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Intranasal administration of Insulin on the incidence of Postoperative Delirium in Middle-aged Patients Undergoing Elective Cardiopulmonary Bypass Cardiac Surgery: A prospective randomized control study

Intranasal administration of Insulin on the incidence of Postoperative Delirium in Middle-aged Patients Undergoing Elective Cardiopulmonary Bypass Cardiac Surgery: A prospective randomized control study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081444
Enrollment
Unknown
Registered
2024-03-01
Start date
2024-03-04
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative delirium

Interventions

Intranasally administered insulin(INI) group:Intranasal insulin (INI) administration, at a dosage of 0.5 ml containing 20 IU
Control group:patients receiving a intranasally administered 0.5 ml injection of 0.9% normal saline.

Sponsors

Department of Anesthesiology, Xinqiao Hospital of Chongqing, Second Afliated Hospital of Army Medical University, PLA, Chongqing 400037, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 45-65 years scheduled for elective cardiac surgery 2. Capable of engaging in concise communication with the investigator and successfully conducting the assessment using relevant scales 3. Mini-Mental Status Examination (MMSE) score greater than 17 4. Willing to participate in this study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. ASA I-III 2. Allergy to insulin 3. BMI > 35 kg/m2 4. History of mental illness or taking psychotropic drugs 5. Combined with diabetes 6. Combined with cerebral infarction or stroke 7. Long-term use of analgesics or sedatives 8. History of drug abuse, alcohol or opioid abuse 9. Chronic pain or recent acute pain 10. Contraindicated for nasal administration 11. Participants retain the right to withdraw from the study at their discretion for any reason, or if researchers deem their inclusion in the trial inappropriate.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative delirium (within 4 days);

Secondary

MeasureTime frame
duration of Intensice Care Unit (ICU);postoperative hospital length of stay;all in-hospital mortality;the change in MMSE scores pre- and post-operation;incidence of postoperative cognitive dysfunction at 1 month;incidence of postoperative cognitive dysfunction at 3 month;incidence of postoperative cognitive dysfunction at 6 month;

Countries

China

Contacts

Public ContactGuiying Yang

Department of Anesthesiology, Xinqiao Hospital of Chongqing, Second Afliated Hospital of Army Medical University, PLA, Chongqing 400037, China

472151685@qq.com+86 136 9648 6560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026