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

Phase 1

Completed

• Conditions: Loco-regional Chronic Subdural Hematoma Evacuation; Monitored Anaesthesia Care
• Interventions: Drug: Melatonin (Group M); Drug: Placebo (Group P)

• Registration Number: NCT03732963
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2018-09-04
• Study Start: 2018-09-05
• Status Verified: 2018-11
• Primary Completion: 2018-11-05
• Study First Submitted QC: 2018-11-06
• Study Completion: 2018-11-07
• Study First Posted: 2018-11-07
• Last Update Submitted: 2018-11-25
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin (Group M)	Melatonin (Group M)	Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively.
Placebo (Group P)	Placebo (Group P)	Group P: 20 patients will receive a placebo tablet preoperatively.

Primary Outcome Measures

Name	Time	Method
To compare propofol consumption among both groups.	24 hours Postoperative	propofol consumption per mg among both groups.

Secondary Outcome Measures

Name	Time	Method
Number of intraoperative patients movements.	24 hours Postoperative	Intraoperative patients movements
Time to first rescue analgesic in both groups.	24 hours Postoperative	Time to first rescue analgesic in both groups.
VAS score for pain in each group	24 hours Postoperative	VAS score for pain in each group
Vital Signs	24 hours Postoperative	Blood pressure (mmHg) .
Anesthesia recovery times /Hour in both groups.	24 hours Postoperative	Anesthesia recovery times in both groups

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt