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

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.

Study Overview

• Status: Completed
• Conditions: TBI (Traumatic Brain Injury)
• Intervention / Treatment: Drug: Melatonin 10 MG Oral Tablet; Drug: Propofol; Drug: Placebo oral tablet

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 11451
      • Kasr Alini Univeristy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: propofol and melatonin; propofol iv infusion and melatonin 10 mg tablet through a nasogastric tube, once at admission.	Drug: Melatonin 10 MG Oral Tablet; Melatonin tablets; Other Names: circadian; Drug: Propofol; propofol amp; Other Names: diprivan
Active Comparator: propofol and placebo; propofol iv infusion and a placebo tablets through a nasogastric tube once at admission	Drug: Propofol; propofol amp; Other Names: diprivan; Drug: Placebo oral tablet; sugar pill manufactured to mimic melatonin tablets; Other Names: palacebo tabletes (for melatonin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
• 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
Heart rate		Measuring the heart rate as beats per minutes just before and after propofol infusion and every hour for the next 6 hours

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mahmoud s Soliman, MD, Cairo University

Publications and helpful links

General Publications

• 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. doi: 10.1017/s0265021505000335.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 5, 2018

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 25, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: melatonin
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Protective Agents; Hypnotics and Sedatives; Antioxidants; Propofol; Melatonin
• Other Study ID Numbers: sedation in TBI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified participant data for primary and secondary outcome measures will be made available
• IPD Sharing Time Frame: one month
• IPD Sharing Access Criteria: open
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No