Oral Melatonin as Premedication During MAC for Patients U... | NCT03732963

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 5, 2018Actual

Primary Completion Date

Nov 5, 2018Actual

Completion Date

Nov 7, 2018Actual

First Submitted Date

Sep 4, 2018

First Submission Date that Met QC Criteria

Nov 6, 2018

First Posted Date

Nov 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2018

Last Update Posted Date

Nov 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo (Group P)	Drug	Group P: 20 patients will receive a placebo tablet preoperatively.	Placebo (Group P)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Vital Signs	Blood pressure (mmHg) .	24 hours Postoperative
Number of intraoperative patients movements.	Intraoperative patients movements

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed Abdalla Mohamed, M.D	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University		Cairo		11451	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not Now

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

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

Masking Info

Masking

Triple

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

Who Masked

ParticipantCare ProviderInvestigator

ID	Term
D014363	Tryptamines
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists