
measure: Number of intraoperative patients movements.
timeFrame: 24 hours Postoperative
measure: Anesthesia recovery times /Hour in both groups.
timeFrame: 24 hours Postoperative
measure: VAS score for pain in each group
timeFrame: 24 hours Postoperative
measure: Time to first rescue analgesic in both groups.
timeFrame: 24 hours Postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Ahmed Abdalla Mohamed, M.D
role: PRINCIPAL_INVESTIGATOR
References: