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

Phase 3

Completed

• Conditions: TBI (Traumatic Brain Injury)
• Interventions: Drug: Melatonin 10 MG Oral Tablet; Drug: Propofol; Drug: Placebo oral tablet

• Registration Number: NCT04034771
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-04-01
• Study Completion: 2018-04-05
• Status Verified: 2019-07
• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-07-25
• Last Update Submitted: 2019-07-25
• Study First Posted: 2019-07-26
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol and melatonin	Melatonin 10 MG Oral Tablet	propofol iv infusion and melatonin 10 mg tablet through a nasogastric tube, once at admission.
propofol and melatonin	Propofol	propofol iv infusion and melatonin 10 mg tablet through a nasogastric tube, once at admission.
propofol and placebo	Propofol	propofol iv infusion and a placebo tablets through a nasogastric tube once at admission
propofol and placebo	Placebo oral tablet	propofol iv infusion and a placebo tablets through a nasogastric tube once at admission

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
• 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

Trial Locations

Locations (1)

Kasr Alini Univeristy Hospital; 🇪🇬 Cairo, Giza, Egypt