Delirium in Old AgePhase 2NCT05640934
Melatonin for Post Operative Delirium Prevention in Elderly Patients
A Phase 2 study testing Melatonin in people with Delirium in Old Age, run by Menoufia University at 1 site in Egypt.
Trial summary
The present study will evaluate the role of melatonin prophylaxis in delirium prevention in elderly patients undergoing colorectal procedures. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium in Old Age
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2022to 5 Jul 2023
- Phase
- Phase 2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- American Society of Anaesthesiologists (ASA) I to III physical status
- Elective colorectal procedures
Who cannot join
- Allergy to the research drugs,
- Patients who have vision or hearing impairment
- History of cerebral disorders
- Uncorrected acid-base, fluid, and electrolyte abnormalities
- History of central nervous system function affecting drugs.
- Chronic sedative-hypnotic administration at least one month prior to surgery
- Alcohol abuse
- Patients with recorded preoperative nursing delirium screening score ≥ 2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Melatonin on the Postoperative Delirium in Geriatric Patients After Colorectal Surgeries. A Randomised Placebo-controlled Trial
The present study will evaluate the role of melatonin prophylaxis in delirium prevention in elderly patients undergoing colorectal procedures.
Read the detailed description
This study is a prospective randomised double-blind placebo-controlled trial. Patients who meet the criteria for inclusion/exclusion will be evaluated. Melatonin tablets will be administered as a premedication to patients in the melatonin group. Patients in the control group will be given placebo tablets as a premedication. Fentanyl 1ug/kg and propofol 1-2 mg/kg will be used to induce anaesthesia. Atracurium 0.5 mg/kg will be used for the facilitation of endotracheal intubation. Isoflurane will be used to maintain anaesthesia and the depth of anaesthesia will be adjusted by a Bispectral index monitor. Postoperatively, the patients will be monitored for the development of delirium.
- Conditions
- Delirium in Old Age
- Being tested
- Melatonin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
The patients will be given 5 mg melatonin the night before surgery, 12 hours before the scheduled time of surgery, followed by another 5 mg melatonin two hours before surgery.
PlaceboDrug
The patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin group | Active comparator | The patients will be given 5 mg melatonin the night before surgery, 12 hours before the scheduled time of surgery, followed by another 5 mg melatonin two hours before surgery. Receives: Drug: Melatonin |
| Control group | Placebo comparator | The patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium occurrence
Nursing delirium - screening score. It scores five items,Each item is rated from 0 to 2 where 0, absent; 1, mild; 2, severe. A score ≥ 2 is considered to have delirium.
Measured: Perioperative.
Secondary outcomes (7)
Degree of Sedation
Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation
Measured: Perioperative.
Intensity of pain
Pain Assessment in Advanced Dementia Scale from 0 to 10 . score 1 to 3=mild pain; 4 to 6=moderate pain; 7-to 10=severe pain.
Measured: Perioperative
Mean arterial blood pressure
mmHg
Measured: Perioperative
Heart rate
beats/minute
Measured: Perioperative
Hypotension
Number of patients with hypotension
Measured: Perioperative
Hypoxia
Number of patients with hypoxia
Measured: Perioperative
Blood transfusion needs
Number of patients needed blood transfusion
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start10 Dec 2022
- Primary completion2 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in Old AgeStudies of the same condition, open and under way.
- More trials run by Menoufia 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abd-Elazeem Abd-Elhameed Elbakry, Menoufia University
- Investigators
- Abd-Elazeem A Elbakry, MD, Principal investigator, Menoufia UniversityHazem E Elsersy, MD, Principal investigator, Menoufia UniversityIslam M El-Desoky, MD, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640934
- Sponsor's protocol ID
- 11/2022 ANEST10
- Status last verified
- Jul 2023
- First submitted
- 29 Nov 2022
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Melatonin on the Postoperative Delirium in Geriatric Patients After Colorectal Surgeries. A Randomised Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05640934
- Acronym / sponsor ID
- 11/2022 ANEST10
- Conditions
- Delirium in Old Age
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- 2 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 7 Dec 2022 (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.
The present study will evaluate the role of melatonin prophylaxis in delirium prevention in elderly patients undergoing colorectal procedures.
Detailed description
This study is a prospective randomised double-blind placebo-controlled trial. Patients who meet the criteria for inclusion/exclusion will be evaluated. Melatonin tablets will be administered as a premedication to patients in the melatonin group. Patients in the control group will be given placebo tablets as a premedication. Fentanyl 1ug/kg and propofol 1-2 mg/kg will be used to induce anaesthesia. Atracurium 0.5 mg/kg will be used for the facilitation of endotracheal intubation. Isoflurane will be used to maintain anaesthesia and the depth of anaesthesia will be adjusted by a Bispectral index monitor. Postoperatively, the patients will be monitored for the development of delirium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin group | Active comparator | Drug: MelatoninThe patients will be given 5 mg melatonin the night before surgery, 12 hours before the scheduled time of surgery, followed by another 5 mg melatonin two hours before surgery. |
| Control group | Placebo comparator | Drug: PlaceboThe patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- American Society of Anaesthesiologists (ASA) I to III physical status
- Elective colorectal procedures
Key exclusion criteria (8 listed)
- Allergy to the research drugs,
- Patients who have vision or hearing impairment
- History of cerebral disorders
- Uncorrected acid-base, fluid, and electrolyte abnormalities
- History of central nervous system function affecting drugs.
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 |
|---|---|---|
| MelatoninThe patients will be given 5 mg melatonin the night before surgery, 12 hours before the scheduled time of surgery, followed by another 5 mg melatonin two hours before surgery. | Drug | Melatonin group |
| PlaceboThe patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group. | Drug | Control group |
Primary outcome
Incidence of delirium occurrence
Time frame: Perioperative.
Nursing delirium - screening score. It scores five items,Each item is rated from 0 to 2 where 0, absent; 1, mild; 2, severe. A score ≥ 2 is considered to have delirium.
7 secondary outcomes
Degree of Sedation
Time frame: Perioperative.
Intensity of pain
Time frame: Perioperative
Mean arterial blood pressure
Time frame: Perioperative
Heart rate
Time frame: Perioperative
Hypotension
Time frame: Perioperative
Hypoxia
Time frame: Perioperative
Blood transfusion needs
Time frame: Perioperative
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 17 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Abd-Elazeem A Elbakry, MD principal investigator
Menoufia University
Hazem E Elsersy, MD principal investigator
Menoufia University
Islam M El-Desoky, MD principal investigator
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin in people with Delirium in Old Age, run by Menoufia 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 2 inclusion and 8 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 17 Jul 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidence of delirium occurrence (time frame: Perioperative.). 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 Jul 2023.