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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-05

Study Completion Date

2018-11-07

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.

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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.

Conditions

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Monitored Anaesthesia Care Loco-regional Chronic Subdural Hematoma Evacuation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

(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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Randomization will be done via computer generated numbers and concealed by serially numbered, opaque and sealed envelopes. The details of series will be unknown to the investigators and the group assignment will be kept in a set of concealed envelopes each bearing only the case number on the outside. Prior to the start of the study, the appropriately numbered envelopes will be opened by the nurse, the card will determine the assigned intervention for each patient, which will be prepared by a clinical pharmacist with no other role in the study

Study Groups

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Placebo (Group P)

Group P: 20 patients will receive a placebo tablet preoperatively.

Group Type PLACEBO_COMPARATOR

Placebo (Group P)

Intervention Type DRUG

Group P: 20 patients will receive a placebo tablet preoperatively.

Melatonin (Group M)

Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively.

Group Type ACTIVE_COMPARATOR

Melatonin (Group M)

Intervention Type DRUG

Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively.

Interventions

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Placebo (Group P)

Group P: 20 patients will receive a placebo tablet preoperatively.

Intervention Type DRUG

Melatonin (Group M)

Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively.

Intervention Type DRUG

Other Intervention Names

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Placebo Group Melatonin Group

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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes