The Effect of Melatonin Administration on Sedation Level as Adjuvant to Propofol

The Effect of Melatonin Administration on Sedation Level as Adjuvant to Propofol in Mechanically Ventilated Traumatic Brain Injury Patient: RCT

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04034771

Enrollment

Registered

2019-07-26

Start date

2018-01-01

Completion date

2018-04-05

Last updated

2019-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TBI (Traumatic Brain Injury)

Keywords

melatonin

Brief summary

This study assess the effect of administration of exogenous melatonin as adjuvant to propofol on the level of sedation and consequently the rate of propofol infusion.

Detailed description

38 patients with traumatic brain injuries requiring mechanical ventilation and sedation were randomly allocated to two groups (melatonin group)19 patients and (control group)19 patients. In both groups a bolus of propofol 1mglkg was given by titration till the patient reached a sedation level value of (60-70) on the bispectral index (BIS), Then propofol infusion started at a rate of 1mglkglhr as a maintenance and rate adjusted according to our targeted sedation level, melatonin 10 mg tablet was crushed and mixed with 20 ml of water and administrated through a nasogastric tube followed by another 20 ml to flush out the residue for (melatonin group). While (control Group) received a placebo tablets by the same wayBIS value and propofol infusion rate was recorded over 12 hours.

Interventions

DRUGMelatonin 10 MG Oral Tablet

Melatonin tablets

DRUGPropofol

propofol amp

DRUGPlacebo oral tablet

sugar pill manufactured to mimic melatonin tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Masking description

patient will be under general sedation

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Age group from 18 to 65 * Both sexes * Patients on a mechanical ventilation and need sedation * Patients who are vitally stable

Exclusion criteria

* Gastro intestinal tract impractabililty * Pregnant female * Vitally unstable patients who cannot tolerate propofol infusion

Design outcomes

Primary

Measure	Time frame	Description
level of sedation	6 hours	observe the effect of the oral administration of 10 mg melatonin on decreasing the dose of propofol infusion in a mechanically ventilated patient with a traumatic brain injury using bispectral index

Secondary

Measure	Time frame	Description
• Arterial blood pressure	6 hours	measuring Blood pressure in mmgh just before and after start of propofol infusion and every hour for successive 6 hours
Heart rate	Measuring the heart rate as beats per minutes just before and after propofol infusion and every hour for the next 6 hours	—

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026