Delirium, Anesthesia EmergenceNCT05236907
The Efficacy of Oral Melatonin in Preventing Postoperative Delirium for Patients Undergoing Orthopedic Surgery Under General Anesthesia
A study testing Melatonin and Midazolam in people with Delirium, Anesthesia Emergence and Delirium, run by University of Baghdad at 2 sites in Iraq.
Trial summary
Postoperative delirium is a complication that should not be underestimated. As it elaborates many complications that could be avoided when an accurate assessment of the risk factors and interventional measures are taken appropriately when needed. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium, Anesthesia Emergence, Delirium
- What is being tested?
- Melatonin and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesIraq
- Study dates
- 1 Jul 2020to 1 Nov 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1- Patients in good general health. 2. Baseline MDAS <13. 3. No seizure disorder.
Who cannot join
- Patients with a neurological disorder (e.g., dementia, stroke, epilepsy).
- Patients with a history of acute or chronic confusion.
- Patients taking centrally acting drugs (e.g., antidepressants, antiparkinsonian drugs, sedatives, monoamine oxidase inhibitors), or alcohol abusers.
- Patients who have medical disorders predisposing to delirium (e.g. cachexia, thyroid dysfunction, renal failure).
Trial locations and contacts
2 sites in 1 country.
Iraq2 sites
Al-Kadhemya Private Hospital
Baghdad, 10047
Ghazi Al-Hariri Teaching Hospital
Baghdad, 10047
About this study
Postoperative delirium is a complication that should not be underestimated. As it elaborates many complications that could be avoided when an accurate assessment of the risk factors and interventional measures are taken appropriately when needed.
Read the detailed description
Delirium is a variation in concentration capabilities that occurs acutely in association with a disturbed level of consciousness. Delirium is more common in orthopaedic surgery patients than in general surgery patients. As delirium ratios range from 44% to 55% in hip surgery patients, otherwise only 10%-14% of general surgery patients. Several studies were carried out and found that melatonin levels correlate with the development of delirium postoperatively. This study was conducted to determine the efficacy of administering melatonin preoperatively in patients undergoing orthopedic surgery to prevent postoperative delirium.
- Conditions
- Delirium, Anesthesia Emergence, Delirium
- Keywords
- Delirium, melatonin, patients, surgery, postoperative, benzodiazepines, orthopedic, preoperatively
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Also called Midazolam
The patients were assessed using the Memorial Delirium Assessment Scale (MDAS) after the operation at 30, 60, and 90 min. Melatonin was shown to reduce delirium from 41.6% to 16.6% at 60 minutes, and the significant reduction was at 90 minutes (0%) when compared to both groups. Thus, melatonin was found to be successful in decreasing postoperative delirium when administered preoperatively.
No interventionOther
No intervention was used.
MidazolamDrug
7.5 mg of Midazolam orally.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Patients in this group received nothing for sedation. Receives: Other: No intervention |
| Midazolam group | Active comparator | 7.5 mg of Midazolam were given orally the night before operation. Another dose 90 min. preoperatively. Receives: Drug: Midazolam |
| Melatonin group | Experimental | 5 mg of Melatonin were given orally the night before operation. Another dose 90 min. preoperatively Receives: Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of oral Melatonin in preventing Postoperative Delirium after general anesthesia
This interventional trial is done to determine the efficacy of preoperative melatonin administration in reducing postoperative delirium rates.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Jul 2020
- Primary completion30 Oct 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium, Anesthesia EmergenceStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Model description
- Patients were divided into three groups at random, with 12 patients in each group, using a double-blinded method.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hashim Talib Hashim, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236907
- Sponsor's protocol ID
- Melatonin123
- Status last verified
- Feb 2022
- First submitted
- 6 Jan 2022
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Oral Melatonin in Preventing Postoperative Delirium for Patients Undergoing Orthopedic Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT05236907
- Acronym / sponsor ID
- Melatonin123
- Conditions
- Delirium, Anesthesia Emergence, Delirium
- Keywords
- Delirium, melatonin, patients, surgery, postoperative, benzodiazepines, orthopedic, preoperatively
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 11 Feb 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.
Postoperative delirium is a complication that should not be underestimated. As it elaborates many complications that could be avoided when an accurate assessment of the risk factors and interventional measures are taken appropriately when needed.
Detailed description
Delirium is a variation in concentration capabilities that occurs acutely in association with a disturbed level of consciousness. Delirium is more common in orthopaedic surgery patients than in general surgery patients. As delirium ratios range from 44% to 55% in hip surgery patients, otherwise only 10%-14% of general surgery patients. Several studies were carried out and found that melatonin levels correlate with the development of delirium postoperatively. This study was conducted to determine the efficacy of administering melatonin preoperatively in patients undergoing orthopedic surgery to prevent postoperative delirium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients were divided into three groups at random, with 12 patients in each group, using a double-blinded method.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: No interventionPatients in this group received nothing for sedation. |
| Midazolam group | Active comparator | Drug: Midazolam7.5 mg of Midazolam were given orally the night before operation. Another dose 90 min. preoperatively. |
| Melatonin group | Experimental | Drug: Melatonin5 mg of Melatonin were given orally the night before operation. Another dose 90 min. preoperatively |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1- Patients in good general health. 2. Baseline MDAS <13. 3. No seizure disorder.
Key exclusion criteria (4 listed)
- Patients with a neurological disorder (e.g., dementia, stroke, epilepsy).
- Patients with a history of acute or chronic confusion.
- Patients taking centrally acting drugs (e.g., antidepressants, antiparkinsonian drugs, sedatives, monoamine oxidase inhibitors), or alcohol abusers.
- Patients who have medical disorders predisposing to delirium (e.g. cachexia, thyroid dysfunction, renal failure).
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 |
|---|---|---|
| MelatoninAlso: MidazolamThe patients were assessed using the Memorial Delirium Assessment Scale (MDAS) after the operation at 30, 60, and 90 min. Melatonin was shown to reduce delirium from 41.6% to 16.6% at 60 minutes, and the significant reduction was at 90 minutes (0%) when compared to both groups. Thus, melatonin was found to be successful in decreasing postoperative delirium when administered preoperatively. | Drug | Melatonin group |
| No interventionNo intervention was used. | Other | Control Group |
| Midazolam7.5 mg of Midazolam orally. | Drug | Midazolam group |
Primary outcome
The efficacy of oral Melatonin in preventing Postoperative Delirium after general anesthesia
Time frame: 1 week
This interventional trial is done to determine the efficacy of preoperative melatonin administration in reducing postoperative delirium rates.
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 11 Feb 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin and Midazolam in people with Delirium, Anesthesia Emergence and Delirium, run by University of Baghdad at 2 sites in Iraq.
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 1 inclusion and 4 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 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iraq. 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?
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?
The efficacy of oral Melatonin in preventing Postoperative Delirium after general anesthesia (time frame: 1 week). 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 11 Feb 2022.