Orthopedic SurgeryPhase 3DELIRLESSNCT04335968
Melatonin for Prevention of Postoperative Delirium After Lower Limb Fracture Surgery in Elderly Patients
A Phase 3 study testing Melatonin 4 mg in people with Orthopedic Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Postoperative delirium (POD) is one of the most frequent complications after surgery in elderly patients, affecting between 20 and 40% of patients older than 60 after major surgery. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Orthopedic Surgery
- What is being tested?
- Melatonin 4 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 357 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2021to 18 Apr 2025
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Demographic criteria: patient 70 years old or older
- Diagnostic criteria: isolated fracture of a lower limb
- Proximal femoral fractures: head, cervical, or trochanteric fractures
- Periprosthetic hip fracture
- Femoral shaft fracture
- Distal femoral fractures: supracondylar or condylar
Show all 10Show fewer
- Periprosthetic knee fracture
- Tibial plateau fracture
- Treatments/strategies/procedures: scheduled orthopedic surgery (osteosynthesis or arthroplasty)
- proxy or care giver knowing baseline cognitive status of the patient present or reachable by phone for an interview
Who cannot join
- Patient already taking Melatonin
- Contraindications and precaution for use of Melatonin administration:
- Hypersensitivity to the active substance or to any of the excipients of Circadin©
- Liver failure (presence of some of the following clinical and biological symptoms: icterus, asterixis, ascites, known esophageal varices, total bilirubin >20 micromol/L, FV <70%),
- Cirrhosis (known histological liver fibrosis)
- Renal failure with clearance <30 ml/min O Autoimmune disease O Hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome
Show all 17Show fewer
- Patients taking fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, oestrogenotherapy, quinolones, carbamazepine, rifampicin
- Other concomitant trauma than lower limb fracture(s)
- Surgery scheduled in more than 5 days
- Patient under mechanical ventilation
- Patient refusing to participate
- Patient not talking / understanding French (delirium assessment impossible)
- Patient already participating to another interventional study
- No signed informed consent,
- No affiliation to a social security regime
- Secondary Exclusion Criteria:
- Secondary exclusion (before randomization): diagnosis of delirium at the CAM assessment at inclusion, or creatinin clearance <30 ml / min and /or biological signs of hepatocellular insufficiency (bilirubin> 20 umol/l and factor V <70%) if samples not available during the anesthesiologist consultation and so performed after inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Melatonin for Prevention of Postoperative Delirium After Lower Limb Fracture Surgery in Elderly Patients: a Randomized Controlled Trial
Postoperative delirium (POD) is one of the most frequent complications after surgery in elderly patients, affecting between 20 and 40% of patients older than 60 after major surgery. This complication has huge consequences for the patients, families and society: increase of morbidity and mortality, prolonged length of stay, cognitive and functional decline leading to loss of autonomy, and important additional healthcare costs.
Among numerous risk factors identified, perioperative inflammatory stress is a key element in delirium genesis: surgical trauma releases danger signals in systemic circulation, activating immune cells and leading to neuroinflammation.
Read more
Melatonin is a neurohormone regulating circadian rhythm. But it also exhibits antioxidant and free radical scavenger properties, and regulates energy metabolism and immune function. It has already demonstrated a neuroprotective potential in various animal models. Its use against delirium is promising: it decreases delirium incidence in elderly patients hospitalized in medical ward, and several studies are now recruiting in ICU.
The hypothesis of the trial is that in a high-risk population, perioperative melatonin can reduce the incidence of POD.
The main objective is to evaluate the effect of perioperative melatonin administration on postoperative delirium incidence in the first 10 days after surgery, in elderly patients (over 70 years old) being hospitalized and scheduled for acute surgery of fractured lower limb (from femoral head to tibial plateau).
This is a prospective, national multicentric (24 centers), phase III, superiority, comparative randomized (1:1) double-blinded clinical trial with two parallel arms:
Experimental group: melatonin 4mg per os every night, starting the evening before surgery (or 2 hours before emergency surgery) and until day 5 after surgery.
Control group: placebo of this drug with the same schedule, during the same period of time.
The patients are aged 70 or older, hospitalized and scheduled for surgery of a severe fracture of a lower limb (from femoral head to tibial plateau).
Read the detailed description
Postoperative delirium (POD) is one of the most frequent complications after surgery in elderly patients, affecting between 20 and 40% of patients older than 60 after major surgery. This complication has huge consequences for the patients, families and society: increase of morbidity and mortality, prolonged length of stay, cognitive and functional decline leading to loss of autonomy, and important additional healthcare costs.
Among numerous risk factors identified, perioperative inflammatory stress is a key element in delirium genesis: surgical trauma releases danger signals in systemic circulation, activating immune cells and leading to neuroinflammation. In the brain, especially in hippocampus, proinflammatory cytokines, immune cells recruitment and microglial activation alter synaptic plasticity and lead to acute cognitive dysfunction. Moreover, with aging, an increase in initial neuroinflammatory response and a decrease in subsequent resolution phase are observed.
Melatonin is a neurohormone regulating circadian rhythm. But it also exhibits antioxidant and free radical scavenger properties, and regulates energy metabolism and immune function. It has already demonstrated a neuroprotective potential in various animal models. Its use against delirium is promising: it decreases delirium incidence in elderly patients hospitalized in medical ward, and several studies are now recruiting in ICU. Concerning the perioperative period, only two studies with conflicting results are available. The first one (Sultan, 2010), that has shown that melatonin decreases POD incidence, has strong methodological limitations (no calculated sample size, only 53 patients in melatonin group, all patients, even in the control group received melatonin if they developed POD, etc). In the second one (deJonghe, 2014), melatonin had no effect on POD incidence, but showed a reduction in the proportion of patients with POD exceeding 2 days. These conflicting results emphasize the need for a third RCT, with optimized methodology.
The hypothesis of the trial is that in a high-risk population, perioperative melatonin can reduce the incidence of POD.
The main objective is to evaluate the effect of perioperative melatonin administration on postoperative delirium incidence in the first 10 days after surgery, in elderly patients (over 70 years old) being hospitalized and scheduled for acute surgery of fractured lower limb (from femoral head to tibial plateau).
This is a prospective, national multicentric (24 centers), phase III, superiority, comparative randomized (1:1) double-blinded clinical trial with two parallel arms:
Experimental group: melatonin 4mg per os every night, starting the evening before surgery (or 2 hours before emergency surgery) and until day 5 after surgery.
Control group: placebo of this drug with the same schedule, during the same period of time.
The patients are aged 70 or older, hospitalized and scheduled for surgery of a severe fracture of a lower limb (from femoral head to tibial plateau).
An ancillary study is also planned in this study with the hypothesise that :
- Patients presenting post-operative delirium may exhibit significant perturbations of phenotypic and transcriptomic features of circulating leukocytes, of plasma levels of cytokines, and of oxidative stress level.
- Administration of melatonin may prevent these perturbations.
Ancillary study concerns Beaujon, Bichat and la Pitié centers.
- Conditions
- Orthopedic Surgery
- Being tested
- Melatonin 4 mg, Placebo oral tablet
- Keywords
- delirium, aging, Perioperative neurocognitive disorders, melatonine, orthopedic surgery
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 4 mgDrug
melatonin 4mg per os every night, starting the evening before surgery (or 2 hours before emergency surgery) and until day 5 after surgery.
Placebo oral tabletDrug
placebo of this drug with the same schedule, during the same period of time.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | melatonin 4mg per os every night, starting the evening before surgery (or 2 hours before emergency surgery) and until day 5 after surgery Receives: Drug: Melatonin 4 mg |
| Control group | Placebo comparator | placebo of this drug with the same schedule, during the same period of time. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium incidence
The Confusion Assessment Method (CAM) score, for patients hospitalized in surgery, or CAM-ICU score, for patients hospitalized in ICU will be applied daily during the first 10 days after surgery or end of hospital stay if shorter
Measured: 10 days after surgery
Secondary outcomes (14)
Number of days CAM positive
CAM will be applied daily during the first 10 days. the minimum 0 and maximum 4 values, and higher scores mean a worse outcome.
Measured: 10 days after surgery
Incidence of postoperative sedative or antipsychotic drugs administration from
Daily review of the medical chart and prescriptions looking for any sedative or antipsychotic drug administration
Measured: 10 days after surgery
Incidence of postoperative physical restrain prescription
Daily review of the medical chart and prescriptions looking for physical restraint prescription.
Measured: 10 days after surgery
Incidence of postoperative falls
Daily review of the medical chart and prescriptions looking for falls, whichever the gravity
Measured: 10 days after surgery
Mini Mental State Examination
Cognitive testing interview at bedside using the widely used French validated translation of the Mini Mental State Examination.
the minimum 0 and maximum 30 values, and higher scores mean a better outcome.
Measured: 10 days (or end of hospital stay if shorter)
Duration of hospital stay
Daily review of the medical file
Measured: 30 days after surgery
30 days postoperative mortality
Phone call (or visit for those who had not left the hospital) to the patient or caregivers
Measured: 30 days after surgery
30 days postoperative patient autonomy
Phone call (or visit for those who had not left the hospital) to the patient or caregivers and evaluation by the Katz Index of activities of daily living.
The minimum and maximum values are respectively 0 and 6, and higher scores mean a better outcome.
Measured: 30 days after surgery
30 days postoperative Quality of life
evaluated by EQ5D5L (standardized instrument for measuring generic health status : MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN/DISCOMFORT and ANXIETY/ DEPRESSION),) Questionnaire. the minimum 5 and maximum 125 values, and higher scores mean a better outcome.
Measured: 30 days after surgery
30 days postoperative QALYs (quality-adjusted life year)
QALYs (quality-adjusted life year) are the utility weights for the 30 day period x30/365. the minimum and maximum values are respectively 0 and1, and higher scores mean a better outcome.
Measured: 30 days after surgery
Total hospital costs at 30 days
calculated as the cumulative costs of all admissions (in- and outpatient, home care, rehabilitation) over a 30 day period
Measured: 30 days after surgery
Incremental cost effectiveness
The incremental cost effectiveness ratio is the difference in total costs divided by the difference in the incidence rate of delirium between the two arms
Measured: 30 days after surgery
cost utility ratios
the incremental cost utility ratio is the difference in total costs divided by the difference in QALYs (quality-adjusted life year)
Measured: 30 days after surgery
Occurrence of side effects
During the follow-up, daily interview of the patient and review of the medical chart will be performed, looking for side effects of melatonin.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start23 Jan 2021
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopedic SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, national multicentric (21 centers), phase III, superiority, comparative randomized (1:1) double-blinded clinical trial with two parallel arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie Sigaut, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335968
- Sponsor's protocol ID
- APHP180594
- Acronym
- DELIRLESS
- Status last verified
- May 2025
- First submitted
- 28 Feb 2020
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sigaut S, Couffignal C, Esposito-Farese M, Degos V, Molliex S, Boddaert J, Raynaud-Simon A, Durand-Zaleski I, Marcault E, Jacota M, Dahmani S, Paugam-Burtz C, Weiss E. Melatonin for prevention of postoperative delirium after lower limb fracture surgery in elderly patients (DELIRLESS): study protocol for a multicentre randomised controlled trial. BMJ Open. 2021 Dec 24;11(12):e053908. doi: 10.1136/bmjopen-2021-053908.
PubMed 34952881
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin for Prevention of Postoperative Delirium After Lower Limb Fracture Surgery in Elderly Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04335968
- Acronym / sponsor ID
- DELIRLESS / APHP180594
- Conditions
- Orthopedic Surgery
- Keywords
- delirium, aging, Perioperative neurocognitive disorders, melatonine, orthopedic surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 23 Jan 2021 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 7 Apr 2020 (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 (POD) is one of the most frequent complications after surgery in elderly patients, affecting between 20 and 40% of patients older than 60 after major surgery. This complication has huge consequences for the patients, families and society: increase of morbidity and mortality, prolonged length of stay, cognitive and functional decline leading to loss of autonomy, and important additional healthcare costs.
Among numerous risk factors identified, perioperative inflammatory stress is a key element in delirium genesis: surgical trauma releases danger signals in systemic circulation, activating immune cells and leading to neuroinflammation.
Melatonin is a neurohormone regulating circadian rhythm. But it also exhibits antioxidant and free radical scavenger properties, and regulates energy metabolism and immune function. It has already demonstrated a neuroprotective potential in various animal models. Its use against delirium is promising: it decreases delirium incidence in elderly patients hospitalized in medical ward, and several studies are now recruiting in ICU.
The hypothesis of the trial is that in a high-risk population, perioperative melatonin can reduce the incidence of POD.
The main objective is to evaluate the effect of perioperative melatonin administration on postoperative delirium incidence in the first 10 days after surgery, in elderly patients (over 70 years old) being hospitalized and scheduled for acute surgery of fractured lower limb (from femoral head to tibial plateau).
This is a prospective, national multicentric (24 centers), phase III, superiority, comparative randomized (1:1) double-blinded clinical trial with two parallel arms:
Experimental group: melatonin 4mg per os every night, starting the evening before surgery (or 2 hours before emergency surgery) and until day 5 after surgery.
Control group: placebo of this drug with the same schedule, during the same period of time.
The patients are aged 70 or older, hospitalized and scheduled for surgery of a severe fracture of a lower limb (from femoral head to tibial plateau).
Detailed description
Postoperative delirium (POD) is one of the most frequent complications after surgery in elderly patients, affecting between 20 and 40% of patients older than 60 after major surgery. This complication has huge consequences for the patients, families and society: increase of morbidity and mortality, prolonged length of stay, cognitive and functional decline leading to loss of autonomy, and important additional healthcare costs.
Among numerous risk factors identified, perioperative inflammatory stress is a key element in delirium genesis: surgical trauma releases danger signals in systemic circulation, activating immune cells and leading to neuroinflammation. In the brain, especially in hippocampus, proinflammatory cytokines, immune cells recruitment and microglial activation alter synaptic plasticity and lead to acute cognitive dysfunction. Moreover, with aging, an increase in initial neuroinflammatory response and a decrease in subsequent resolution phase are observed.
Melatonin is a neurohormone regulating circadian rhythm. But it also exhibits antioxidant and free radical scavenger properties, and regulates energy metabolism and immune function. It has already demonstrated a neuroprotective potential in various animal models. Its use against delirium is promising: it decreases delirium incidence in elderly patients hospitalized in medical ward, and several studies are now recruiting in ICU. Concerning the perioperative period, only two studies with conflicting results are available. The first one (Sultan, 2010), that has shown that melatonin decreases POD incidence, has strong methodological limitations (no calculated sample size, only 53 patients in melatonin group, all patients, even in the control group received melatonin if they developed POD, etc). In the second one (deJonghe, 2014), melatonin had no effect on POD incidence, but showed a reduction in the proportion of patients with POD exceeding 2 days. These conflicting results emphasize the need for a third RCT, with optimized methodology.
The hypothesis of the trial is that in a high-risk population, perioperative melatonin can reduce the incidence of POD.
The main objective is to evaluate the effect of perioperative melatonin administration on postoperative delirium incidence in the first 10 days after surgery, in elderly patients (over 70 years old) being hospitalized and scheduled for acute surgery of fractured lower limb (from femoral head to tibial plateau).
This is a prospective, national multicentric (24 centers), phase III, superiority, comparative randomized (1:1) double-blinded clinical trial with two parallel arms:
Experimental group: melatonin 4mg per os every night, starting the evening before surgery (or 2 hours before emergency surgery) and until day 5 after surgery.
Control group: placebo of this drug with the same schedule, during the same period of time.
The patients are aged 70 or older, hospitalized and scheduled for surgery of a severe fracture of a lower limb (from femoral head to tibial plateau).
An ancillary study is also planned in this study with the hypothesise that :
- Patients presenting post-operative delirium may exhibit significant perturbations of phenotypic and transcriptomic features of circulating leukocytes, of plasma levels of cytokines, and of oxidative stress level.
- Administration of melatonin may prevent these perturbations.
Ancillary study concerns Beaujon, Bichat and la Pitié centers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, national multicentric (21 centers), phase III, superiority, comparative randomized (1:1) double-blinded clinical trial with two parallel arms
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Melatonin 4 mgmelatonin 4mg per os every night, starting the evening before surgery (or 2 hours before emergency surgery) and until day 5 after surgery |
| Control group | Placebo comparator | Drug: Placebo oral tabletplacebo of this drug with the same schedule, during the same period of time. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Demographic criteria: patient 70 years old or older
- Diagnostic criteria: isolated fracture of a lower limb
- Treatments/strategies/procedures: scheduled orthopedic surgery (osteosynthesis or arthroplasty)
- proxy or care giver knowing baseline cognitive status of the patient present or reachable by phone for an interview
Key exclusion criteria (17 listed)
- Patient already taking Melatonin
- Contraindications and precaution for use of Melatonin administration:
- Other concomitant trauma than lower limb fracture(s)
- Surgery scheduled in more than 5 days
- Patient under mechanical ventilation
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 4 mgmelatonin 4mg per os every night, starting the evening before surgery (or 2 hours before emergency surgery) and until day 5 after surgery. | Drug | Experimental group |
| Placebo oral tabletplacebo of this drug with the same schedule, during the same period of time. | Drug | Control group |
Primary outcome
Postoperative delirium incidence
Time frame: 10 days after surgery
The Confusion Assessment Method (CAM) score, for patients hospitalized in surgery, or CAM-ICU score, for patients hospitalized in ICU will be applied daily during the first 10 days after surgery or end of hospital stay if shorter
14 secondary outcomes
Number of days CAM positive
Time frame: 10 days after surgery
Incidence of postoperative sedative or antipsychotic drugs administration from
Time frame: 10 days after surgery
Incidence of postoperative physical restrain prescription
Time frame: 10 days after surgery
Incidence of postoperative falls
Time frame: 10 days after surgery
Mini Mental State Examination
Time frame: 10 days (or end of hospital stay if shorter)
Duration of hospital stay
Time frame: 30 days after surgery
30 days postoperative mortality
Time frame: 30 days after surgery
30 days postoperative patient autonomy
Time frame: 30 days after surgery
30 days postoperative Quality of life
Time frame: 30 days after surgery
30 days postoperative QALYs (quality-adjusted life year)
Time frame: 30 days after surgery
Total hospital costs at 30 days
Time frame: 30 days after surgery
Incremental cost effectiveness
Time frame: 30 days after surgery
cost utility ratios
Time frame: 30 days after surgery
Occurrence of side effects
Time frame: 30 days after surgery
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 8 Sep 2025.
- Derived from this study: PubMed 34952881Sigaut S, Couffignal C, Esposito-Farese M, Degos V, Molliex S, Boddaert J, Raynaud-Simon A, Durand-Zaleski I, Marcault E, Jacota M, Dahmani S, Paugam-Burtz C, Weiss E. Melatonin for prevention of postoperative delirium after lower limb fracture surgery in elderly patients (DELIRLESS): study protocol for a multicentre randomised controlled trial. BMJ Open. 2021 Dec 24;11(12):e053908. doi: 10.1136/bmjopen-2021-053908.
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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.
Stéphanie Sigaut principal investigator
APHP
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 4 mg in people with Orthopedic Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 10 inclusion and 17 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 8 Sep 2025. 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 France. 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 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?
Postoperative delirium incidence (time frame: 10 days after surgery). 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 NCT04335968, which also lists 1 linked publication.
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 8 Sep 2025.