NCT04034771

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• TBI (Traumatic Brain Injury)

Interventions

Type	Name	Description
DRUG	Melatonin 10 MG Oral Tablet	Melatonin tablets
DRUG	Propofol	propofol amp
DRUG	Placebo oral tablet	sugar pill manufactured to mimic melatonin tablets

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-04-01
• Completion: 2018-04-05
• First posted: 2019-07-26
• Last updated: 2019-07-26

Locations

1 site across 1 country: Egypt