The Preventive Effect of Different Doses of Intranasal Insulin on Postoperative Delirium

NCT06443957 | Completed

• 1 other identifier: 23K214-001
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Delirium

Keywords

Postoperative delirium; Insulin; Intranasal administration

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  On the 1st postoperative day, the 2nd postoperative day, and the 3rd postoperative day,

• Lactate content in cerebrospinal fluid

  During the anesthesia

• Blood glucose values

  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

  During the anesthesia

Study Arms (3)

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.

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.

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.

Drug: Intranasal insulin-40U

Interventions

Intranasal normal saline DRUG

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 normal saline

Intranasal insulin-20U DRUG

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-20U

Intranasal insulin-40U DRUG

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.

Intranasal insulin-40U

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The first hospital of Jilin University

Changchun, China

Location

Related Publications (5)

• Marcantonio ER. Delirium in Hospitalized Older Adults. N Engl J Med. 2017 Oct 12;377(15):1456-1466. doi: 10.1056/NEJMcp1605501.

  PMID: 29020579 RESULT

• 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: 28973626 RESULT

• 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: 32568367 RESULT

• 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: 33757723 RESULT

• 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.

  PMID: 40222886 DERIVED

MeSH Terms

Conditions

Emergence Delirium; Insulin Resistance

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: June 5, 2024
• Study Start: July 29, 2023
• Primary Completion: April 13, 2024
• Study Completion: April 13, 2024
• Last Updated: June 5, 2024

Record last verified: 2023-08

Locations

CN (1)