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NCT Number: NCT04034771

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

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.

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Key information

Conditions

TBI (Traumatic Brain Injury) Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kasr Alini Univeristy Hospital

Cairo, Giza Governorate, 11451, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin 10 MG Oral Tablet

Drug

Melatonin tablets

Other names: circadian

Propofol

Drug

propofol amp

Other names: diprivan

Placebo oral tablet

Drug

sugar pill manufactured to mimic melatonin tablets

Other names: palacebo tabletes (for melatonin)

Primary outcomes

  1. level of sedation

    Time frame: 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 outcomes

  1. • Arterial blood pressure

    Time frame: 6 hours

    measuring Blood pressure in mmgh just before and after start of propofol infusion and every hour for successive 6 hours

  2. Heart rate

    Time frame: Measuring the heart rate as beats per minutes just before and after propofol infusion and every hour for the next 6 hours

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 26, 2019
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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