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

TBI (Traumatic Brain Injury) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04034771
• Other study ID #: sedation in TBI
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2018
• Est. completion date: April 5, 2018

Study information

• Verified date: July 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 5, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• TBI (Traumatic Brain Injury)

Intervention

Drug:
• Melatonin 10 MG Oral Tablet
Melatonin tablets
• Propofol
propofol amp
• Placebo oral tablet
sugar pill manufactured to mimic melatonin tablets

Locations

Country	Name	City	State
Egypt	Kasr Alini Univeristy Hospital	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Samarkandi A, Naguib M, Riad W, Thalaj A, Alotibi W, Aldammas F, Albassam A. Melatonin vs. midazolam premedication in children: a double-blind, placebo-controlled study. Eur J Anaesthesiol. 2005 Mar;22(3):189-96. — View Citation

Yousaf F, Seet E, Venkatraghavan L, Abrishami A, Chung F. Efficacy and safety of melatonin as an anxiolytic and analgesic in the perioperative period: a qualitative systematic review of randomized trials. Anesthesiology. 2010 Oct;113(4):968-76. doi: 10.1097/ALN.0b013e3181e7d626. Review. — View Citation

Outcome

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