DexmedetomidineNCT06076668
Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium
A study testing Dexmedetomidine, Melatonin 3 MG and Saline in people with Dexmedetomidine and Melatonin, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare the effect of dexmedetomidine infusion and oral melatonin on preventing delirium in intensive care unit (ICU) patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dexmedetomidine, Melatonin, Delirium
- What is being tested?
- Dexmedetomidine, Melatonin 3 MG and Saline
- 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
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Oct 2023to 20 Oct 2024
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 21 years or older.
- Either gender.
- Healthy gastrointestinal function (patients tolerated oral medications by gavage or mouth).
- Richmond Agitation Sedation Scale (RASS) >-1.
- No basic delirium or mood changes before admission to intensive care unit(ICU).
Who cannot join
- Patient refusal.
- History of irreversible brain disease consistent with severe dementia.
- Patient admitted with a primary neurologic condition or injury (e.g., intracranial hemorrhage).
- Heart rate (HR) less than 50 beats/ min or second- third degree heart block in the absence of a pacemaker.
- Acute alcohol withdrawal requiring benzodiazepine administration.
- History of hepatic encephalopathy or end-stage liver disease (Child-Pugh class B or C).
Show all 10Show fewer
- The expected duration of intensive care unit (ICU) stay less than 5 days.
- Inability to obtain informed consent.
- Pregnancy.
- Allergy to dexmedetomidine or melatonin.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Eslam M Salem, Msc, 00201004415074, salemeslam913@gmail.com
Ayman A Youssef, MD
About this study
Official title: Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Unit (ICU) Delirium; A Prospective Randomized Controlled Study
This study aims to compare the effect of dexmedetomidine infusion and oral melatonin on preventing delirium in intensive care unit (ICU) patients.
Read the detailed description
Delirium is experienced in 20% to 40% of the critically ill and up to 80% of mechanically ventilated (MV) medical or surgical patients . It is a confessional state that has been described as a transient global disorder of cognition, awareness, and attention and as such is not only challenging for the treating medical team, but also has a considerable impact on affected patients. It is associated with prolonged hospital length of stay and time on MV, deterioration in cognition, and increased morbidity and mortality causing additional health-care expenses.
- Conditions
- Dexmedetomidine, Melatonin, Delirium
- Being tested
- Dexmedetomidine, Melatonin 3 MG, Saline
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called DEX group
Patients will receive an intravenous dexmedetomidine infusion of 0.2 mcg/kg/h starting at 9 p.m. The infusion will be halved at 6:00 A.M. and discontinued at 6:15 A.M.
Melatonin 3 MGDrug
Also called N-acetyl-5-methoxytryptamine
Patients will receive oral melatonin tablet 3 mg 9:00 p.m.
SalineDrug
Also called Control group
Patients will receive saline infusion at the same rate of dexmedetomidine infusion and placebo capsule similar to that of melatonin.
| Study group | Role | What they receive |
|---|---|---|
| Group D (n=30) | Experimental | patients will receive intravenous dexmedetomidine infusion of 0.2 mcg/kg/h starting at 9 p.m. The infusion will be halved at 6:00 A.M. and discontinued at 6:15 A.M. Receives: Drug: Dexmedetomidine |
| Group M (n=30) | Experimental | patients will receive oral melatonin tablet 3 mg at 9:00 p.m. Receives: Drug: Melatonin 3 MG |
| Control group | Placebo comparator | patients will receive saline infusion at the same rate of dexmedetomidine infusion and placebo capsule similar to that of melatonin. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of delirium
The incidence of delirium within 14 days from admission to the intensive care unit (ICU) or until ICU discharge before this time. Every 12 hours throughout the study.
Measured: 14 days from admission to intensive care unit
Secondary outcomes (4)
The onset of delirium. • Duration of delirium. • Frequency of delirium. • Length of ICU stay. • Total dose of Haloperidol per day.
Delirium was assessed using Confusion Assessment Method for intensive care unit (CAM- ICU) score at admission to ICU and every 12hr throughout the study.
The final CAM-ICU score ranges from 0-7 with 7 being most severe. CAM-ICU-7 scores were further categorized as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium.
Measured: 14 days from admission to intensive care unit
Duration of delirium
Delirium was assessed using Confusion Assessment Method for intensive care unit(CAM- ICU) score at admission to ICU and every 12hr throughout the study.
The final CAM-ICU score ranges from 0-7 with 7 being most severe. CAM-ICU-7 scores were further categorized as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium.
Measured: 14 days from admission to intensive care unit
Frequency of delirium
Delirium was assessed using Confusion Assessment Method for intensive care unit(CAM- ICU)score at admission to ICU and every 12hr throughout the study.
The final CAM-ICU score ranges from 0-7 with 7 being most severe. CAM-ICU-7 scores were further categorized as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium.
Measured: 14 days from admission to intensive care unit
Total dose of Haloperidol per day
Total dose of Haloperidol per day 14 days from admission to intensive care unit
Measured: 14 days from admission to intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start16 Oct 2023
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, eslam salem, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076668
- Sponsor's protocol ID
- Dexmedetomidine
- Status last verified
- Oct 2023
- First submitted
- 16 Sep 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Unit (ICU) Delirium; A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06076668
- Acronym / sponsor ID
- Dexmedetomidine
- Conditions
- Dexmedetomidine, Melatonin, Delirium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 11 Oct 2023 (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 aims to compare the effect of dexmedetomidine infusion and oral melatonin on preventing delirium in intensive care unit (ICU) patients.
Detailed description
Delirium is experienced in 20% to 40% of the critically ill and up to 80% of mechanically ventilated (MV) medical or surgical patients . It is a confessional state that has been described as a transient global disorder of cognition, awareness, and attention and as such is not only challenging for the treating medical team, but also has a considerable impact on affected patients. It is associated with prolonged hospital length of stay and time on MV, deterioration in cognition, and increased morbidity and mortality causing additional health-care expenses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group D (n=30) | Experimental | Drug: Dexmedetomidinepatients will receive intravenous dexmedetomidine infusion of 0.2 mcg/kg/h starting at 9 p.m. The infusion will be halved at 6:00 A.M. and discontinued at 6:15 A.M. |
| Group M (n=30) | Experimental | Drug: Melatonin 3 MGpatients will receive oral melatonin tablet 3 mg at 9:00 p.m. |
| Control group | Placebo comparator | Drug: Salinepatients will receive saline infusion at the same rate of dexmedetomidine infusion and placebo capsule similar to that of melatonin. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 21 years or older.
- Either gender.
- Healthy gastrointestinal function (patients tolerated oral medications by gavage or mouth).
- Richmond Agitation Sedation Scale (RASS) >-1.
- No basic delirium or mood changes before admission to intensive care unit(ICU).
Key exclusion criteria (10 listed)
- Patient refusal.
- History of irreversible brain disease consistent with severe dementia.
- Patient admitted with a primary neurologic condition or injury (e.g., intracranial hemorrhage).
- Heart rate (HR) less than 50 beats/ min or second- third degree heart block in the absence of a pacemaker.
- Acute alcohol withdrawal requiring benzodiazepine administration.
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 |
|---|---|---|
| DexmedetomidineAlso: DEX groupPatients will receive an intravenous dexmedetomidine infusion of 0.2 mcg/kg/h starting at 9 p.m. The infusion will be halved at 6:00 A.M. and discontinued at 6:15 A.M. | Drug | Group D (n=30) |
| Melatonin 3 MGAlso: N-acetyl-5-methoxytryptaminePatients will receive oral melatonin tablet 3 mg 9:00 p.m. | Drug | Group M (n=30) |
| SalineAlso: Control groupPatients will receive saline infusion at the same rate of dexmedetomidine infusion and placebo capsule similar to that of melatonin. | Drug | Control group |
Primary outcome
The incidence of delirium
Time frame: 14 days from admission to intensive care unit
The incidence of delirium within 14 days from admission to the intensive care unit (ICU) or until ICU discharge before this time. Every 12 hours throughout the study.
4 secondary outcomes
The onset of delirium. • Duration of delirium. • Frequency of delirium. • Length of ICU stay. • Total dose of Haloperidol per day.
Time frame: 14 days from admission to intensive care unit
Duration of delirium
Time frame: 14 days from admission to intensive care unit
Frequency of delirium
Time frame: 14 days from admission to intensive care unit
Total dose of Haloperidol per day
Time frame: 14 days from admission to intensive care unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, Melatonin 3 MG and Saline in people with Dexmedetomidine and Melatonin, run by Tanta 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 17 Oct 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eslam Eslam, MD (01004415074, salemeslam913@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of delirium (time frame: 14 days from admission to intensive care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2023.