Postoperative Neurocognitive DisordersNCT05613491
Intranasal Insulin Improves Postoperative Neurocognitive Disorders in Elderly Patients
A study testing Intranasal insulin and Intranasal saline in people with Postoperative Neurocognitive Disorders, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Postoperative neurocognitive disorders (PND) are common postoperative complication of central nervous system, leading to increased risk of the working ability loss after surgery, longer hospital stay, increased medical costs and increased surgical mortality. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Neurocognitive Disorders
- What is being tested?
- Intranasal insulin and Intranasal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 438 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2022to 31 Aug 2023
- 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
- Patients under general anesthesia through oral intubation;
- Patients undergoing elective extrathoracic, breast, orthopaedic, urological, abdominal and gynecological operations;
- Age ≥ 65 years;
- Cardiac function grade I~II (NYHA standard), ASA grade I~III;
- Volunteer for anticipating study and sign an informed consent form;
Who cannot join
- Diabetes patients;
- Previous history of craniocerebral and spinal cord trauma, surgery, stroke, and inability to place electrodes on the head;
- History of nasal cavity stuffiness, epistaxis, rhinitis, and nasopharynx surgery; The operation position is prone and it is difficult to implement intranasal administration;
- Those who cannot cooperate with the assessment of the scale or have delirium before operation;
- Preoperative fasting blood glucose<4 mmol/L;
- Those who have participated in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shannxi, 029710061
Qiang Wang, MD,PHD, 0086-18049286968, dr.wangqiang@163.com
About this study
Official title: Intranasal Insulin Improves Postoperative Neurocognitive Disorders in Elderly Patients: a Multicenter, Randomized, Double-blind, Placebo-controlled Study
Postoperative neurocognitive disorders (PND) are common postoperative complication of central nervous system, leading to increased risk of the working ability loss after surgery, longer hospital stay, increased medical costs and increased surgical mortality. It is classified as perioperative neurocognitive disorders in mental disorders.Aging is an important demographic characteristic in China, and the elderly is also a population susceptible to PND. There is a lack of targeted prevention and control measures for PND. Central insulin resistance is an important mechanism of cognitive impairment in elderly patients, and exogenous supply of central insulin may be an important measure to improve PND. Compared with conventional subcutaneous and intravenous supply, intranasal insulin administration not only has little effect on blood glucose and insulin levels, but also enters the center through the blood-brain barrier easily and efficiently. Long-term use of intranasal insulin can improve the cognitive function of chronic diseases, but there is a lack of clinical studies on improving PND by intranasal insulin. This study will verify the effectiveness of intranasal insulin in the PND improvement of elderly patients.
Read the detailed description
This study is intended to carry out a large sample, multicenter, double-blind, randomized, placebo, and controlled clinical study. Elderly non diabetes patients undergoing elective extrathoracic, breast, orthopedic, urinary, abdominal, and gynecological operations under general anesthesia are included. They are randomly divided into intranasal insulin group or saline group. Before anesthesia induction, they are given the first nasal spray, once per hour, 20 IU insulin or equal volume saline each time until the end of the operation. Follow up 1 day before operation, 1-7 days after operation, 30 days and 12 months respectively, and evaluate cognition with relevant scales. To verify that compared with the same volume of saline, intranasal insulin can reduce the incidence of postoperative delirium, the incidence of PND 1 year after surgery, and the related cognitive quantitative indicators of ApoE- ɛ4 Gene susceptibility, intraoperative EEG parameters, NfL, IL-6, IL-10, CRP and other biochemical indicators were used to explore the mechanism of intranasal insulin to improve PND.
- Conditions
- Postoperative Neurocognitive Disorders
- Being tested
- Intranasal insulin, Intranasal saline
- Keywords
- postoperative neurocognitive disorders, Intranasal insulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal insulinDrug
Also called Insulin injection，H10890001,Jiangsu Wanbang Biochemical Medicine Group Co., Ltd
Put insulin injection into nasal special drug delivery device.Before anesthesia induction, give the first insulin nasal spray, once per hour, 20 IU each time, until the end of the operation
Intranasal salineDrug
Also called 0.9% sodium chloride，H20013250,Shanghai Baite Medical Supplies Co., Ltd
Put 0.9% sodium chloride into nasal special drug delivery device.Before anesthesia induction, give the first equal volume saline nasal spray, once per hour, 20 IU each time, until the end of the operation
| Study group | Role | What they receive |
|---|---|---|
| Intranasal insulin group | Experimental | Before anesthesia induction, give the first insulin nasal spray, once per hour, 20 IU each time, until the end of the operation Receives: Drug: Intranasal insulin |
| Saline group | Placebo comparator | Before anesthesia induction, give the equal volumes'saline nasal spray, once per hour, 20 IU each time, until the end of the operation Receives: Drug: Intranasal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Whether or not postoperative delirium happens
Measured: 0-7 days after surgery
Secondary outcomes (6)
Incidence of delayed neurocognitive recovery within 30 days after surgery
Whether or not delayed neurocognitive recovery happens
Measured: 0-30 days after surgery
Incidence of neurocognitive disorders within 1 year after surgery
Whether or not neurocognitive disorders happens
Measured: 30 day-1 year after surgery
The PND Incidence
Whether or not postoperative neurocognitive disorders happensevents after surgery
Measured: 0 day-1 year after surgery
Intraoperative electroencephalogram parameters
The intraoperative parameters recorded by electroencephalogram, including BIS occurrence time, the duration with PSI less than 25, spectrum analysis, power spectrum analysis.
Measured: Surgery day
the level of Neurocognitive biomarkers
Neurocognitive biomarkers includes amyloid-beta protein and tau protein.
Measured: 0 day-1 year after surgery
ApoE-ε4 susceptibility
Whether or not carry ApoE-ε4
Measured: 1 day before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start7 Nov 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Postoperative Neurocognitive DisordersStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 438 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tang-Du Hospital, Tongji Hospital, Second Hospital of Shanxi Medical University, LanZhou University, Sichuan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, 521 Hospital of NORINCO Group
- Responsible party
- Sponsor
- Investigators
- Qiang Wang, MD,PHD, Study chair, First Affiliated Hospital of Xian JiaotongUniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613491
- Sponsor's protocol ID
- XJTU1AF2022LSK-265
- Status last verified
- Nov 2022
- First submitted
- 6 Nov 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research plan will not be made public until the research results are published
Publications
Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery-2018. Br J Anaesth. 2018 Nov;121(5):1005-1012. doi: 10.1016/j.bja.2017.11.087. Epub 2018 Jun 15.
PubMed 30336844Liu Y, Xiao W, Meng LZ, Wang TL. Geriatric Anesthesia-related Morbidity and Mortality in China: Current Status and Trend. Chin Med J (Engl). 2017 Nov 20;130(22):2738-2749. doi: 10.4103/0366-6999.218006.
PubMed 29133765Evered L, Scott DA, Silbert B, Maruff P. Postoperative cognitive dysfunction is independent of type of surgery and anesthetic. Anesth Analg. 2011 May;112(5):1179-85. doi: 10.1213/ANE.0b013e318215217e. Epub 2011 Apr 7.
PubMed 21474666Jayaraj RL, Azimullah S, Beiram R. Diabetes as a risk factor for Alzheimer's disease in the Middle East and its shared pathological mediators. Saudi J Biol Sci. 2020 Feb;27(2):736-750. doi: 10.1016/j.sjbs.2019.12.028. Epub 2019 Dec 26.
PubMed 32210695Li X, Run X, Wei Z, Zeng K, Liang Z, Huang F, Ke D, Wang Q, Wang JZ, Liu R, Zhang B, Wang X. Intranasal Insulin Prevents Anesthesia-induced Cognitive Impairments in Aged Mice. Curr Alzheimer Res. 2019;16(1):8-18. doi: 10.2174/1567205015666181031145045.
PubMed 30381076Chen Y, Dai CL, Wu Z, Iqbal K, Liu F, Zhang B, Gong CX. Intranasal Insulin Prevents Anesthesia-Induced Cognitive Impairment and Chronic Neurobehavioral Changes. Front Aging Neurosci. 2017 May 10;9:136. doi: 10.3389/fnagi.2017.00136. eCollection 2017.
PubMed 28539885Zhang Y, Dai CL, Chen Y, Iqbal K, Liu F, Gong CX. Intranasal Insulin Prevents Anesthesia-Induced Spatial Learning and Memory Deficit in Mice. Sci Rep. 2016 Feb 16;6:21186. doi: 10.1038/srep21186.
PubMed 26879001Claxton A, Baker LD, Hanson A, Trittschuh EH, Cholerton B, Morgan A, Callaghan M, Arbuckle M, Behl C, Craft S. Long-acting intranasal insulin detemir improves cognition for adults with mild cognitive impairment or early-stage Alzheimer's disease dementia. J Alzheimers Dis. 2015;44(3):897-906. doi: 10.3233/JAD-141791.
PubMed 25374101Benedict C, Hallschmid M, Schultes B, Born J, Kern W. Intranasal insulin to improve memory function in humans. Neuroendocrinology. 2007;86(2):136-42. doi: 10.1159/000106378. Epub 2007 Jul 20.
PubMed 17643054Chapman CD, Schioth HB, Grillo CA, Benedict C. Intranasal insulin in Alzheimer's disease: Food for thought. Neuropharmacology. 2018 Jul 1;136(Pt B):196-201. doi: 10.1016/j.neuropharm.2017.11.037. Epub 2017 Nov 24.
PubMed 29180222Benedict C, Hallschmid M, Hatke A, Schultes B, Fehm HL, Born J, Kern W. Intranasal insulin improves memory in humans. Psychoneuroendocrinology. 2004 Nov;29(10):1326-34. doi: 10.1016/j.psyneuen.2004.04.003.
PubMed 15288712Novak V, Milberg W, Hao Y, Munshi M, Novak P, Galica A, Manor B, Roberson P, Craft S, Abduljalil A. Enhancement of vasoreactivity and cognition by intranasal insulin in type 2 diabetes. Diabetes Care. 2014;37(3):751-9. doi: 10.2337/dc13-1672. Epub 2013 Oct 7.
PubMed 24101698Brunner YF, Kofoet A, Benedict C, Freiherr J. Central insulin administration improves odor-cued reactivation of spatial memory in young men. J Clin Endocrinol Metab. 2015 Jan;100(1):212-9. doi: 10.1210/jc.2014-3018.
PubMed 25337926
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Insulin Improves Postoperative Neurocognitive Disorders in Elderly Patients: a Multicenter, Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05613491
- Acronym / sponsor ID
- XJTU1AF2022LSK-265
- Conditions
- Postoperative Neurocognitive Disorders
- Keywords
- postoperative neurocognitive disorders, Intranasal insulin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 438 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Tang-Du Hospital, Tongji Hospital, Second Hospital of Shanxi Medical University, LanZhou University, Sichuan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, 521 Hospital of NORINCO Group
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 14 Nov 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 neurocognitive disorders (PND) are common postoperative complication of central nervous system, leading to increased risk of the working ability loss after surgery, longer hospital stay, increased medical costs and increased surgical mortality. It is classified as perioperative neurocognitive disorders in mental disorders.Aging is an important demographic characteristic in China, and the elderly is also a population susceptible to PND. There is a lack of targeted prevention and control measures for PND. Central insulin resistance is an important mechanism of cognitive impairment in elderly patients, and exogenous supply of central insulin may be an important measure to improve PND. Compared with conventional subcutaneous and intravenous supply, intranasal insulin administration not only has little effect on blood glucose and insulin levels, but also enters the center through the blood-brain barrier easily and efficiently. Long-term use of intranasal insulin can improve the cognitive function of chronic diseases, but there is a lack of clinical studies on improving PND by intranasal insulin. This study will verify the effectiveness of intranasal insulin in the PND improvement of elderly patients.
Detailed description
This study is intended to carry out a large sample, multicenter, double-blind, randomized, placebo, and controlled clinical study. Elderly non diabetes patients undergoing elective extrathoracic, breast, orthopedic, urinary, abdominal, and gynecological operations under general anesthesia are included. They are randomly divided into intranasal insulin group or saline group. Before anesthesia induction, they are given the first nasal spray, once per hour, 20 IU insulin or equal volume saline each time until the end of the operation. Follow up 1 day before operation, 1-7 days after operation, 30 days and 12 months respectively, and evaluate cognition with relevant scales. To verify that compared with the same volume of saline, intranasal insulin can reduce the incidence of postoperative delirium, the incidence of PND 1 year after surgery, and the related cognitive quantitative indicators of ApoE- ɛ4 Gene susceptibility, intraoperative EEG parameters, NfL, IL-6, IL-10, CRP and other biochemical indicators were used to explore the mechanism of intranasal insulin to improve PND.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal insulin group | Experimental | Drug: Intranasal insulinBefore anesthesia induction, give the first insulin nasal spray, once per hour, 20 IU each time, until the end of the operation |
| Saline group | Placebo comparator | Drug: Intranasal salineBefore anesthesia induction, give the equal volumes'saline nasal spray, once per hour, 20 IU each time, until the end of the operation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients under general anesthesia through oral intubation;
- Patients undergoing elective extrathoracic, breast, orthopaedic, urological, abdominal and gynecological operations;
- Age ≥ 65 years;
- Cardiac function grade I~II (NYHA standard), ASA grade I~III;
- Volunteer for anticipating study and sign an informed consent form;
Key exclusion criteria (6 listed)
- Diabetes patients;
- Previous history of craniocerebral and spinal cord trauma, surgery, stroke, and inability to place electrodes on the head;
- History of nasal cavity stuffiness, epistaxis, rhinitis, and nasopharynx surgery; The operation position is prone and it is difficult to implement intranasal administration;
- Those who cannot cooperate with the assessment of the scale or have delirium before operation;
- Preoperative fasting blood glucose<4 mmol/L;
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 |
|---|---|---|
| Intranasal insulinAlso: Insulin injection，H10890001,Jiangsu Wanbang Biochemical Medicine Group Co., LtdPut insulin injection into nasal special drug delivery device.Before anesthesia induction, give the first insulin nasal spray, once per hour, 20 IU each time, until the end of the operation | Drug | Intranasal insulin group |
| Intranasal salineAlso: 0.9% sodium chloride，H20013250,Shanghai Baite Medical Supplies Co., LtdPut 0.9% sodium chloride into nasal special drug delivery device.Before anesthesia induction, give the first equal volume saline nasal spray, once per hour, 20 IU each time, until the end of the operation | Drug | Saline group |
Primary outcome
Incidence of postoperative delirium
Time frame: 0-7 days after surgery
Whether or not postoperative delirium happens
6 secondary outcomes
Incidence of delayed neurocognitive recovery within 30 days after surgery
Time frame: 0-30 days after surgery
Incidence of neurocognitive disorders within 1 year after surgery
Time frame: 30 day-1 year after surgery
The PND Incidence
Time frame: 0 day-1 year after surgery
Intraoperative electroencephalogram parameters
Time frame: Surgery day
the level of Neurocognitive biomarkers
Time frame: 0 day-1 year after surgery
ApoE-ε4 susceptibility
Time frame: 1 day before surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Background: PubMed 30336844Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery-2018. Br J Anaesth. 2018 Nov;121(5):1005-1012. doi: 10.1016/j.bja.2017.11.087. Epub 2018 Jun 15.
- Background: PubMed 29133765Liu Y, Xiao W, Meng LZ, Wang TL. Geriatric Anesthesia-related Morbidity and Mortality in China: Current Status and Trend. Chin Med J (Engl). 2017 Nov 20;130(22):2738-2749. doi: 10.4103/0366-6999.218006.
- Background: PubMed 21474666Evered L, Scott DA, Silbert B, Maruff P. Postoperative cognitive dysfunction is independent of type of surgery and anesthetic. Anesth Analg. 2011 May;112(5):1179-85. doi: 10.1213/ANE.0b013e318215217e. Epub 2011 Apr 7.
- Background: PubMed 32210695Jayaraj RL, Azimullah S, Beiram R. Diabetes as a risk factor for Alzheimer's disease in the Middle East and its shared pathological mediators. Saudi J Biol Sci. 2020 Feb;27(2):736-750. doi: 10.1016/j.sjbs.2019.12.028. Epub 2019 Dec 26.
- Background: PubMed 30381076Li X, Run X, Wei Z, Zeng K, Liang Z, Huang F, Ke D, Wang Q, Wang JZ, Liu R, Zhang B, Wang X. Intranasal Insulin Prevents Anesthesia-induced Cognitive Impairments in Aged Mice. Curr Alzheimer Res. 2019;16(1):8-18. doi: 10.2174/1567205015666181031145045.
- Background: PubMed 28539885Chen Y, Dai CL, Wu Z, Iqbal K, Liu F, Zhang B, Gong CX. Intranasal Insulin Prevents Anesthesia-Induced Cognitive Impairment and Chronic Neurobehavioral Changes. Front Aging Neurosci. 2017 May 10;9:136. doi: 10.3389/fnagi.2017.00136. eCollection 2017.
- Background: PubMed 26879001Zhang Y, Dai CL, Chen Y, Iqbal K, Liu F, Gong CX. Intranasal Insulin Prevents Anesthesia-Induced Spatial Learning and Memory Deficit in Mice. Sci Rep. 2016 Feb 16;6:21186. doi: 10.1038/srep21186.
- Background: PubMed 25374101Claxton A, Baker LD, Hanson A, Trittschuh EH, Cholerton B, Morgan A, Callaghan M, Arbuckle M, Behl C, Craft S. Long-acting intranasal insulin detemir improves cognition for adults with mild cognitive impairment or early-stage Alzheimer's disease dementia. J Alzheimers Dis. 2015;44(3):897-906. doi: 10.3233/JAD-141791.
- Background: PubMed 17643054Benedict C, Hallschmid M, Schultes B, Born J, Kern W. Intranasal insulin to improve memory function in humans. Neuroendocrinology. 2007;86(2):136-42. doi: 10.1159/000106378. Epub 2007 Jul 20.
- Background: PubMed 29180222Chapman CD, Schioth HB, Grillo CA, Benedict C. Intranasal insulin in Alzheimer's disease: Food for thought. Neuropharmacology. 2018 Jul 1;136(Pt B):196-201. doi: 10.1016/j.neuropharm.2017.11.037. Epub 2017 Nov 24.
- Background: PubMed 15288712Benedict C, Hallschmid M, Hatke A, Schultes B, Fehm HL, Born J, Kern W. Intranasal insulin improves memory in humans. Psychoneuroendocrinology. 2004 Nov;29(10):1326-34. doi: 10.1016/j.psyneuen.2004.04.003.
- Background: PubMed 24101698Novak V, Milberg W, Hao Y, Munshi M, Novak P, Galica A, Manor B, Roberson P, Craft S, Abduljalil A. Enhancement of vasoreactivity and cognition by intranasal insulin in type 2 diabetes. Diabetes Care. 2014;37(3):751-9. doi: 10.2337/dc13-1672. Epub 2013 Oct 7.
- Individual participant dataSharing planned: Yes. The research plan will not be made public until the research results are published
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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.
Qiang Wang, MD,PHD study chair
First Affiliated Hospital of Xian JiaotongUniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intranasal insulin and Intranasal saline in people with Postoperative Neurocognitive Disorders, run by First Affiliated Hospital Xi'an Jiaotong University 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiang Wang, MD,PHD (0086-18049286968, dr.wangqiang@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: 0-7 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 NCT05613491, which also lists 13 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 14 Nov 2022.