Postoperative DeliriumNCT06443957
The Preventive Effect of Different Doses of Intranasal Insulin on Postoperative Delirium
A study testing Intranasal normal saline, Intranasal insulin-20U and Intranasal insulin-40U in people with Postoperative Delirium, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
Postoperative delirium is one of the common complications in the older aldults after surgery, which can lead to longer hospita stay，memory loss and reduced quality of life. There is currently no specific treatment. Therefore, it is important to prevent the occurrence of postoperative delirium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Intranasal normal saline, Intranasal insulin-20U and Intranasal insulin-40U
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteChina
- Study dates
- 29 Jul 2023to 13 Apr 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hip fracture scheduled for unilateral hip arthroplasty or intramedullary nailing under subarachnoid block.
- Both genders. Age ≥65 years old. Body mass index (BMI) ≤24kg/m2. American Society of Anesthesiologists (ASA) grade I-III.
Who cannot join
- Contraindications to nasal administration (nasal defects or lesions). History of insulin allergy. Inability to communicate preoperatively (coma, severe visual or hearing impairment).
- History of severe heart,Liver and kidney disease. History of psychiatric disorders. Preoperative delirium. Multiple traumas or fractures. Contraindications to subarachnoid block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Preventive Effect and Safety of Different Doses of Insulin Nasal Administration on Postoperative Delirium in Elderly Hip Fracture Patients - a Randomized, Single Blind, Parallel Controlled, Single Center Clinical Trial
Postoperative delirium is one of the common complications in the older aldults after surgery, which can lead to longer hospita stay，memory loss and reduced quality of life. There is currently no specific treatment. Therefore, it is important to prevent the occurrence of postoperative delirium. This study investigated the effect of intranasal insulin administration on the prevention of postoperative delirium and compared different doses of insulin to find a safe and acceptable method for preventing delirium.
Read the detailed description
Hip fractures are a common trauma in older adults and occur mainly in older people with osteoporosis. Surgery is the preferred choice for the vast majority of patients with severe pain and limited mobility in older aldults with hip fractures, resulting in higher mortality and disability rates with conservative treatment. But postoperative delirium becomes a challenge. At present, the treatment of delirium includes pharmacological and non-pharmacological methods, but the effect is limited, and now the focus is on preventing delirium, so this study investigated the effect of intranasal insulin administration on the prevention of postoperative delirium.
- Conditions
- Postoperative Delirium
- Being tested
- Intranasal normal saline, Intranasal insulin-20U, Intranasal insulin-40U
- Keywords
- Postoperative delirium, Insulin, Intranasal administration
- Medical subject headings
- Emergence Delirium, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal normal salineDrug
The patient was given 1ml of normal saline intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery.
Intranasal insulin-20UDrug
The patient was given 1ml of 20U insulin intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery.
Intranasal insulin-40UDrug
The patient was given 1ml of 40U insulin intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal normal saline | Placebo comparator | The patient was given 1ml of normal saline intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery. Receives: Drug: Intranasal normal saline |
| Intranasal insulin-20U | Experimental | The patient was given 1ml of 20U insulin intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery. Receives: Drug: Intranasal insulin-20U |
| Intranasal insulin-40U | Experimental | The patient was given 1ml of 40U insulin intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery. Receives: Drug: Intranasal insulin-40U |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative delirium
The CAM-ICU scale is used to evaluate whether postoperative delirium occurs in three groups of patients. The scale is divided into four parts: acute changes and fluctuations in consciousness state, attention disorders, changes in consciousness level, and cognitive confusion. If acute changes in consciousness and attention deficit occur simultaneously, combined with changes in consciousness level and cognitive confusion, either can be diagnosed as postoperative delirium.
Measured: From 18:00 to 19:00 on the 1st postoperative day, the 2nd postoperative day, and the 3rd postoperative day,
Secondary outcomes (4)
visual analogue scale
Assess postoperative pain，0 represents painless, 10 represents severe pain, and the higher the score, the more severe the pain will be.
Measured: On the 1st postoperative day, the 2nd postoperative day, and the 3rd postoperative day,
Lactate content in cerebrospinal fluid
The patient underwent neuraxial anesthesia to obtain 0.5ml of cerebrospinal fluid and measure the lactate content in the cerebrospinal fluid
Measured: During the anesthesia
Blood glucose values
A blood glucose meter is used to measure the patient's fingerstick blood glucose
Measured: 1 day before the operation, 40 minutes after nasal administration of insulin or normal saline, before surgery and immediately after surgery
Glucose content in cerebrospinal fluid
The patient underwent neuraxial anesthesia to obtain 0.5ml of cerebrospinal fluid and measure the glucose content in the cerebrospinal fluid
Measured: During the anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start29 Jul 2023
- Primary completion13 Apr 2024
- Study completion13 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443957
- Sponsor's protocol ID
- 23K214-001
- Status last verified
- Aug 2023
- First submitted
- 7 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marcantonio ER. Delirium in Hospitalized Older Adults. N Engl J Med. 2017 Oct 12;377(15):1456-1466. doi: 10.1056/NEJMcp1605501.
PubMed 29020579Oh ES, Fong TG, Hshieh TT, Inouye SK. Delirium in Older Persons: Advances in Diagnosis and Treatment. JAMA. 2017 Sep 26;318(12):1161-1174. doi: 10.1001/jama.2017.12067.
PubMed 28973626Craft S, Raman R, Chow TW, Rafii MS, Sun CK, Rissman RA, Donohue MC, Brewer JB, Jenkins C, Harless K, Gessert D, Aisen PS. Safety, Efficacy, and Feasibility of Intranasal Insulin for the Treatment of Mild Cognitive Impairment and Alzheimer Disease Dementia: A Randomized Clinical Trial. JAMA Neurol. 2020 Sep 1;77(9):1099-1109. doi: 10.1001/jamaneurol.2020.1840.
PubMed 32568367Huang Q, Li Q, Qin F, Yuan L, Lu Z, Nie H, Gong G. Repeated Preoperative Intranasal Administration of Insulin Decreases the Incidence of Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Radical Gastrointestinal Surgery: A Randomized, Placebo-Controlled, Double-Blinded Clinical Study. Am J Geriatr Psychiatry. 2021 Dec;29(12):1202-1211. doi: 10.1016/j.jagp.2021.02.043. Epub 2021 Feb 23.
PubMed 33757723Li Y, Zhang Y, Ren Y, Liu H. Optimal Dose of Intranasal Insulin Administration for Reducing Postoperative Delirium Incidence in Older Patients Undergoing Hip Fracture Surgery. Am J Geriatr Psychiatry. 2025 Aug;33(8):891-900. doi: 10.1016/j.jagp.2025.03.009. Epub 2025 Mar 21.
PubMed 40222886
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preventive Effect and Safety of Different Doses of Insulin Nasal Administration on Postoperative Delirium in Elderly Hip Fracture Patients - a Randomized, Single Blind, Parallel Controlled, Single Center Clinical Trial
- ClinicalTrials.gov ID
- NCT06443957
- Acronym / sponsor ID
- 23K214-001
- Conditions
- Postoperative Delirium
- Keywords
- Postoperative delirium, Insulin, Intranasal administration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 29 Jul 2023 (actual)
- Primary completion
- 13 Apr 2024 (actual)
- Study completion
- 13 Apr 2024 (actual)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative delirium is one of the common complications in the older aldults after surgery, which can lead to longer hospita stay，memory loss and reduced quality of life. There is currently no specific treatment. Therefore, it is important to prevent the occurrence of postoperative delirium. This study investigated the effect of intranasal insulin administration on the prevention of postoperative delirium and compared different doses of insulin to find a safe and acceptable method for preventing delirium.
Detailed description
Hip fractures are a common trauma in older adults and occur mainly in older people with osteoporosis. Surgery is the preferred choice for the vast majority of patients with severe pain and limited mobility in older aldults with hip fractures, resulting in higher mortality and disability rates with conservative treatment. But postoperative delirium becomes a challenge. At present, the treatment of delirium includes pharmacological and non-pharmacological methods, but the effect is limited, and now the focus is on preventing delirium, so this study investigated the effect of intranasal insulin administration on the prevention of postoperative delirium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intranasal normal saline | Placebo comparator | Drug: Intranasal normal salineThe patient was given 1ml of normal saline intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery. |
| Intranasal insulin-20U | Experimental | Drug: Intranasal insulin-20UThe patient was given 1ml of 20U insulin intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery. |
| Intranasal insulin-40U | Experimental | Drug: Intranasal insulin-40UThe patient was given 1ml of 40U insulin intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with hip fracture scheduled for unilateral hip arthroplasty or intramedullary nailing under subarachnoid block.
- Both genders. Age ≥65 years old. Body mass index (BMI) ≤24kg/m2. American Society of Anesthesiologists (ASA) grade I-III.
Key exclusion criteria (2 listed)
- Contraindications to nasal administration (nasal defects or lesions). History of insulin allergy. Inability to communicate preoperatively (coma, severe visual or hearing impairment).
- History of severe heart,Liver and kidney disease. History of psychiatric disorders. Preoperative delirium. Multiple traumas or fractures. Contraindications to subarachnoid block.
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 normal salineThe patient was given 1ml of normal saline intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery. | Drug | Intranasal normal saline |
| Intranasal insulin-20UThe patient was given 1ml of 20U insulin intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery. | Drug | Intranasal insulin-20U |
| Intranasal insulin-40UThe patient was given 1ml of 40U insulin intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery. | Drug | Intranasal insulin-40U |
Primary outcome
postoperative delirium
Time frame: From 18:00 to 19:00 on the 1st postoperative day, the 2nd postoperative day, and the 3rd postoperative day,
The CAM-ICU scale is used to evaluate whether postoperative delirium occurs in three groups of patients. The scale is divided into four parts: acute changes and fluctuations in consciousness state, attention disorders, changes in consciousness level, and cognitive confusion. If acute changes in consciousness and attention deficit occur simultaneously, combined with changes in consciousness level and cognitive confusion, either can be diagnosed as postoperative delirium.
4 secondary outcomes
visual analogue scale
Time frame: On the 1st postoperative day, the 2nd postoperative day, and the 3rd postoperative day,
Lactate content in cerebrospinal fluid
Time frame: During the anesthesia
Blood glucose values
Time frame: 1 day before the operation, 40 minutes after nasal administration of insulin or normal saline, before surgery and immediately after surgery
Glucose content in cerebrospinal fluid
Time frame: During the anesthesia
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 5 Jun 2024.
- Results publication: PubMed 29020579Marcantonio ER. Delirium in Hospitalized Older Adults. N Engl J Med. 2017 Oct 12;377(15):1456-1466. doi: 10.1056/NEJMcp1605501.
- Results publication: PubMed 28973626Oh ES, Fong TG, Hshieh TT, Inouye SK. Delirium in Older Persons: Advances in Diagnosis and Treatment. JAMA. 2017 Sep 26;318(12):1161-1174. doi: 10.1001/jama.2017.12067.
- Results publication: PubMed 32568367Craft S, Raman R, Chow TW, Rafii MS, Sun CK, Rissman RA, Donohue MC, Brewer JB, Jenkins C, Harless K, Gessert D, Aisen PS. Safety, Efficacy, and Feasibility of Intranasal Insulin for the Treatment of Mild Cognitive Impairment and Alzheimer Disease Dementia: A Randomized Clinical Trial. JAMA Neurol. 2020 Sep 1;77(9):1099-1109. doi: 10.1001/jamaneurol.2020.1840.
- Results publication: PubMed 33757723Huang Q, Li Q, Qin F, Yuan L, Lu Z, Nie H, Gong G. Repeated Preoperative Intranasal Administration of Insulin Decreases the Incidence of Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Radical Gastrointestinal Surgery: A Randomized, Placebo-Controlled, Double-Blinded Clinical Study. Am J Geriatr Psychiatry. 2021 Dec;29(12):1202-1211. doi: 10.1016/j.jagp.2021.02.043. Epub 2021 Feb 23.
- Derived from this study: PubMed 40222886Li Y, Zhang Y, Ren Y, Liu H. Optimal Dose of Intranasal Insulin Administration for Reducing Postoperative Delirium Incidence in Older Patients Undergoing Hip Fracture Surgery. Am J Geriatr Psychiatry. 2025 Aug;33(8):891-900. doi: 10.1016/j.jagp.2025.03.009. Epub 2025 Mar 21.
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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 Intranasal normal saline, Intranasal insulin-20U and Intranasal insulin-40U in people with Postoperative Delirium, run by The First Hospital of Jilin 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 2 inclusion and 2 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 5 Jun 2024. 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 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 (time frame: From 18:00 to 19:00 on the 1st postoperative day, the 2nd postoperative day, and the 3rd postoperative day,). 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 NCT06443957, which also lists 5 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 5 Jun 2024.