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

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.

Study Overview

• Status: Completed
• Conditions: Monitored Anaesthesia Care; Loco-regional Chronic Subdural Hematoma Evacuation
• Intervention / Treatment: Drug: Placebo (Group P); Drug: Melatonin (Group M)

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo (Group P); Group P: 20 patients will receive a placebo tablet preoperatively.	Drug: Placebo (Group P); Group P: 20 patients will receive a placebo tablet preoperatively.; Other Names: Placebo Group
Active Comparator: Melatonin (Group M); Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively.	Drug: Melatonin (Group M); Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively.; Other Names: Melatonin Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare propofol consumption among both groups.	propofol consumption per mg among both groups.	24 hours Postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2018
• Primary Completion (Actual): November 5, 2018
• Study Completion (Actual): November 7, 2018

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 25, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Oral Melatonin Premedication
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: N 45-2018/Ms

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Not Now

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No