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

Cairo University (CU)

Status and phase: Completed; Phase 1

Conditions: Monitored Anaesthesia Care; Loco-regional Chronic Subdural Hematoma Evacuation

Treatments: Drug: Placebo (Group P); Drug: Melatonin (Group M)

Study type: Interventional

Funder types: Other

Identifiers

NCT03732963

N 45-2018/Ms

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Placebo (Group P)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (Group P)

Melatonin (Group M)

Active Comparator group

Description:

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

Treatment:

Drug: Melatonin (Group M)