Loco-regional Chronic Subdural Hematoma Evacuation, Monitored Anaesthesia Care
Conditions
Keywords
Oral Melatonin Premedication
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.
Interventions
DRUGPlacebo (Group P)
Group P: 20 patients will receive a placebo tablet preoperatively.
DRUGMelatonin (Group M)
Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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
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
Eligibility
Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare propofol consumption among both groups. | 24 hours Postoperative | propofol consumption per mg among both groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vital Signs | 24 hours Postoperative | Blood pressure (mmHg) . |
| Number of intraoperative patients movements. | 24 hours Postoperative | Intraoperative patients movements |
| Anesthesia recovery times /Hour in both groups. | 24 hours Postoperative | Anesthesia recovery times in both groups |
| VAS score for pain in each group | 24 hours Postoperative | VAS score for pain in each group |
| Time to first rescue analgesic in both groups. | 24 hours Postoperative | Time to first rescue analgesic in both groups. |
Countries
Egypt
Outcome results
None listed