Monitored Anaesthesia CarePhase 1NCT03732963
Oral Melatonin as Premedication During MAC for Patients Undergoing Loco-regional Chronic Subdural Hematoma Evacuation
A Phase 1 study testing Melatonin (Group M) in people with Monitored Anaesthesia Care and Loco-regional Chronic Subdural Hematoma Evacuation, run by Cairo University at 1 site in Egypt.
Trial summary
investigators assume that administration of preoperative melatonin will reduce the required dose of propofol in participants undergoing loco-regional chronic subdural hematoma evacuation, it may as well provide better postoperative analgesia and decrease the incidence of delirium. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Monitored Anaesthesia Care, Loco-regional Chronic Subdural Hematoma Evacuation
- What is being tested?
- Melatonin (Group M)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Sep 2018to 7 Nov 2018
- Phase
- Phase 1
- 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 -65 years
- ASA grade I to II
- Both sexes
- Patients with unilateral chronic subdural hematoma
- Patients who are vitally stable
- Glascow coma scale 14-15
Who cannot join
- Age below 50 and above 65 years.
- Gastro intestinal tract impractabililty.
- Patients with any substance abuse.
- Patients with hepatic or renal insufficiency.
- Patients on antipsychotic, anticonvulsant or anti-parkinsonian medication.
- Vitally unstable patients who cannot tolerate propofol sedation.
- Patients with known allergies to any of the drugs used.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Melatonin as Premedication During Monitored Anaesthesia Care for Patients Undergoing Loco-regional Chronic Subdural Hematoma Evacuation, a Randomized Controlled Trial
investigators assume that administration of preoperative melatonin will reduce the required dose of propofol in participants undergoing loco-regional chronic subdural hematoma evacuation, it may as well provide better postoperative analgesia and decrease the incidence of delirium.
Read the detailed description
A number of studies showed that premedication with melatonin was associated with sedation without impairment of cognitive and psychomotor skills or prolonging recovery. Some studies demonstrated that melatonin decreases the amount of propofol required to produce an adequate depth of hypnosis at induction time
The effects of the oral administration of melatonin on the dose of propofol sedation in participants undergoing loco-regional chronic subdural hematoma evacuation have not been documented before.
The present study will be conducted to detect the efficacy of oral administration of melatonin on the reduction of the sedative dose of propofol in participants undergoing loco-regional chronic subdural hematoma evacuation.
- Being tested
- Placebo (Group P), Melatonin (Group M)
- Keywords
- Oral Melatonin Premedication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (Group P)Drug
Also called Placebo Group
Group P: 20 patients will receive a placebo tablet preoperatively.
Melatonin (Group M)Drug
Also called Melatonin Group
Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Placebo (Group P) | Placebo comparator | Group P: 20 patients will receive a placebo tablet preoperatively. Receives: Drug: Placebo (Group P) |
| Melatonin (Group M) | Active comparator | Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively. Receives: Drug: Melatonin (Group M) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare propofol consumption among both groups.
propofol consumption per mg among both groups.
Measured: 24 hours Postoperative
Secondary outcomes (5)
Vital Signs
Blood pressure (mmHg) .
Measured: 24 hours Postoperative
Number of intraoperative patients movements.
Intraoperative patients movements
Measured: 24 hours Postoperative
Anesthesia recovery times /Hour in both groups.
Anesthesia recovery times in both groups
Measured: 24 hours Postoperative
VAS score for pain in each group
VAS score for pain in each group
Measured: 24 hours Postoperative
Time to first rescue analgesic in both groups.
Time to first rescue analgesic in both groups.
Measured: 24 hours Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start5 Sep 2018
- Primary completion5 Nov 2018
- Study completion7 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monitored Anaesthesia CareStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- (N-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland. It is primarily responsible for the sleep awake cycle as its level decreases in the morning and increases by night; owing to reduced light intensity, leading to circadian rhythm. It provides circadian and seasonal timing through activation of G protein-coupled receptors (GPCRs) in target tissues. Melatonin exerts its hypnotic effects through the activation of the MT1 and MT2 melatonin receptors
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
- Investigators
- Ahmed Abdalla Mohamed, M.D, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732963
- Sponsor's protocol ID
- N 45-2018/Ms
- Status last verified
- Nov 2018
- First submitted
- 4 Sep 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not Now
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Melatonin as Premedication During Monitored Anaesthesia Care for Patients Undergoing Loco-regional Chronic Subdural Hematoma Evacuation, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03732963
- Acronym / sponsor ID
- N 45-2018/Ms
- Keywords
- Oral Melatonin Premedication
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 7 Nov 2018 (actual)
- First posted
- 7 Nov 2018 (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.
investigators assume that administration of preoperative melatonin will reduce the required dose of propofol in participants undergoing loco-regional chronic subdural hematoma evacuation, it may as well provide better postoperative analgesia and decrease the incidence of delirium.
Detailed description
A number of studies showed that premedication with melatonin was associated with sedation without impairment of cognitive and psychomotor skills or prolonging recovery. Some studies demonstrated that melatonin decreases the amount of propofol required to produce an adequate depth of hypnosis at induction time
The effects of the oral administration of melatonin on the dose of propofol sedation in participants undergoing loco-regional chronic subdural hematoma evacuation have not been documented before.
The present study will be conducted to detect the efficacy of oral administration of melatonin on the reduction of the sedative dose of propofol in participants undergoing loco-regional chronic subdural hematoma evacuation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- (N-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland. It is primarily responsible for the sleep awake cycle as its level decreases in the morning and increases by night; owing to reduced light intensity, leading to circadian rhythm. It provides circadian and seasonal timing through activation of G protein-coupled receptors (GPCRs) in target tissues. Melatonin exerts its hypnotic effects through the activation of the MT1 and MT2 melatonin receptors
| Arm | Type | Receives |
|---|---|---|
| Placebo (Group P) | Placebo comparator | Drug: Placebo (Group P)Group P: 20 patients will receive a placebo tablet preoperatively. |
| Melatonin (Group M) | Active comparator | Drug: Melatonin (Group M)Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 50 -65 years
- ASA grade I to II
- Both sexes
- Patients with unilateral chronic subdural hematoma
- Patients who are vitally stable
Key exclusion criteria (7 listed)
- Age below 50 and above 65 years.
- Gastro intestinal tract impractabililty.
- Patients with any substance abuse.
- Patients with hepatic or renal insufficiency.
- Patients on antipsychotic, anticonvulsant or anti-parkinsonian medication.
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 |
|---|---|---|
| Placebo (Group P)Also: Placebo GroupGroup P: 20 patients will receive a placebo tablet preoperatively. | Drug | Placebo (Group P) |
| Melatonin (Group M)Also: Melatonin GroupGroup M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively. | Drug | Melatonin (Group M) |
Primary outcome
To compare propofol consumption among both groups.
Time frame: 24 hours Postoperative
propofol consumption per mg among both groups.
5 secondary outcomes
Vital Signs
Time frame: 24 hours Postoperative
Number of intraoperative patients movements.
Time frame: 24 hours Postoperative
Anesthesia recovery times /Hour in both groups.
Time frame: 24 hours Postoperative
VAS score for pain in each group
Time frame: 24 hours Postoperative
Time to first rescue analgesic in both groups.
Time frame: 24 hours Postoperative
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 27 Nov 2018.
- Individual participant dataSharing planned: Undecided. Not Now
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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.
Ahmed Abdalla Mohamed, M.D 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 1 study testing Melatonin (Group M) in people with Monitored Anaesthesia Care and Loco-regional Chronic Subdural Hematoma Evacuation, 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 6 inclusion and 7 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 27 Nov 2018. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To compare propofol consumption among both groups. (time frame: 24 hours Postoperative). 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 27 Nov 2018.