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Efficacy trial of intranasal insulin

Effects of Intranasal insulin administration for postoperative delirium in cardiac surgery patients - prospective multi-center double blind randomised trial -

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031230047
Enrollment
110
Registered
2023-04-21
Start date
2023-07-05
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Elective cardiac surgery requiring cardiopulmonary bypass valvular diseases, Ischemic heart diseases

Interventions

Insulin, intranasal administration,perioperative

Sponsors

Nakadate Yosuke
Lead Sponsor
Department fund (Department of Anesthesiology, University of Tsukuba)
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients undergoing elective cardiac surgery requiring cardiopulmonary bypass 2) Patients who are 65 years old or older 3) Patietns who had not undergone nasal surgery 4) Patiets who provide signed informed consent to participate in the registry

Exclusion criteria

Exclusion criteria: 1) Patietns with preoperative delirium 2) Patients whose preoperative MMSE examination is 23 or less 3) Patients undergone cardiac surgery under hypothermia (< 32 degree celcius) condition 4) Patients with insulin allergy 5) Patietns with severe phycological disorder 6) Patients with severe neurological disorder 7) Patietns with severe hearing and/or visual impairment 8) Patients with Japanese language disability 9) Patients who are judged inappropriate by researchers

Design outcomes

Primary

MeasureTime frame
Incidence of delirium within 7 days after surgery

Secondary

MeasureTime frame
1) Days of postoperative delirium 2) Number of postoperative delirium 3) Change in MMSE-J score at 7days after surgery compared to before surgery 4) Change in MoCA-J score at 7days after surgery compared to before surgery 5) Postoperative pain score (Numerical rating scale) 6) Postoperative tracheal intubation time 7) Length of intensive care unit stay 8) Incidence of hypoglycemia 9) Incidence of postoperataive renal 10) Incidence of postoperative heart failure 11) Incidence of postoperative infection 12) Incidence of atrial fibrillation 13) Postoperative 7-day mortality rate 14) Incidence of all of adverse events

Contacts

Public ContactYosuke Nakadate

University of Tsukuba Hospital

nakadate.ge@md.tsukuba.ac.jp+81-29-853-3092

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026