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

NCT04034771 | Completed Phase 3

• 1 other identifier: sedation in TBI
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

TBI (Traumatic Brain Injury)

Keywords

melatonin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• • Arterial blood pressure

  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

Study Arms (2)

propofol and melatonin

EXPERIMENTAL

propofol iv infusion and melatonin 10 mg tablet through a nasogastric tube, once at admission.

Drug: Melatonin 10 MG Oral Tablet; Drug: Propofol

propofol and placebo

ACTIVE COMPARATOR

propofol iv infusion and a placebo tablets through a nasogastric tube once at admission

Drug: Propofol; Drug: Placebo oral tablet

Interventions

Melatonin 10 MG Oral Tablet DRUG

Melatonin tablets

Also known as: circadian

propofol and melatonin

Propofol DRUG

propofol amp

Also known as: diprivan

propofol and melatonin; propofol and placebo

Placebo oral tablet DRUG

sugar pill manufactured to mimic melatonin tablets

Also known as: palacebo tabletes (for melatonin)

propofol and placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age group from 18 to 65
• Both sexes
• Patients on a mechanical ventilation and need sedation
• Patients who are vitally stable

You may not qualify if:

• Gastro intestinal tract impractabililty
• Pregnant female
• Vitally unstable patients who cannot tolerate propofol infusion

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alini Univeristy Hospital

Cairo, Giza Governorate, 11451, Egypt

Location

Related 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. doi: 10.1017/s0265021505000335.

  PMID: 15852991 BACKGROUND

• 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.

  PMID: 20823763 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Melatonin; Tablets; Propofol

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dosage Forms; Pharmaceutical Preparations; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Mahmoud s Soliman, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patient will be under general sedation
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 26, 2019
• Study Start: January 1, 2018
• Primary Completion: April 1, 2018
• Study Completion: April 5, 2018
• Last Updated: July 26, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: one month
• Access Criteria: open

Locations

EG (1)