Postoperative Delirium (POD)EPISODENCT06900205
Effects of Esketamine on the Incidence of Postoperative Delirium and Postoperative Sleep Disturbance in Elderly Patients After Major Non-cardiac Surgery
A study testing Esketamine and 0.9 % saline in people with Postoperative Delirium (POD) and Postoperative Sleep Disturbance, run by RenJi Hospital at 1 site in China.
Trial summary
Postoperative delirium (POD) is a common surgical complication.It is associated with a range of negative outcomes such as delayed postoperative recovery,prolonged hospitalization,additional medical expenditures and higher mortality. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium (POD), Postoperative Sleep Disturbance
- What is being tested?
- Esketamine and 0.9 % saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 30 Sep 2026
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≧ 65 years;
- ASA Ⅰ-Ⅲ;
- Elective major non-cardiac surgery;
- Voluntary signed informed consent.
Who cannot join
- People with mental illness;
- Suffering from serious central nervous system disorders such as arkinson's disease, Alzheimer's disease, etc;
- Elevated intracranial pressure;
- Emergency or trauma surgery;
- Prior history of postoperative delirium or postoperative cognitive decline;
- The patient has impaired hearing or impaired vision;
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- Suffering from severe systemic underlying diseases (e.g. cardiac insufficiency, malignant arrhythmia, malignant hypertension, hepatic failure, renal failure, etc.);
- The patient is in chronic pain;
- The patient is severely malnourished;
- Patients with stage 3 or 4 malignant tumors, pancreatic cancer, allbladder cancer, cholangiocarcinoma and other tumors with high malignancy and poor prognosis.
- history of allergy to or contraindication to esketamine;
- inability or unwillingness to complete questionnaires or clinical testing;
- Unable or unwilling to use a postoperative intravenous analgesic pump.
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Effects of Esketamine on the Incidence of Postoperative Delirium and Postoperative Sleep Disturbance in Elderly Patients After Major Non-cardiac Surgery: A Multi-Center Randomized Controlled Trial
Postoperative delirium (POD) is a common surgical complication.It is associated with a range of negative outcomes such as delayed postoperative recovery,prolonged hospitalization,additional medical expenditures and higher mortality.
Meanwhile,sleep disorders are not only an important predisposing factor for delirium,but also one of the main symptoms of delirium.Systemic inflammatory responses caused by sleep disorders may be an important mechanism for POD.
Read more
Many studies have shown that esketamie may inhibit inflammatory factors and enhance neuroplasticity.
In summary,we felt the need to further explore the therapeutic potential of esketamine in the area of POD as well as postoperative sleep disorders.
- Being tested
- Esketamine, 0.9 % saline
- Keywords
- esketamine, non-cardiac surgery, Postoperative Delirium (POD), Postoperative Sleep Disturbance
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
loading dose:intravenous infusion of 0.25mg/kg esketamine after induction of aneshtesia; postoperative intravenous analgesia:1.5ug/kg sufentail+1mg/kg esketamine diluted into 100ml will be provided to the patients after surgery at a rate of 2ml/h for 48h.
0.9 % salineDrug
loading dose:intravenous infusion the same volume of 0.9% saline as the other group after induction of aneshtesia; postoperative intravenous analgesia:1.5ug/kg sufentail diluted into 100ml will be provided to the patients after surgery at a rate of 2ml/h for 48h.
| Study group | Role | What they receive |
|---|---|---|
| esketamine group | Experimental | The esketamine group patients will be received esketamine perioperatively. Receives: Drug: Esketamine |
| Placebo group | Placebo comparator | The placebo group patients will be received 0.9% saline perioperatively. Receives: Drug: 0.9 % saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative delirium
Postoperative delirium is assessed by the 3-minute diagnostic interview for CAM (3D-CAM) or the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) as applicable.
Measured: postoperative 7 day
The incidence of postoperative sleep disturbance
Postoperative sleep disturbance is evaluated by the Athens Insomnia Scale (AIS).
The AIS is a self-rated psychometric questionnaire to quantify sleep difficulties according to the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision criteria.
The AIS consists of 8 items: waking up at night, sleep induction, final awakening, total sleep duration, sleep quality, well-being, functional ability, and daytime sleepiness.
The AIS score ranges from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.
Measured: postoperative 3 day
Secondary outcomes (3)
The incidence of postoperative cognitive dysfunction
Postoperative delirium is assessed by the Montreal Cognitive Assessment (MoCA).
MoCA scale was widely identified in the detection of mild cognitive impairment. MoCA assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
The total possible score is 30 points; a score of 26 or above is considered normal.
Measured: 7 days after surgery and 90 days after surgery
postoperative pain severity score
The degree of surgical incision pain will be assessed at rest and on movement by Visual Analogue Scale (VAS). VAS ranges from 0 to 10, with the highest score indicating the worst pain.
Measured: 2 hours after surgery、postoperative 3 day and 90 days after surgery
The incidence of postoperative adverse reactions
Postoperative adverse reactions within 90 days were defined as postoperative adverse reactions that are new, have an adverse effect on the patient, and require medical intervention (including psychiatric system symptoms, 30-day all-cause mortality etc.).
Measured: postoperative 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Why it stopped: The trial protocol has undergone substantial revisions, including modifications to the primary outcome measure, which fundamentally alter the original study objectives. As these changes are not compatible with the initial registration, we
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postoperative Delirium (POD)Studies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Drug: Esketamine After anesthesia induction intubation and before surgery,0.25mg/kg esketamine will be diluted into a 10ml syringe and injected intravenously. After surgery,a postoperative intravenous analgesia pump will be given with the following drugs and dosages:sufentanil 1.5ug/kg,esketaminge 1.0mg/kg and tolansetron 5mg, diluted into100ml at 2ml/h for 48h. Drug: 0.9% saline After anesthesia induction intubation and before surgery,10ml of 0.9% saline will be injected intravenously. After surgery,a postoperative intravenous analgesia pump will be given with the following drugs and dosages:sufentanil 1.5ug/kg and tolansetron 5mg, diluted into100ml at 2ml/h for 48h.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Chest Hospital, Xuhui Central Hospital, Shanghai
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900205
- Sponsor's protocol ID
- 2025-026
- Acronym
- EPISODE
- Status last verified
- May 2025
- First submitted
- 23 Mar 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and de-identified individual participant data could be shared after 1 year after publication with the permission of principle investigator for reasonable usage.
Publications
Xiong X, Shao Y, Chen D, Chen B, Lan X, Shi J. Effect of Esketamine on Postoperative Delirium in Patients Undergoing Cardiac Valve Replacement with Cardiopulmonary Bypass: A Randomized Controlled Trial. Anesth Analg. 2024 Oct 1;139(4):743-753. doi: 10.1213/ANE.0000000000006925. Epub 2024 Mar 6.
PubMed 38446699Luo T, Deng Z, Ren Q, Mu F, Zhang Y, Wang H. Effects of esketamine on postoperative negative emotions and early cognitive disorders in patients undergoing non-cardiac thoracic surgery: A randomized controlled trial. J Clin Anesth. 2024 Aug;95:111447. doi: 10.1016/j.jclinane.2024.111447. Epub 2024 Mar 23.
PubMed 38522144Zhang A, Zhou Y, Zheng X, Zhou W, Gu Y, Jiang Z, Yao Y, Wei W. Effects of S-ketamine added to patient-controlled analgesia on early postoperative pain and recovery in patients undergoing thoracoscopic lung surgery: A randomized double-blinded controlled trial. J Clin Anesth. 2024 Feb;92:111299. doi: 10.1016/j.jclinane.2023.111299. Epub 2023 Nov 7.
PubMed 37939610Sadeghirad B, Dodsworth BT, Schmutz Gelsomino N, Goettel N, Spence J, Buchan TA, Crandon HN, Baneshi MR, Pol RA, Brattinga B, Park UJ, Terashima M, Banning LBD, Van Leeuwen BL, Neerland BE, Chuan A, Martinez FT, Van Vugt JLA, Rampersaud YR, Hatakeyama S, Di Stasio E, Milisen K, Van Grootven B, van der Laan L, Thomson Mangnall L, Goodlin SJ, Lungeanu D, Denhaerynck K, Dhakharia V, Sampson EL, Zywiel MG, Falco L, Nguyen AV, Moss SJ, Krewulak KD, Jaworska N, Plotnikoff K, Kotteduwa-Jayawarden S, Sandarage R, Busse JW, Mbuagbaw L. Perioperative Factors Associated With Postoperative Delirium in Patients Undergoing Noncardiac Surgery: An Individual Patient Data Meta-Analysis. JAMA Netw Open. 2023 Oct 2;6(10):e2337239. doi: 10.1001/jamanetworkopen.2023.37239.
PubMed 37819663Mevorach L, Forookhi A, Farcomeni A, Romagnoli S, Bilotta F. Perioperative risk factors associated with increased incidence of postoperative delirium: systematic review, meta-analysis, and Grading of Recommendations Assessment, Development, and Evaluation system report of clinical literature. Br J Anaesth. 2023 Feb;130(2):e254-e262. doi: 10.1016/j.bja.2022.05.032. Epub 2022 Jul 7.
PubMed 35810005Sprung J, Roberts RO, Weingarten TN, Nunes Cavalcante A, Knopman DS, Petersen RC, Hanson AC, Schroeder DR, Warner DO. Postoperative delirium in elderly patients is associated with subsequent cognitive impairment. Br J Anaesth. 2017 Aug 1;119(2):316-323. doi: 10.1093/bja/aex130.
PubMed 28854531Qiu D, Wang XM, Yang JJ, Chen S, Yue CB, Hashimoto K, Yang JJ. Effect of Intraoperative Esketamine Infusion on Postoperative Sleep Disturbance After Gynecological Laparoscopy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2244514. doi: 10.1001/jamanetworkopen.2022.44514.
PubMed 36454569Avidan MS, Maybrier HR, Abdallah AB, Jacobsohn E, Vlisides PE, Pryor KO, Veselis RA, Grocott HP, Emmert DA, Rogers EM, Downey RJ, Yulico H, Noh GJ, Lee YH, Waszynski CM, Arya VK, Pagel PS, Hudetz JA, Muench MR, Fritz BA, Waberski W, Inouye SK, Mashour GA; PODCAST Research Group. Intraoperative ketamine for prevention of postoperative delirium or pain after major surgery in older adults: an international, multicentre, double-blind, randomised clinical trial. Lancet. 2017 Jul 15;390(10091):267-275. doi: 10.1016/S0140-6736(17)31467-8. Epub 2017 May 30.
PubMed 28576285
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Esketamine on the Incidence of Postoperative Delirium and Postoperative Sleep Disturbance in Elderly Patients After Major Non-cardiac Surgery: A Multi-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06900205
- Acronym / sponsor ID
- EPISODE / 2025-026
- Keywords
- esketamine, non-cardiac surgery, Postoperative Delirium (POD), Postoperative Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The trial protocol has undergone substantial revisions, including modifications to the primary outcome measure, which fundamentally alter the original study objectives. As these changes are not compatible with the initial registration, we
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Chest Hospital, Xuhui Central Hospital, Shanghai
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 28 Mar 2025 (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 a common surgical complication.It is associated with a range of negative outcomes such as delayed postoperative recovery,prolonged hospitalization,additional medical expenditures and higher mortality.
Meanwhile,sleep disorders are not only an important predisposing factor for delirium,but also one of the main symptoms of delirium.Systemic inflammatory responses caused by sleep disorders may be an important mechanism for POD.
Many studies have shown that esketamie may inhibit inflammatory factors and enhance neuroplasticity.
In summary,we felt the need to further explore the therapeutic potential of esketamine in the area of POD as well as postoperative sleep disorders.
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
- Drug: Esketamine After anesthesia induction intubation and before surgery,0.25mg/kg esketamine will be diluted into a 10ml syringe and injected intravenously. After surgery,a postoperative intravenous analgesia pump will be given with the following drugs and dosages:sufentanil 1.5ug/kg,esketaminge 1.0mg/kg and tolansetron 5mg, diluted into100ml at 2ml/h for 48h. Drug: 0.9% saline After anesthesia induction intubation and before surgery,10ml of 0.9% saline will be injected intravenously. After surgery,a postoperative intravenous analgesia pump will be given with the following drugs and dosages:sufentanil 1.5ug/kg and tolansetron 5mg, diluted into100ml at 2ml/h for 48h.
| Arm | Type | Receives |
|---|---|---|
| esketamine group | Experimental | Drug: EsketamineThe esketamine group patients will be received esketamine perioperatively. |
| Placebo group | Placebo comparator | Drug: 0.9 % salineThe placebo group patients will be received 0.9% saline perioperatively. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≧ 65 years;
- ASA Ⅰ-Ⅲ;
- Elective major non-cardiac surgery;
- Voluntary signed informed consent.
Key exclusion criteria (13 listed)
- People with mental illness;
- Suffering from serious central nervous system disorders such as arkinson's disease, Alzheimer's disease, etc;
- Elevated intracranial pressure;
- Emergency or trauma surgery;
- Prior history of postoperative delirium or postoperative cognitive decline;
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 |
|---|---|---|
| Esketamineloading dose:intravenous infusion of 0.25mg/kg esketamine after induction of aneshtesia; postoperative intravenous analgesia:1.5ug/kg sufentail+1mg/kg esketamine diluted into 100ml will be provided to the patients after surgery at a rate of 2ml/h for 48h. | Drug | esketamine group |
| 0.9 % salineloading dose:intravenous infusion the same volume of 0.9% saline as the other group after induction of aneshtesia; postoperative intravenous analgesia:1.5ug/kg sufentail diluted into 100ml will be provided to the patients after surgery at a rate of 2ml/h for 48h. | Drug | Placebo group |
Primary outcome
The incidence of postoperative delirium
Time frame: postoperative 7 day
Postoperative delirium is assessed by the 3-minute diagnostic interview for CAM (3D-CAM) or the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) as applicable.
The incidence of postoperative sleep disturbance
Time frame: postoperative 3 day
Postoperative sleep disturbance is evaluated by the Athens Insomnia Scale (AIS). The AIS is a self-rated psychometric questionnaire to quantify sleep difficulties according to the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision criteria. The AIS consists of 8 items: waking up at night, sleep induction, final awakening, total sleep duration, sleep quality, well-being, functional ability, and daytime sleepiness. The AIS score ranges from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.
3 secondary outcomes
The incidence of postoperative cognitive dysfunction
Time frame: 7 days after surgery and 90 days after surgery
postoperative pain severity score
Time frame: 2 hours after surgery、postoperative 3 day and 90 days after surgery
The incidence of postoperative adverse reactions
Time frame: postoperative 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 38446699Xiong X, Shao Y, Chen D, Chen B, Lan X, Shi J. Effect of Esketamine on Postoperative Delirium in Patients Undergoing Cardiac Valve Replacement with Cardiopulmonary Bypass: A Randomized Controlled Trial. Anesth Analg. 2024 Oct 1;139(4):743-753. doi: 10.1213/ANE.0000000000006925. Epub 2024 Mar 6.
- Background: PubMed 38522144Luo T, Deng Z, Ren Q, Mu F, Zhang Y, Wang H. Effects of esketamine on postoperative negative emotions and early cognitive disorders in patients undergoing non-cardiac thoracic surgery: A randomized controlled trial. J Clin Anesth. 2024 Aug;95:111447. doi: 10.1016/j.jclinane.2024.111447. Epub 2024 Mar 23.
- Background: PubMed 37939610Zhang A, Zhou Y, Zheng X, Zhou W, Gu Y, Jiang Z, Yao Y, Wei W. Effects of S-ketamine added to patient-controlled analgesia on early postoperative pain and recovery in patients undergoing thoracoscopic lung surgery: A randomized double-blinded controlled trial. J Clin Anesth. 2024 Feb;92:111299. doi: 10.1016/j.jclinane.2023.111299. Epub 2023 Nov 7.
- Background: PubMed 37819663Sadeghirad B, Dodsworth BT, Schmutz Gelsomino N, Goettel N, Spence J, Buchan TA, Crandon HN, Baneshi MR, Pol RA, Brattinga B, Park UJ, Terashima M, Banning LBD, Van Leeuwen BL, Neerland BE, Chuan A, Martinez FT, Van Vugt JLA, Rampersaud YR, Hatakeyama S, Di Stasio E, Milisen K, Van Grootven B, van der Laan L, Thomson Mangnall L, Goodlin SJ, Lungeanu D, Denhaerynck K, Dhakharia V, Sampson EL, Zywiel MG, Falco L, Nguyen AV, Moss SJ, Krewulak KD, Jaworska N, Plotnikoff K, Kotteduwa-Jayawarden S, Sandarage R, Busse JW, Mbuagbaw L. Perioperative Factors Associated With Postoperative Delirium in Patients Undergoing Noncardiac Surgery: An Individual Patient Data Meta-Analysis. JAMA Netw Open. 2023 Oct 2;6(10):e2337239. doi: 10.1001/jamanetworkopen.2023.37239.
- Background: PubMed 35810005Mevorach L, Forookhi A, Farcomeni A, Romagnoli S, Bilotta F. Perioperative risk factors associated with increased incidence of postoperative delirium: systematic review, meta-analysis, and Grading of Recommendations Assessment, Development, and Evaluation system report of clinical literature. Br J Anaesth. 2023 Feb;130(2):e254-e262. doi: 10.1016/j.bja.2022.05.032. Epub 2022 Jul 7.
- Background: PubMed 28854531Sprung J, Roberts RO, Weingarten TN, Nunes Cavalcante A, Knopman DS, Petersen RC, Hanson AC, Schroeder DR, Warner DO. Postoperative delirium in elderly patients is associated with subsequent cognitive impairment. Br J Anaesth. 2017 Aug 1;119(2):316-323. doi: 10.1093/bja/aex130.
- Results publication: PubMed 36454569Qiu D, Wang XM, Yang JJ, Chen S, Yue CB, Hashimoto K, Yang JJ. Effect of Intraoperative Esketamine Infusion on Postoperative Sleep Disturbance After Gynecological Laparoscopy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2244514. doi: 10.1001/jamanetworkopen.2022.44514.
- Results publication: PubMed 28576285Avidan MS, Maybrier HR, Abdallah AB, Jacobsohn E, Vlisides PE, Pryor KO, Veselis RA, Grocott HP, Emmert DA, Rogers EM, Downey RJ, Yulico H, Noh GJ, Lee YH, Waszynski CM, Arya VK, Pagel PS, Hudetz JA, Muench MR, Fritz BA, Waberski W, Inouye SK, Mashour GA; PODCAST Research Group. Intraoperative ketamine for prevention of postoperative delirium or pain after major surgery in older adults: an international, multicentre, double-blind, randomised clinical trial. Lancet. 2017 Jul 15;390(10091):267-275. doi: 10.1016/S0140-6736(17)31467-8. Epub 2017 May 30.
- Individual participant dataSharing planned: Yes. Study protocol and de-identified individual participant data could be shared after 1 year after publication with the permission of principle investigator for reasonable usage.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine and 0.9 % saline in people with Postoperative Delirium (POD) and Postoperative Sleep Disturbance, run by RenJi Hospital at 1 site in China.
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 4 inclusion and 13 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: withdrawn, as of the sponsor's last update on 16 May 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 China. 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 was withdrawn before enrolling participants, so there are no results.
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 incidence of postoperative delirium (time frame: postoperative 7 day). The study lists 2 primary outcomes in all. 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 NCT06900205, which also lists 8 linked publications.
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 16 May 2025.