Trials / Completed
CompletedNCT03732963
Oral Melatonin as Premedication During MAC for Patients Undergoing Loco-regional Chronic Subdural Hematoma Evacuation
Oral Melatonin as Premedication During Monitored Anaesthesia Care for Patients Undergoing Loco-regional Chronic Subdural Hematoma Evacuation, a Randomized Controlled Trial
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Cairo University · Academic / Other
- Sex
- All
- Age
- 50 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo (Group P) | Group P: 20 patients will receive a placebo tablet preoperatively. |
| DRUG | Melatonin (Group M) | Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively. |
Timeline
- Start date
- 2018-09-05
- Primary completion
- 2018-11-05
- Completion
- 2018-11-07
- First posted
- 2018-11-07
- Last updated
- 2018-11-27
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT03732963. Inclusion in this directory is not an endorsement.