TBI (Traumatic Brain Injury)Phase 3NCT04034771
The Effect of Melatonin Administration on Sedation Level as Adjuvant to Propofol
A Phase 3 study testing Melatonin 10 MG Oral Tablet and Propofol in people with TBI (Traumatic Brain Injury), run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- Melatonin 10 MG Oral Tablet and Propofol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 5 Apr 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age group from 18 to 65
- Both sexes
- Patients on a mechanical ventilation and need sedation
- Patients who are vitally stable
Who cannot join
- Gastro intestinal tract impractabililty
- Pregnant female
- Vitally unstable patients who cannot tolerate propofol infusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- TBI (Traumatic Brain Injury)
- Being tested
- Melatonin 10 MG Oral Tablet, Propofol, Placebo oral tablet
- Keywords
- melatonin
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 10 MG Oral TabletDrug
Also called circadian
Melatonin tablets
PropofolDrug
Also called diprivan
propofol amp
Placebo oral tabletDrug
Also called palacebo tabletes (for melatonin)
sugar pill manufactured to mimic melatonin tablets
| Study group | Role | What they receive |
|---|---|---|
| propofol and melatonin | Experimental | propofol iv infusion and melatonin 10 mg tablet through a nasogastric tube, once at admission. Receives: 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 Receives: Drug: Propofol; Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 hours
Secondary outcomes (2)
• Arterial blood pressure
measuring Blood pressure in mmgh just before and after start of propofol infusion and every hour for successive 6 hours
Measured: 6 hours
Heart rate
Measured: Measuring the heart rate as beats per minutes just before and after propofol infusion and every hour for the next 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Jan 2018
- Primary completion1 Apr 2018
- Study completion5 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mahmoud salem soliman, Cairo University
- Investigators
- Mahmoud s Soliman, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034771
- Sponsor's protocol ID
- sedation in TBI
- Status last verified
- Jul 2019
- First submitted
- 23 Jul 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data for primary and secondary outcome measures will be made available
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.
PubMed 15852991Yousaf 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.
PubMed 20823763
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Melatonin Administration on Sedation Level as Adjuvant to Propofol in Mechanically Ventilated Traumatic Brain Injury Patient: RCT
- ClinicalTrials.gov ID
- NCT04034771
- Acronym / sponsor ID
- sedation in TBI
- Conditions
- TBI (Traumatic Brain Injury)
- Keywords
- melatonin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol and melatonin | Experimental | Drug: Melatonin 10 MG Oral Tablet, Drug: Propofolpropofol iv infusion and melatonin 10 mg tablet through a nasogastric tube, once at admission. |
| propofol and placebo | Active comparator | Drug: Propofol, Drug: Placebo oral tabletpropofol iv infusion and a placebo tablets through a nasogastric tube once at admission |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age group from 18 to 65
- Both sexes
- Patients on a mechanical ventilation and need sedation
- Patients who are vitally stable
Key exclusion criteria (3 listed)
- Gastro intestinal tract impractabililty
- Pregnant female
- Vitally unstable patients who cannot tolerate propofol infusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 10 MG Oral TabletAlso: circadianMelatonin tablets | Drug | propofol and melatonin |
| PropofolAlso: diprivanpropofol amp | Drug | propofol and melatonin, propofol and placebo |
| Placebo oral tabletAlso: palacebo tabletes (for melatonin)sugar pill manufactured to mimic melatonin tablets | Drug | propofol and placebo |
Primary outcome
level of sedation
Time frame: 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
2 secondary outcomes
• Arterial blood pressure
Time frame: 6 hours
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Background: PubMed 15852991Samarkandi 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.
- Background: PubMed 20823763Yousaf 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.
- Individual participant dataSharing planned: Yes. De-identified participant data for primary and secondary outcome measures will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud s Soliman, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Melatonin 10 MG Oral Tablet and Propofol in people with TBI (Traumatic Brain Injury), run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of sedation (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04034771, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.