Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-25 @ 3:01 AM
Study NCT ID:
NCT06443957
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2024-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Preventive Effect of Different Doses of Intranasal Insulin on Postoperative Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-30', 'studyFirstSubmitDate': '2024-05-07', 'studyFirstSubmitQcDate': '2024-05-30', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative delirium', 'timeFrame': 'From 18:00 to 19:00 on the 1st postoperative day, the 2nd postoperative day, and the 3rd postoperative day,', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'visual analogue scale', 'timeFrame': 'On the 1st postoperative day, the 2nd postoperative day, and the 3rd postoperative day,', 'description': 'Assess postoperative pain，0 represents painless, 10 represents severe pain, and the higher the score, the more severe the pain will be.'}, {'measure': 'Lactate content in cerebrospinal fluid', 'timeFrame': 'During the anesthesia', 'description': 'The patient underwent neuraxial anesthesia to obtain 0.5ml of cerebrospinal fluid and measure the lactate content in the cerebrospinal fluid'}, {'measure': 'Blood glucose values', 'timeFrame': '1 day before the operation, 40 minutes after nasal administration of insulin or normal saline, before surgery and immediately after surgery', 'description': "A blood glucose meter is used to measure the patient's fingerstick blood glucose"}, {'measure': 'Glucose content in cerebrospinal fluid', 'timeFrame': 'During the anesthesia', 'description': 'The patient underwent neuraxial anesthesia to obtain 0.5ml of cerebrospinal fluid and measure the glucose content in the cerebrospinal fluid'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative delirium', 'Insulin', 'Intranasal administration'], 'conditions': ['Postoperative Delirium']}, 'referencesModule': {'references': [{'pmid': '29020579', 'type': 'RESULT', 'citation': 'Marcantonio ER. Delirium in Hospitalized Older Adults. N Engl J Med. 2017 Oct 12;377(15):1456-1466. doi: 10.1056/NEJMcp1605501.'}, {'pmid': '28973626', 'type': 'RESULT', 'citation': 'Oh 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.'}, {'pmid': '32568367', 'type': 'RESULT', 'citation': 'Craft 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.'}, {'pmid': '33757723', 'type': 'RESULT', 'citation': 'Huang 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.'}, {'pmid': '40222886', 'type': 'DERIVED', 'citation': 'Li 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with hip fracture scheduled for unilateral hip arthroplasty or intramedullary nailing under subarachnoid block.\n\nBoth genders. Age ≥65 years old. Body mass index (BMI) ≤24kg/m2. American Society of Anesthesiologists (ASA) grade I-III.\n\nExclusion Criteria:\n\nContraindications to nasal administration (nasal defects or lesions). History of insulin allergy. Inability to communicate preoperatively (coma, severe visual or hearing impairment).\n\nHistory of severe heart,Liver and kidney disease. History of psychiatric disorders. Preoperative delirium. Multiple traumas or fractures. Contraindications to subarachnoid block.'}, 'identificationModule': {'nctId': 'NCT06443957', 'briefTitle': 'The Preventive Effect of Different Doses of Intranasal Insulin on Postoperative Delirium', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '23K214-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Intranasal normal saline', 'description': '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.', 'interventionNames': ['Drug: Intranasal normal saline']}, {'type': 'EXPERIMENTAL', 'label': 'Intranasal insulin-20U', 'description': '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.', 'interventionNames': ['Drug: Intranasal insulin-20U']}, {'type': 'EXPERIMENTAL', 'label': 'Intranasal insulin-40U', 'description': '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.', 'interventionNames': ['Drug: Intranasal insulin-40U']}], 'interventions': [{'name': 'Intranasal normal saline', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Intranasal normal saline']}, {'name': 'Intranasal insulin-20U', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Intranasal insulin-20U']}, {'name': 'Intranasal insulin-40U', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Intranasal insulin-40U']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changchun', 'country': 'China', 'facility': 'The first hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}