Delirium in Old AgePhase 4NCT03346226
How Different Sedatives Affect Hip Fracture Patient's Postoperative Delirium
A Phase 4 study testing Dexmedetomidine Hydrochloride and Propofol in people with Delirium in Old Age, run by Shanghai Zhongshan Hospital.
Trial summary
the hypothesis is that Dexmedetomidine seems to decrease incidence of post-operative delirium . one possible mechanism is that Dex have a minor influence on cognition, since it has no effect on GABA receptor，another is that Dex could induce a sleep similar to natural sleep, thereby decreasing sleep deprivation and… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Delirium in Old Age
- What is being tested?
- Dexmedetomidine Hydrochloride and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 30 Jun 2019
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Acquisition of informed consent,
- Patients with hip fracture surgery under lumbar anesthesia,
- Grade II to III based on American Society of Anesthesiologists ASA classification,
- Age ≥65 and ≤90 years old.
Who cannot join
- History of psychiatric disease or a disease needing long-term exposure to psychotropic drugs (dementia, schizophrenia), or history of alcoholic abuse.
- More than 8 errors in preoperative Simplified Psychology and Mental Status Questionnaire (SPMSQ) , and diagnosed as severe cognitive impairment.
- CAM positive diagnosed preoperatively.
- Any cerebrovascular accident occurring within 3 months, such as cerebral stroke or transient ischemic attack (TIA).
- Systolic pressure < 90mmHg and diastolic pressure < 60mm Hg at the preoperative follow up or HR< 50/minute.
- History of heat failure or EF<30% as shown by ultrasound cardiogram; degree 2 type 2 and degree 3 atrioventricular block. History of active heart disease (such as acute cardiac infarction, unstable angina pectoris)
Show all 14Show fewer
- Severe abnormality in hepatic or renal function (severe abnormality in liver function: more than 2-times increase than upper normal limit in any one of the markers including ALT,, conjugated bilirubin, AST, ALP, total bilirubin; severe abnormality in renal function; Cr clearance<30ml/min), Scr>443μmol/L.
- Diabetes patients with severe complications of diabetes (Diabetic ketoacidosis, hyperosmolar coma, various infections, macrovascular diseases, and diabetic nephropathy)
- Patients with severe infection.
- Postoperative PaO2<60mmHg or SpO2<92%.
- Participation in clinical trials of other drugs within past 30 days.
- Disturbed verbal communication, and unable to accomplish the test on cognition.
- Patients with prosthesis fracture or restoration; hip fracture but complicated with severe trauma in other sites.
- Being allergic to investigational drug or having contradiction of lumbar anesthesia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Influence on Incidence of Postoperative Delirium by Various Sedatives in Elderly Patients With Hip Fracture Under Lumbar Anesthesia: A Randomized, Control and Multi-center Trial
the hypothesis is that Dexmedetomidine seems to decrease incidence of post-operative delirium . one possible mechanism is that Dex have a minor influence on cognition, since it has no effect on GABA receptor，another is that Dex could induce a sleep similar to natural sleep, thereby decreasing sleep deprivation and circadian rhythm disorder in post-operative patients.
In this study , investigators devise the two different sedatives(Dexmedetomidine and Propofol)'influence on postoperative delirium in hip fracture elderly participants under spinal anesthesia
Read the detailed description
With a complex etiology, delirium is usually caused by various peri-operative stimuli on basis of predisposing factors, including senility, hypoxia and hypotension, pain, drug (such as pethidine, benzodiazepine, anticholinergic, and drug withdrawal), complications prior to surgery, post-operative sleep disorder. As for the mechanism of delirium, the commonly accepted hypothesis includes the decreased central cholinergic neurons function and the inflammation of central nervous system. Most of the hip fracture patients are senile, suffering generally from many complications with exposure to many drugs, and poor in nutritional status with decreased cognitive function even before the surgery in some of them, all of which are risk factors for post-operative delirium. Systematic review suggests that incidence of POD in patients undergoing elective hip arthroplasty is up to 4-53.3%. It is of great importance, therefore, to explore the effective approaches to lower POD incidence in senile patients with operation on hip fracture.
Dexmedetomidine Hydrochloride is a novel highly-selective α2 adrenergic receptor agonist, and its selectivity to α2 receptor is 8 times of that of clonidine. It has multiple functions including sedation, anti-anxiety, hypnosis, analgesia and sympathetic blockade, with a wide application prospect for peri-operative patients. Researches suggest that Dex applied peri-operatively may stabilize blood pressure and heart rate, control intra-operative stress, and decrease post-operative side reactions such as nausea, vomiting, restlessness, delirium and chills. Moreover, advantages of Dex also include analgesia and reduction of opioid usage. Clinical pharmacological characteristics of Dex suggest its possible function to decrease post-operative delirium. Meanwhile, Dex seems to have a minor influence on cognition, since it has no effect on GABA receptor.
Another important feature of it is that Dex induces a sleep similar to natural sleep, thereby decreasing sleep deprivation and circadian rhythm disorder in post-operative patients, and decreasing incidence of post-operative delirium. Researches evaluating the capability of Dex to decrease delirium incidence are focused on ICU sedation post to operation. Riker et al compared the sedative effect between Dex and midazolam in patients with severe mechanical ventilation, revealing a lower delirium incidence in Dex than in midazolam (54.0% vs 76.6%) in patients maintained with the same depth of sedation. Systematic review concludes that Dex in effective to prevent and treat post-operative delirium in ICU patients.
In this study ,the investigators devise the two different sedatives (Dexmedetomidine and Propofol)'influence on postoperative delirium in hip fracture elderly participants under spinal anesthesia
- Conditions
- Delirium in Old Age
- Being tested
- Dexmedetomidine Hydrochloride, Propofol
- Keywords
- Delirium Dexmedetomidine elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine HydrochlorideDrug
Also called brand name ：YiSi
Dexmedetomidine is given to patients during spinal anesthesia at the dose of 0.5 μg/kg，adjusted the dose to keep BIS between 70-80 until 30 minutes before the end of surgery
PropofolDrug
Also called Brand name：Diprivan or other brands of propofol
Propofol is given with an initial ratio of 2-10mg/kg/h, when the operation starts，adjust the propofol's dose to keep BIS between 70-80 before the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Hydrochloride | Experimental | Dex Group: 0.5 μg/kg of Dex is given 10 minutes before operation through injection pump during 15 minutes. After the operation starts, the initial pumping ratio of Dex is 0.5ug/kg/h and adjusted under BIS surveillance to keep BIS between 70-80 until 30 minutes before the end of surgery. Meanwhile, OAA/S grade is evaluated every 15 minutes to maintain OAA/S at grade 4. If discrepancy occurs, OAA/S prevails. Receives: Drug: Dexmedetomidine Hydrochloride |
| Propofol | Active comparator | Prop Group: Propofol is given with an initial ratio of 2-10mg/kg/h, when the operation starts. Under BIS surveillance, dripping rate is adjusted to keep BIS between 70-80 until 5 minutes before the end of surgery. Meanwhile, OAA/S grade is evaluated every 15 minutes to maintain OAA/S at grade 4. If discrepancy occurs, OAA/S prevails. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of postoperative delirium in postoperative 72 hours
Evaluation of delirium is performed by trained investigational assistant who does not know the randomization of patients. Follow up is carried out before operation and at 9Am and 3Pm during post-operative day 1-3 (POD1-3). During follow up, RASS (Richmond Agitation-Sedation Scale, RASS) is used firstly to evaluate sedation of the patients, and for those with ARSS >-4 (-3～+4), the Confusion Assessment Method (CAM) is adopted for evaluation. A case consistent with delirium standard at any time point during follow up is determined to be delirium positive. Diagnosis should be confirmed for a CAM-positive patient by a psychological expert based on DSM-V standard
Measured: patient enrolled will be evaluated at 9Am and 3Pm during post-operative day 1-3 (POD1-3).At any time point above，delirium is detected，then the patient will be diagnosed as postoperative delirium. All patients enrolled is Non-delirium before surgery。
Secondary outcomes (7)
Consumption of analgesic
the patients will receive patient-controlled intravenous analgesia，record the consumption of intravenous analgesia in the 48 postoperative hours
Measured: record the data of comsumption of analgeisic at 48 hours after operation
Times of intra-operative occurrence of hypotension, bradycardia, hypertension and tachycardia that need treatment.
assess the adverse effect of anaesthetic
Measured: during the operation
Score of quality of post-operative sleeping
Score of sleeping quality is evaluated based on the some questions during follow up
Measured: quality of sleeping will be assessed at 9Am during post-operative day 1-3
Hospital stay
the duration from the day of operation to the date meeting discharge criteria as determined by doctor in charge
Measured: record the days of hospital stay at the 30 days after surgery
Post-operative complications besides delirium
complications besides delirium ，such as vomiting，nausea，hypotention，hypertention，bradycardia
Measured: observe and evaluate complications at the 30 days after surgery
Mortality up to day 30 post to operation
Data for 30-day survival is collected through telephone follow up by the assistant.
Measured: the data will be collected after 30 days of operation
pain score
describe severity of the pain the patient feel using Numerical Rating Scale （NRS）
Measured: Pain score will be evaluated at time point of operation, 1，6，24, 48 hours after operation, using NRS score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Jan 2018 (estimated)
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Jun 2019 (estimated)
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 Delirium in Old AgeStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dexmedetomidine group：dexmedetomidine is given to patients under spinal anesthesia until the end of surgery propofol group:Propofol is given to patients uunder spinal anesthesia until the end of surgery
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Guangxi Medical University, The Second Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Nanchang University, Qianfoshan Hospital, Shanghai 6th People's Hospital, Tang-Du Hospital, Second Hospital of Shanxi Medical University, The First Affiliated Hospital of Soochow University, Shanghai Changzheng Hospital, The Fuzhou No 2 Hospital, Foshan Hospital of Traditional Chinese Medicine, Beijing Jishuitan Hospital
- Responsible party
- Principal investigator, Guowei Tu, Shanghai Zhongshan Hospital
- Investigators
- Xue ZhangGang, doctor, Principal investigator, Anesthesiology Department of Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346226
- Sponsor's protocol ID
- Postoperative Delirium
- Status last verified
- Dec 2017
- First submitted
- 14 Sep 2017
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang L, Su Z, Zhang X. Postoperative Delirium After Dexmedetomidine versus Propofol Sedation in Older Adults Undergoing Hip Fracture Surgery with Spinal Anesthesia: A Randomized Controlled Trial. Drug Des Devel Ther. 2026 Aug 3;20:613342. doi: 10.2147/DDDT.S613342. eCollection 2026.
PubMed 42569644
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence on Incidence of Postoperative Delirium by Various Sedatives in Elderly Patients With Hip Fracture Under Lumbar Anesthesia: A Randomized, Control and Multi-center Trial
- ClinicalTrials.gov ID
- NCT03346226
- Acronym / sponsor ID
- Postoperative Delirium
- Conditions
- Delirium in Old Age
- Keywords
- Delirium Dexmedetomidine elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Guangxi Medical University, The Second Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Nanchang University, Qianfoshan Hospital, Shanghai 6th People's Hospital, Tang-Du Hospital, Second Hospital of Shanxi Medical University, The First Affiliated Hospital of Soochow University, Shanghai Changzheng Hospital, The Fuzhou No 2 Hospital, Foshan Hospital of Traditional Chinese Medicine, Beijing Jishuitan Hospital
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the hypothesis is that Dexmedetomidine seems to decrease incidence of post-operative delirium . one possible mechanism is that Dex have a minor influence on cognition, since it has no effect on GABA receptor，another is that Dex could induce a sleep similar to natural sleep, thereby decreasing sleep deprivation and circadian rhythm disorder in post-operative patients.
In this study , investigators devise the two different sedatives(Dexmedetomidine and Propofol)'influence on postoperative delirium in hip fracture elderly participants under spinal anesthesia
Detailed description
With a complex etiology, delirium is usually caused by various peri-operative stimuli on basis of predisposing factors, including senility, hypoxia and hypotension, pain, drug (such as pethidine, benzodiazepine, anticholinergic, and drug withdrawal), complications prior to surgery, post-operative sleep disorder. As for the mechanism of delirium, the commonly accepted hypothesis includes the decreased central cholinergic neurons function and the inflammation of central nervous system. Most of the hip fracture patients are senile, suffering generally from many complications with exposure to many drugs, and poor in nutritional status with decreased cognitive function even before the surgery in some of them, all of which are risk factors for post-operative delirium. Systematic review suggests that incidence of POD in patients undergoing elective hip arthroplasty is up to 4-53.3%. It is of great importance, therefore, to explore the effective approaches to lower POD incidence in senile patients with operation on hip fracture.
Dexmedetomidine Hydrochloride is a novel highly-selective α2 adrenergic receptor agonist, and its selectivity to α2 receptor is 8 times of that of clonidine. It has multiple functions including sedation, anti-anxiety, hypnosis, analgesia and sympathetic blockade, with a wide application prospect for peri-operative patients. Researches suggest that Dex applied peri-operatively may stabilize blood pressure and heart rate, control intra-operative stress, and decrease post-operative side reactions such as nausea, vomiting, restlessness, delirium and chills. Moreover, advantages of Dex also include analgesia and reduction of opioid usage. Clinical pharmacological characteristics of Dex suggest its possible function to decrease post-operative delirium. Meanwhile, Dex seems to have a minor influence on cognition, since it has no effect on GABA receptor.
Another important feature of it is that Dex induces a sleep similar to natural sleep, thereby decreasing sleep deprivation and circadian rhythm disorder in post-operative patients, and decreasing incidence of post-operative delirium. Researches evaluating the capability of Dex to decrease delirium incidence are focused on ICU sedation post to operation. Riker et al compared the sedative effect between Dex and midazolam in patients with severe mechanical ventilation, revealing a lower delirium incidence in Dex than in midazolam (54.0% vs 76.6%) in patients maintained with the same depth of sedation. Systematic review concludes that Dex in effective to prevent and treat post-operative delirium in ICU patients.
In this study ,the investigators devise the two different sedatives (Dexmedetomidine and Propofol)'influence on postoperative delirium in hip fracture elderly participants under spinal anesthesia
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Dexmedetomidine group：dexmedetomidine is given to patients under spinal anesthesia until the end of surgery propofol group:Propofol is given to patients uunder spinal anesthesia until the end of surgery
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Hydrochloride | Experimental | Drug: Dexmedetomidine HydrochlorideDex Group: 0.5 μg/kg of Dex is given 10 minutes before operation through injection pump during 15 minutes. After the operation starts, the initial pumping ratio of Dex is 0.5ug/kg/h and adjusted under BIS surveillance to keep BIS between 70-80 until 30 minutes before the end of surgery. Meanwhile, OAA/S grade is evaluated every 15 minutes to maintain OAA/S at grade 4. If discrepancy occurs, OAA/S prevails. |
| Propofol | Active comparator | Drug: PropofolProp Group: Propofol is given with an initial ratio of 2-10mg/kg/h, when the operation starts. Under BIS surveillance, dripping rate is adjusted to keep BIS between 70-80 until 5 minutes before the end of surgery. Meanwhile, OAA/S grade is evaluated every 15 minutes to maintain OAA/S at grade 4. If discrepancy occurs, OAA/S prevails. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Acquisition of informed consent,
- Patients with hip fracture surgery under lumbar anesthesia,
- Grade II to III based on American Society of Anesthesiologists ASA classification,
- Age ≥65 and ≤90 years old.
Key exclusion criteria (14 listed)
- History of psychiatric disease or a disease needing long-term exposure to psychotropic drugs (dementia, schizophrenia), or history of alcoholic abuse.
- More than 8 errors in preoperative Simplified Psychology and Mental Status Questionnaire (SPMSQ) , and diagnosed as severe cognitive impairment.
- CAM positive diagnosed preoperatively.
- Any cerebrovascular accident occurring within 3 months, such as cerebral stroke or transient ischemic attack (TIA).
- Systolic pressure < 90mmHg and diastolic pressure < 60mm Hg at the preoperative follow up or HR< 50/minute.
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 |
|---|---|---|
| Dexmedetomidine HydrochlorideAlso: brand name ：YiSiDexmedetomidine is given to patients during spinal anesthesia at the dose of 0.5 μg/kg，adjusted the dose to keep BIS between 70-80 until 30 minutes before the end of surgery | Drug | Dexmedetomidine Hydrochloride |
| PropofolAlso: Brand name：Diprivan or other brands of propofolPropofol is given with an initial ratio of 2-10mg/kg/h, when the operation starts，adjust the propofol's dose to keep BIS between 70-80 before the end of surgery | Drug | Propofol |
Primary outcome
occurrence of postoperative delirium in postoperative 72 hours
Time frame: patient enrolled will be evaluated at 9Am and 3Pm during post-operative day 1-3 (POD1-3).At any time point above，delirium is detected，then the patient will be diagnosed as postoperative delirium. All patients enrolled is Non-delirium before surgery。
Evaluation of delirium is performed by trained investigational assistant who does not know the randomization of patients. Follow up is carried out before operation and at 9Am and 3Pm during post-operative day 1-3 (POD1-3). During follow up, RASS (Richmond Agitation-Sedation Scale, RASS) is used firstly to evaluate sedation of the patients, and for those with ARSS >-4 (-3～+4), the Confusion Assessment Method (CAM) is adopted for evaluation. A case consistent with delirium standard at any time point during follow up is determined to be delirium positive. Diagnosis should be confirmed for a CAM-positive patient by a psychological expert based on DSM-V standard
7 secondary outcomes
Consumption of analgesic
Time frame: record the data of comsumption of analgeisic at 48 hours after operation
Times of intra-operative occurrence of hypotension, bradycardia, hypertension and tachycardia that need treatment.
Time frame: during the operation
Score of quality of post-operative sleeping
Time frame: quality of sleeping will be assessed at 9Am during post-operative day 1-3
Hospital stay
Time frame: record the days of hospital stay at the 30 days after surgery
Post-operative complications besides delirium
Time frame: observe and evaluate complications at the 30 days after surgery
Mortality up to day 30 post to operation
Time frame: the data will be collected after 30 days of operation
pain score
Time frame: Pain score will be evaluated at time point of operation, 1，6，24, 48 hours after operation, using NRS score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Derived from this study: PubMed 42569644Zhang L, Su Z, Zhang X. Postoperative Delirium After Dexmedetomidine versus Propofol Sedation in Older Adults Undergoing Hip Fracture Surgery with Spinal Anesthesia: A Randomized Controlled Trial. Drug Des Devel Ther. 2026 Aug 3;20:613342. doi: 10.2147/DDDT.S613342. eCollection 2026.
Related trials for Delirium in Old Age
RecruitingObservational study
Quality Contract: Prevention of Postoperative Delirium in the Care of Older Patients (QV-POD-2)
Delirium in Old Age
Active, not recruiting
Multi-Component Delirium Prevention Bundle in Older Cardiac Intensive Care Unit Patients
Delirium in Old Age, Delirium in the Intensive Care Unit
RecruitingPhase 3
The SCOPE Trial: Sleep, Cognition, and Pain Bundle vs. ERAS-cardiac for Postoperative Delirium
Delirium, Postoperative, Delirium in Old Age
Recruiting
Researching Efficient Approaches to Delirium Identification-Sustaining Effective Translation
Delirium, Delirium in Old Age
Not yet recruiting
Management of Non-pharmacologic Delirium With the Use of a Nursing-led E-health Project: a Randonmized Controlled Trial
Delirium Treatment, Delirium Confusional State
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.
Xue ZhangGang, doctor principal investigator
Anesthesiology Department of Shanghai Zhongshan Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine Hydrochloride and Propofol in people with Delirium in Old Age, run by Shanghai Zhongshan Hospital.
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 14 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 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhang XiaoGuang, Doctor (+86 13641995733, zhangxg@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of postoperative delirium in postoperative 72 hours (time frame: patient enrolled will be evaluated at 9Am and 3Pm during post-operative day 1-3 (POD1-3).At any time point above，delirium is detected，then the patient will be diagnosed as postoperative delirium. All patients enrolled is Non-delirium before 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 NCT03346226, 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 13 Dec 2017; AzTrials last refreshed its copy on 6 Nov 2026.