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

Primary Purpose

TBI (Traumatic Brain Injury)

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Melatonin 10 MG Oral Tablet

Propofol

Placebo oral tablet

About this trial

This is an interventional supportive care trial for TBI (Traumatic Brain Injury) focused on measuring melatonin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kasr Alini Univeristy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

propofol and melatonin

propofol and placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

• Arterial blood pressure

measuring Blood pressure in mmgh just before and after start of propofol infusion and every hour for successive 6 hours

Heart rate

Full Information

NCT ID

NCT04034771

First Posted

July 23, 2019

Last Updated

July 25, 2019

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04034771

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

April 1, 2018 (Actual)

Study Completion Date

April 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

TBI (Traumatic Brain Injury)

Keywords

melatonin

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Masking Description

patient will be under general sedation

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

propofol and melatonin

Arm Type

Experimental

Arm Description

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

Arm Title

propofol and placebo

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Melatonin 10 MG Oral Tablet

Other Intervention Name(s)

circadian

Intervention Description

Melatonin tablets

Intervention Type

Drug

Intervention Name(s)

Propofol

Other Intervention Name(s)

diprivan

Intervention Description

propofol amp

Intervention Type

Drug

Intervention Name(s)

Placebo oral tablet

Other Intervention Name(s)

palacebo tabletes (for melatonin)

Intervention Description

sugar pill manufactured to mimic melatonin tablets

Primary Outcome Measure Information:

Title

level of sedation

Description

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

Time Frame

6 hours

Secondary Outcome Measure Information:

Title

• Arterial blood pressure

Description

measuring Blood pressure in mmgh just before and after start of propofol infusion and every hour for successive 6 hours

Time Frame

6 hours

Title

Heart rate

Time Frame

Measuring the heart rate as beats per minutes just before and after propofol infusion and every hour for the next 6 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mahmoud s Soliman, MD

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kasr Alini Univeristy Hospital

City

Cairo

State/Province

Giza

ZIP/Postal Code

11451

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

15852991

Citation

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.

Results Reference

background

PubMed Identifier

20823763

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.

Results Reference

background

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

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