jRCTs031230047
Recruiting
Not Applicable
Effects of Intranasal insulin administration for postoperative delirium in cardiac surgery patients - prospective multi-center double blind randomised trial -
Not provided0 sites110 target enrollmentStarted: July 5, 2023Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 110
- Primary Endpoint
- -
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention Purpose
- Masking
- Double Blind
Eligibility Criteria
- Ages
- 65age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •Patients undergoing elective cardiac surgery requiring cardiopulmonary bypass
- •Patients who are 65 years old or older
- •Patietns who had not undergone nasal surgery
- •Patiets who provide signed informed consent to participate in the registry
Exclusion Criteria
- •Patietns with preoperative delirium
- •Patients whose preoperative MMSE examination is 23 or less
- •Patients undergone cardiac surgery under hypothermia (< 32 degree celcius) condition
- •Patients with insulin allergy
- •Patietns with severe phycological disorder
- •Patients with severe neurological disorder
- •Patietns with severe hearing and/or visual impairment
- •Patients with Japanese language disability
- •Patients who are judged inappropriate by researchers
Outcomes
Primary Outcomes
-
Incidence of delirium within 7 days after surgery
Secondary Outcomes
- Change in MMSE-J score(7days after surgery compared to before surgery)
- Change in MoCA-J score(7days after surgery compared to before surgery)
- Postoperative pain score
Investigators
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